Trial Outcomes & Findings for Platelet Rich Plasma vs Hyaluronic-Acid in Hip OA (Osteoarthritis) (NCT NCT01920152)
NCT ID: NCT01920152
Last Updated: 2021-03-03
Results Overview
To measure duration of clinical benefit, survivorship was analyzed by investigating the frequency of patient withdrawal of their treated hip to undergo surgery (total hip arthroplasty \[THA\] or hip resurfacing procedure). Survivorship was evaluating hips, not patients in this outcome measure. This served as the primary outcome measure for the study.
COMPLETED
NA
38 participants
Baseline, 24 Months
2021-03-03
Participant Flow
Participants were recruited from current patient population or first-time patients of the Hip Preservation Clinic or the Joint Clinic between 2013 and 2018. Participants were identified and recruited during routine office visits. The first participant was enrolled on December 5th, 2013 and the last participant was enrolled in December 2017.
There were 63 participants assessed for eligibility. Of the 38 enrolled participants, 34 participants (36 hips) met the inclusion criteria and were randomized to treatment.
Unit of analysis: Hips
Participant milestones
| Measure |
Autologous PRP Hip Injection
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Overall Study
STARTED
|
19 20
|
15 16
|
|
Overall Study
COMPLETED
|
18 19
|
13 14
|
|
Overall Study
NOT COMPLETED
|
1 1
|
2 2
|
Reasons for withdrawal
| Measure |
Autologous PRP Hip Injection
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Platelet Rich Plasma vs Hyaluronic-Acid in Hip OA (Osteoarthritis)
Baseline characteristics by cohort
| Measure |
Autologous PRP Hip Injection
n=19 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=14 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
Total
n=33 Hips
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 8.4 • n=42 Hips
|
54.5 years
STANDARD_DEVIATION 9.0 • n=14 Hips
|
53.8 years
STANDARD_DEVIATION 8.5 • n=33 Hips
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
13 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
BMI
|
23.7 Kg/m^2
STANDARD_DEVIATION 2.1 • n=42 Hips
|
23.5 Kg/m^2
STANDARD_DEVIATION 2.0 • n=14 Hips
|
23.6 Kg/m^2
STANDARD_DEVIATION 2.0 • n=33 Hips
|
|
Kellgren-Lawrence (KL) Grading Scale
KL Grade 2
|
7 Hips
n=42 Hips
|
2 Hips
n=14 Hips
|
9 Hips
n=33 Hips
|
|
Kellgren-Lawrence (KL) Grading Scale
KL Grade 3
|
12 Hips
n=42 Hips
|
12 Hips
n=14 Hips
|
24 Hips
n=33 Hips
|
|
Kellgren-Lawrence (KL) Grading Scale
KL Grade 4
|
0 Hips
n=42 Hips
|
0 Hips
n=14 Hips
|
0 Hips
n=33 Hips
|
|
Kellgren-Lawrence (KL) Grading Scale
KL Grade 0
|
0 Hips
n=42 Hips
|
0 Hips
n=14 Hips
|
0 Hips
n=33 Hips
|
|
Kellgren-Lawrence (KL) Grading Scale
KL Grade 1
|
0 Hips
n=42 Hips
|
0 Hips
n=14 Hips
|
0 Hips
n=33 Hips
|
PRIMARY outcome
Timeframe: Baseline, 24 MonthsTo measure duration of clinical benefit, survivorship was analyzed by investigating the frequency of patient withdrawal of their treated hip to undergo surgery (total hip arthroplasty \[THA\] or hip resurfacing procedure). Survivorship was evaluating hips, not patients in this outcome measure. This served as the primary outcome measure for the study.
Outcome measures
| Measure |
Autologous PRP Hip Injection
n=19 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=14 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Survivorship, as Measured by the Frequency of Patient Withdrawal of Their Treated Hip to Undergo Surgery (Total Hip Arthroplasty [THA] or Hip Resurfacing Procedure).
|
3 Hips
|
7 Hips
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: The overall number analyzed decreased in the PRP group due to a participant withdrawing from the study to undergo a total hip replacement at week 12.
