Trial Outcomes & Findings for Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty (NCT NCT01525667)
NCT ID: NCT01525667
Last Updated: 2015-09-21
Results Overview
Change from Visit 2 (Day 0) to Week 26 in the maximal voluntary isometric contraction (MVIC) moment of the injured side as measured by isometric dynamometry to assess Gluteus Medius force strength.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Day 0 to Week 26
Results posted on
2015-09-21
Participant Flow
Participant milestones
| Measure |
PLX-PAD Low Dose
150M PLX-PAD : Single treatment, multiple injections
|
PLX-PAD High Dose
300M PLX-PAD : Single treatment, multiple injections
|
Placebo
Placebo: Single treatment, multiple injections
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
7
|
|
Overall Study
COMPLETED
|
7
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty
Baseline characteristics by cohort
| Measure |
PLX-PAD Low Dose
n=7 Participants
PLX-PAD low dose: Single treatment, multiple injections
|
PLX-PAD High Dose
n=6 Participants
PLX-PAD high dose: Single treatment, multiple injections
|
Placebo
n=7 Participants
Placebo: Single treatment, multiple injections
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
11 Participants
n=31 Participants
|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 5.9 • n=39 Participants
|
64.5 years
STANDARD_DEVIATION 7.4 • n=41 Participants
|
64.3 years
STANDARD_DEVIATION 6.4 • n=35 Participants
|
64.8 years
STANDARD_DEVIATION 6.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=39 Participants
|
6 participants
n=41 Participants
|
7 participants
n=35 Participants
|
20 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Week 26Change from Visit 2 (Day 0) to Week 26 in the maximal voluntary isometric contraction (MVIC) moment of the injured side as measured by isometric dynamometry to assess Gluteus Medius force strength.
Outcome measures
| Measure |
PLX-PAD Low Dose
n=7 Participants
PLX-PAD low dose: Single treatment, multiple injections
|
PLX-PAD High Dose
n=6 Participants
PLX-PAD high dose: Single treatment, multiple injections
|
Placebo
n=7 Participants
Placebo: Single treatment, multiple injections
|
|---|---|---|---|
|
Change From Day 0 to Week 26 in the Maximal Voluntary Isometric Contraction (MVIC) Moment of the Injured Side to Assess Gluteus Medius Strength.
|
31.17 Newtons
Standard Error 6.97
|
20.36 Newtons
Standard Error 7.61
|
5.43 Newtons
Standard Error 6.46
|
SECONDARY outcome
Timeframe: Day 0 to Week 26Change from Visit 2 (Day 0) to Week 26 in Muscle Volume as Measured by MRI.
Outcome measures
| Measure |
PLX-PAD Low Dose
n=7 Participants
PLX-PAD low dose: Single treatment, multiple injections
|
PLX-PAD High Dose
n=6 Participants
PLX-PAD high dose: Single treatment, multiple injections
|
Placebo
n=7 Participants
Placebo: Single treatment, multiple injections
|
|---|---|---|---|
|
Change From Day 0 to Week 26 in Muscle Volume.
|
24.42 mm3
Standard Error 4.18
|
15.62 mm3
Standard Error 4.91
|
6.39 mm3
Standard Error 4.35
|
SECONDARY outcome
Timeframe: Day 1 to Week 12Change from Visit 3 (Day 1) to Week 12 in Mean Fiber Diameter as Measured by Muscle Biopsy.
Outcome measures
| Measure |
PLX-PAD Low Dose
n=7 Participants
PLX-PAD low dose: Single treatment, multiple injections
|
PLX-PAD High Dose
n=6 Participants
PLX-PAD high dose: Single treatment, multiple injections
|
Placebo
n=7 Participants
Placebo: Single treatment, multiple injections
|
|---|---|---|---|
|
Change From Day 1 to Week 12 in Mean Fiber Diameter.
|
1.25 microns
Standard Error 3.27
|
0.28 microns
Standard Error 3.23
|
-5.21 microns
Standard Error 3.24
|
SECONDARY outcome
Timeframe: Day 0 to Week 26Change from Visit 2 (Day 0) to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift as Measured by Gait Analysis
Outcome measures
| Measure |
PLX-PAD Low Dose
n=7 Participants
PLX-PAD low dose: Single treatment, multiple injections
|
PLX-PAD High Dose
n=6 Participants
PLX-PAD high dose: Single treatment, multiple injections
|
Placebo
n=7 Participants
Placebo: Single treatment, multiple injections
|
|---|---|---|---|
|
Change From Day 0 to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift .
|
0.43 Ratio
Standard Error 0.13
|
0.28 Ratio
Standard Error 0.14
|
0.27 Ratio
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Day 0 to Week 26Visual Analog Scale (VAS) Pain Score ranges from 0 mm (no pain) to 100 mm (worse possible pain)
Outcome measures
| Measure |
PLX-PAD Low Dose
n=7 Participants
PLX-PAD low dose: Single treatment, multiple injections
|
PLX-PAD High Dose
n=6 Participants
PLX-PAD high dose: Single treatment, multiple injections
|
Placebo
n=7 Participants
Placebo: Single treatment, multiple injections
|
|---|---|---|---|
|
Change From Day 0 to Week 26 in the Visual Analog Scale (VAS) Pain Score.
|
-31.76 mm
Standard Error 5.90
|
-37.87 mm
Standard Error 6.53
|
-48.57 mm
Standard Error 5.97
|
Adverse Events
150M PLX-PAD
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
300M PLX-PAD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
150M PLX-PAD
n=7 participants at risk
PLX-PAD low dose: Single treatment, multiple injections
|
300M PLX-PAD
n=6 participants at risk
PLX-PAD high dose: Single treatment, multiple injections
|
Placebo
n=7 participants at risk
Placebo: Single treatment, multiple injections
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
HUMERAL HEAD FRACTURE
|
14.3%
1/7 • Number of events 1 • Data were collected for total period of 1 year.
|
0.00%
0/6 • Data were collected for total period of 1 year.
|
14.3%
1/7 • Number of events 1 • Data were collected for total period of 1 year.
|
|
Renal and urinary disorders
PERIURETHRAL CYST
|
0.00%
0/7 • Data were collected for total period of 1 year.
|
0.00%
0/6 • Data were collected for total period of 1 year.
|
14.3%
1/7 • Number of events 1 • Data were collected for total period of 1 year.
|
Other adverse events
| Measure |
150M PLX-PAD
n=7 participants at risk
PLX-PAD low dose: Single treatment, multiple injections
|
300M PLX-PAD
n=6 participants at risk
PLX-PAD high dose: Single treatment, multiple injections
|
Placebo
n=7 participants at risk
Placebo: Single treatment, multiple injections
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Breath odour
|
28.6%
2/7 • Number of events 2 • Data were collected for total period of 1 year.
|
16.7%
1/6 • Number of events 1 • Data were collected for total period of 1 year.
|
14.3%
1/7 • Number of events 1 • Data were collected for total period of 1 year.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
71.4%
5/7 • Number of events 7 • Data were collected for total period of 1 year.
|
50.0%
3/6 • Number of events 3 • Data were collected for total period of 1 year.
|
42.9%
3/7 • Number of events 4 • Data were collected for total period of 1 year.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • Data were collected for total period of 1 year.
|
16.7%
1/6 • Number of events 1 • Data were collected for total period of 1 year.
|
28.6%
2/7 • Number of events 2 • Data were collected for total period of 1 year.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
14.3%
1/7 • Number of events 1 • Data were collected for total period of 1 year.
|
0.00%
0/6 • Data were collected for total period of 1 year.
|
42.9%
3/7 • Number of events 3 • Data were collected for total period of 1 year.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
42.9%
3/7 • Number of events 3 • Data were collected for total period of 1 year.
|
50.0%
3/6 • Number of events 4 • Data were collected for total period of 1 year.
|
28.6%
2/7 • Number of events 4 • Data were collected for total period of 1 year.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
28.6%
2/7 • Number of events 2 • Data were collected for total period of 1 year.
|
0.00%
0/6 • Data were collected for total period of 1 year.
|
0.00%
0/7 • Data were collected for total period of 1 year.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Data were collected for total period of 1 year.
|
16.7%
1/6 • Number of events 2 • Data were collected for total period of 1 year.
|
14.3%
1/7 • Number of events 1 • Data were collected for total period of 1 year.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
28.6%
2/7 • Number of events 3 • Data were collected for total period of 1 year.
|
16.7%
1/6 • Number of events 1 • Data were collected for total period of 1 year.
|
0.00%
0/7 • Data were collected for total period of 1 year.
|
|
Nervous system disorders
Paraesthesia
|
28.6%
2/7 • Number of events 3 • Data were collected for total period of 1 year.
|
0.00%
0/6 • Data were collected for total period of 1 year.
|
14.3%
1/7 • Number of events 1 • Data were collected for total period of 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/7 • Data were collected for total period of 1 year.
|
33.3%
2/6 • Number of events 2 • Data were collected for total period of 1 year.
|
28.6%
2/7 • Number of events 2 • Data were collected for total period of 1 year.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/7 • Data were collected for total period of 1 year.
|
0.00%
0/6 • Data were collected for total period of 1 year.
|
28.6%
2/7 • Number of events 2 • Data were collected for total period of 1 year.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
28.6%
2/7 • Number of events 3 • Data were collected for total period of 1 year.
|
16.7%
1/6 • Number of events 1 • Data were collected for total period of 1 year.
|
28.6%
2/7 • Number of events 2 • Data were collected for total period of 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place