The primary efficacy outcome was defined as the percentage of patients having a 50% decrease in the summed score for the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain sub-score from baseline to week 24. The WOMAC score is a normalized patient-reported outcome measure in which 0 represents the worst possible score and 100 represents the best possible score. The WOMAC is primarily used in osteoarthritis clinical trials to evaluate the effects of arthroplasty and drug interventions in patients with hip osteoarthritis. Thus, a 50% increase in the WOMAC pain sub-score would indicate reduced pain or improvement, while a 50% decrease would indicate worsening pain.
Outcome measures
| Measure |
Autologous PRP Hip Injection
n=18 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=14 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Sub-score
≥50% Decrease in WOMAC Pain (Worse)
|
0 Hips
|
0 Hips
|
|
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Sub-score
≥50% Increase in WOMAC Pain (Better)
|
2 Hips
|
0 Hips
|
SECONDARY outcome
Timeframe: BaselinePopulation: The number analyzed for some of the WOMAC subscores differs from the overall number analyzed due to item non-response.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score was defined as the secondary outcome measurement. The WOMAC score is a normalized patient-reported outcome measure in which 0 represents the worst possible score and 100 represents the best possible score. The WOMAC is primarily used in osteoarthritis clinical trials to evaluate the effects of arthroplasty and drug interventions in patients with hip osteoarthritis.
Outcome measures
| Measure |
Autologous PRP Hip Injection
n=19 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=14 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Baseline
WOMAC Pain
|
72.1 score on a scale
Standard Deviation 18.0
|
78.9 score on a scale
Standard Deviation 14.3
|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Baseline
WOMAC Joint
|
55.3 score on a scale
Standard Deviation 26.5
|
68.8 score on a scale
Standard Deviation 24.9
|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Baseline
WOMAC Function
|
69.6 score on a scale
Standard Deviation 20.4
|
81.2 score on a scale
Standard Deviation 12.9
|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Baseline
WOMAC Overall
|
67.6 score on a scale
Standard Deviation 19.7
|
77.9 score on a scale
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: Week 6Population: The number analyzed for some of the WOMAC subscores differs from the overall number analyzed due to item non-response.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score was defined as the secondary outcome measurement. The WOMAC score is a normalized patient-reported outcome measure in which 0 represents the worst possible score and 100 represents the best possible score. The WOMAC is primarily used in osteoarthritis clinical trials to evaluate the effects of arthroplasty and drug interventions in patients with hip osteoarthritis.
Outcome measures
| Measure |
Autologous PRP Hip Injection
n=19 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=14 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 6
WOMAC Pain
|
80.8 score on a scale
Standard Deviation 12.4
|
80.0 score on a scale
Standard Deviation 17.1
|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 6
WOMAC Joint
|
71.5 score on a scale
Standard Deviation 15.9
|
75.0 score on a scale
Standard Deviation 23.4
|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 6
WOMAC Function
|
82.9 score on a scale
Standard Deviation 12.5
|
83.7 score on a scale
Standard Deviation 15.2
|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 6
WOMAC Overall
|
79.7 score on a scale
Standard Deviation 10.9
|
79.5 score on a scale
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: Week 12Population: The number analyzed for some of the WOMAC subscores differs from the overall number analyzed due to item non-response of a participant who underwent bilateral treatment in the HA group. The overall number analyzed decreased in the PRP group due to a participant withdrawing from the study to undergo a total hip replacement at week 12.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score was defined as the secondary outcome measurement. The WOMAC score is a normalized patient-reported outcome measure in which 0 represents the worst possible score and 100 represents the best possible score. The WOMAC is primarily used in osteoarthritis clinical trials to evaluate the effects of arthroplasty and drug interventions in patients with hip osteoarthritis.
Outcome measures
| Measure |
Autologous PRP Hip Injection
n=18 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=14 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 12
WOMAC Pain
|
80.8 score on a scale
Standard Deviation 12.0
|
79.2 score on a scale
Standard Deviation 18.0
|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 12
WOMAC Joint
|
68.8 score on a scale
Standard Deviation 19.8
|
71.2 score on a scale
Standard Deviation 29.2
|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 12
WOMAC Function
|
80.1 score on a scale
Standard Deviation 14.8
|
79.1 score on a scale
Standard Deviation 17.8
|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 12
WOMAC Overall
|
78.0 score on a scale
Standard Deviation 13.0
|
77.5 score on a scale
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: Week 24Population: The overall number analyzed decreased in the PRP group due to a participant withdrawing from the study to undergo a total hip replacement at week 12.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score was defined as the secondary outcome measurement. The WOMAC score is a normalized patient-reported outcome measure in which 0 represents the worst possible score and 100 represents the best possible score. The WOMAC is primarily used in osteoarthritis clinical trials to evaluate the effects of arthroplasty and drug interventions in patients with hip osteoarthritis.
Outcome measures
| Measure |
Autologous PRP Hip Injection
n=18 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=14 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 24
WOMAC Pain
|
76.1 score on a scale
Standard Deviation 15.1
|
84.3 score on a scale
Standard Deviation 14.5
|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 24
WOMAC Joint
|
72.9 score on a scale
Standard Deviation 22.8
|
74.1 score on a scale
Standard Deviation 22.2
|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 24
WOMAC Function
|
80.2 score on a scale
Standard Deviation 16.4
|
84.1 score on a scale
Standard Deviation 15.7
|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 24
WOMAC Overall
|
77.0 score on a scale
Standard Deviation 15.8
|
82.1 score on a scale
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: Fourteen participants (15 hips, 74%) in the PRP group reached a final follow-up of 24 months. Five participants (5 hips, 36%) in the HA group reached a final follow-up of 24 months.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score was defined as the secondary outcome measurement. The WOMAC score is a normalized patient-reported outcome measure in which 0 represents the worst possible score and 100 represents the best possible score. The WOMAC is primarily used in osteoarthritis clinical trials to evaluate the effects of arthroplasty and drug interventions in patients with hip osteoarthritis.
Outcome measures
| Measure |
Autologous PRP Hip Injection
n=15 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=5 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores
WOMAC Pain
|
6.67 score on a scale
Standard Deviation 15.99
|
0 score on a scale
Standard Deviation 18.37
|
|
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores
WOMAC Joint
|
12.5 score on a scale
Standard Deviation 28.74
|
-2.5 score on a scale
Standard Deviation 16.3
|
|
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores
WOMAC Function
|
9.81 score on a scale
Standard Deviation 16.45
|
-2.65 score on a scale
Standard Deviation 18.67
|
|
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores
WOMAC Overall
|
9.05 score on a scale
Standard Deviation 17.88
|
-1.51 score on a scale
Standard Deviation 14.14
|
SECONDARY outcome
Timeframe: BaselinePopulation: The number analyzed differs from the overall number analyzed due to missing data. It is important to note that some patients were unable to reach 0 degrees of hip IR and therefore the value was recorded as negative.
The range of motion (ROM) of the hip is reported for both groups of treatment. This includes external rotation (ER), internal rotation (IR), and flexion (FL).
Outcome measures
| Measure |
Autologous PRP Hip Injection
n=19 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=14 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Hip Range of Motion (ROM) at Baseline
IR
|
2.8 degrees
Standard Deviation 7.0
|
2.3 degrees
Standard Deviation 13.5
|
|
Hip Range of Motion (ROM) at Baseline
ER
|
36.1 degrees
Standard Deviation 12.9
|
36.4 degrees
Standard Deviation 10.8
|
|
Hip Range of Motion (ROM) at Baseline
FL
|
102.4 degrees
Standard Deviation 8.2
|
101.1 degrees
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: Week 6Population: The number analyzed differs from the overall number analyzed due to missing data. It is important to note that some patients were unable to reach 0 degrees of hip IR and therefore the value was recorded as negative.
The range of motion (ROM) of the hip is reported for both groups of treatment. This includes external rotation (ER), internal rotation (IR), and flexion (FL).
Outcome measures
| Measure |
Autologous PRP Hip Injection
n=19 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=14 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Hip Range of Motion (ROM) at Week 6
IR
|
3.3 degrees
Standard Deviation 6.6
|
0.9 degrees
Standard Deviation 14.1
|
|
Hip Range of Motion (ROM) at Week 6
ER
|
37.6 degrees
Standard Deviation 9.2
|
36.2 degrees
Standard Deviation 9.2
|
|
Hip Range of Motion (ROM) at Week 6
FL
|
99.6 degrees
Standard Deviation 7.8
|
99.2 degrees
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: Week 12Population: The number analyzed differs from the overall number analyzed due to missing data. It is important to note that some patients were unable to reach 0 degrees of hip IR and therefore the value was recorded as negative.
The range of motion (ROM) of the hip is reported for both groups of treatment. This includes external rotation (ER), internal rotation (IR), and flexion (FL).
Outcome measures
| Measure |
Autologous PRP Hip Injection
n=19 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=14 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Hip Range of Motion (ROM) at Week 12
IR
|
4.7 degrees
Standard Deviation 7.9
|
0.7 degrees
Standard Deviation 14.5
|
|
Hip Range of Motion (ROM) at Week 12
ER
|
34.6 degrees
Standard Deviation 12.2
|
35.7 degrees
Standard Deviation 8.7
|
|
Hip Range of Motion (ROM) at Week 12
FL
|
101.9 degrees
Standard Deviation 12.2
|
98.2 degrees
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Week 24Population: The number analyzed differs from the overall number analyzed due to missing data. The overall number analyzed decreased in the PRP group due to a participant withdrawing from the study to undergo a total hip replacement at week 12. It is important to note that some patients were unable to reach 0 degrees of hip IR and therefore the value was recorded as negative.
The range of motion (ROM) of the hip is reported for both groups of treatment. This includes external rotation (ER), internal rotation (IR), and flexion (FL).
Outcome measures
| Measure |
Autologous PRP Hip Injection
n=18 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=14 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Hip Range of Motion (ROM) at Week 24
IR
|
7.8 degrees
Standard Deviation 10.3
|
0.8 degrees
Standard Deviation 11.3
|
|
Hip Range of Motion (ROM) at Week 24
ER
|
36.8 degrees
Standard Deviation 10.1
|
38.5 degrees
Standard Deviation 7.5
|
|
Hip Range of Motion (ROM) at Week 24
FL
|
103.5 degrees
Standard Deviation 13.3
|
97.3 degrees
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Fourteen participants (15 hips, 74%) in the PRP group reached a final follow-up of 24 months. Five participants (5 hips, 36%) in the HA group reached a final follow-up of 24 months. It is important to note that some patients were unable to reach 0 degrees of hip IR and therefore the value was recorded as negative.
The range of motion (ROM) of the hip is reported for both groups of treatment. This includes external rotation (ER), internal rotation (IR), and flexion (FL).
Outcome measures
| Measure |
Autologous PRP Hip Injection
n=15 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=5 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Change in Hip Range of Motion (ROM)
FL
|
-2.5 degrees
Standard Deviation 8.49
|
0 degrees
Standard Deviation 5
|
|
Change in Hip Range of Motion (ROM)
IR
|
3.36 degrees
Standard Deviation 7.88
|
2.6 degrees
Standard Deviation 9.29
|
|
Change in Hip Range of Motion (ROM)
ER
|
-0.3571 degrees
Standard Deviation 13.65
|
0 degrees
Standard Deviation 11.73
|
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Fourteen participants (15 hips, 74%) in the PRP group reached a final follow-up of 24 months. Five participants (5 hips, 36%) in the HA group reached a final follow-up of 24 months.
The International Hip Outcome Tool (IHOT) score is reported for both groups of treatment as the change from baseline to 24 months post-injection. The iHOT12 instrument is a joint-specific PRO for evaluating quality of life (QoL). A score of 100 indicates excellent QoL (full function and no symptoms), whereas zero signifies the worst QoL (maximum limitations and extreme symptoms).
Outcome measures
| Measure |
Autologous PRP Hip Injection
n=15 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=5 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Change in International Hip Outcome Tool (IHOT)
|
20.61 score on a scale
Standard Deviation 22.59
|
-3.92 score on a scale
Standard Deviation 18.68
|
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Fourteen participants (15 hips, 74%) in the PRP group reached a final follow-up of 24 months. Five participants (5 hips, 36%) in the HA group reached a final follow-up of 24 months.
The Non Arthritic Hip subjective score is reported for both groups of treatment as the change from baseline to 24 months post-injection. The maximum score is 100 indicating normal hip function.
Outcome measures
| Measure |
Autologous PRP Hip Injection
n=15 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=5 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Change in Non-Arthritic Hip Score
|
6.09 score on a scale
Standard Deviation 23.97
|
-7.26 score on a scale
Standard Deviation 15.97
|
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Fourteen participants (15 hips, 74%) in the PRP group reached a final follow-up of 24 months. Five participants (5 hips, 36%) in the HA group reached a final follow-up of 24 months.
The flexion-abduction-external rotation (FABER) test is a clinical test utilized as a provocation test to detect hip, lumbar spine, or sacroiliac joint pathology. A positive FABER test is one that reproduces the patient's pain or limits their range of movement, while a negative FABER test is one that does not reproduce the patient's pain or limit their range of movement. The FABER test is reported for both groups of treatment as count of hips experiencing a decrease in pain (from a positive test to a negative test) during the FABER test from baseline to 24 months.
Outcome measures
| Measure |
Autologous PRP Hip Injection
n=15 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=5 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Change in Flexion-Abduction-External Rotation (FABER) Test.
|
7 Hips
|
3 Hips
|
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Fourteen participants (15 hips, 74%) in the PRP group reached a final follow-up of 24 months. Five participants (5 hips, 36%) in the HA group reached a final follow-up of 24 months.
Anterior posterior hip x-rays were performed for each hip and classified according to Kellgren-Lawrence (KL) grading scale, which is defined as follows: 0 = normal; 1 = doubtful narrowing of joint space and possible osteophytic lipping; 2 = definite osteophytes and possible narrowing of joint space; 3 = moderate multiple osteophytes, definite narrowing of joint space, some sclerosis, and possible deformity of bone contour; 4 = large osteophytes, marked narrowing of joint space, severe sclerosis, and definite deformity of bone contour. The Kellgren-Lawrence (KL) Grading Scale is reported for both groups of treatment as the change from baseline to 24 months.
Outcome measures
| Measure |
Autologous PRP Hip Injection
n=15 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.
PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
|
Hyaluronic Acid Hip Injection
n=5 Hips
Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.
Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
|
|---|---|---|
|
Change in Anterior Posterior (AP) Pelvis Radiograph/ Kellgren-Lawrence Grading Scale Classification.
|
0.5 score on a scale
Standard Deviation 0.6
|
0.6 score on a scale
Standard Deviation 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 2-Week 3 and 6-12-18-24 monthsType, duration and trend of every adverse event for each patient will be reported
Outcome measures
Outcome data not reported
Adverse Events
Autologous PRP Hip Injection
Hyaluronic Acid Hip Injection
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place