Trial Outcomes & Findings for SCP Hip Outcomes Study (NCT NCT03494660)
NCT ID: NCT03494660
Last Updated: 2026-04-21
Results Overview
Change in Modified Harris Hip Score using a 0-100 overall score, from baseline at 2-years. Subscales of pain, function, and activity levels are combined to generate the overall score. Pain is scored out of 44 possible points, function is scored out of 33 possible points and subject activities are scored out of 14 possible points. The maximum score of 91 is multiplied by 1.1 to give a total score out of 100; a higher score represents better patient reported pain, function and activity levels.
COMPLETED
77 participants
2 Years
2026-04-21
Participant Flow
Participant milestones
| Measure |
Subchondroplasty Using AccuFill®
Participants underwent the subchondroplasty (SCP) procedure using AccuFill® bone substitute material. Per the Instructions for Use (IFU), the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Overall Study
STARTED
|
77
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Subchondroplasty Using AccuFill®
Participants underwent the subchondroplasty (SCP) procedure using AccuFill® bone substitute material. Per the Instructions for Use (IFU), the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
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|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Surgical Reoperation
|
12
|
Baseline Characteristics
The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
Baseline characteristics by cohort
| Measure |
Subchondroplasty Using AccuFill®
n=77 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=77 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=77 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=77 Participants
|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 12 • n=77 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=77 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=77 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=77 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=77 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=77 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=77 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=77 Participants
|
|
Modified Harris Hip Score (mHHS)
All Subjects
|
55.0 Points (0-100 scale)
STANDARD_DEVIATION 20.6 • n=70 Participants • The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
|
|
Modified Harris Hip Score (mHHS)
On-Label Subjects
|
55.5 Points (0-100 scale)
STANDARD_DEVIATION 20.2 • n=52 Participants • The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
|
|
Modified Harris Hip Score (mHHS)
Off-Label Subjects
|
53.4 Points (0-100 scale)
STANDARD_DEVIATION 22.2 • n=18 Participants • The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
|
|
Numeric Pain Scale (NPS)
All Subjects
|
5.9 Score on a scale
STANDARD_DEVIATION 2.6 • n=76 Participants • The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
|
|
Numeric Pain Scale (NPS)
On-Label Subjects
|
5.8 Score on a scale
STANDARD_DEVIATION 2.7 • n=58 Participants • The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
|
|
Numeric Pain Scale (NPS)
Off-Label
|
6.4 Score on a scale
STANDARD_DEVIATION 2.5 • n=18 Participants • The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
|
|
EQ-5D-5L Index Score
All subjects
|
0.2 Index Score
STANDARD_DEVIATION 0.4 • n=70 Participants • The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
|
|
EQ-5D-5L Index Score
On-Label Subjects
|
0.2 Index Score
STANDARD_DEVIATION 0.4 • n=52 Participants • The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
|
|
EQ-5D-5L Index Score
Off-Label Subjects
|
0.3 Index Score
STANDARD_DEVIATION 0.4 • n=18 Participants • The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
|
|
EQ-5D-5L Visual Analog Scale (VAS)
All Subjects
|
67.4 Score (0-100) on a scale
STANDARD_DEVIATION 22.5 • n=70 Participants • The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
|
|
EQ-5D-5L Visual Analog Scale (VAS)
On-Label Subjects
|
66.9 Score (0-100) on a scale
STANDARD_DEVIATION 21.9 • n=52 Participants • The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
|
|
EQ-5D-5L Visual Analog Scale (VAS)
Off-Label Subjects
|
68.7 Score (0-100) on a scale
STANDARD_DEVIATION 24.7 • n=18 Participants • The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
|
PRIMARY outcome
Timeframe: 2 YearsPopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure.
Change in Modified Harris Hip Score using a 0-100 overall score, from baseline at 2-years. Subscales of pain, function, and activity levels are combined to generate the overall score. Pain is scored out of 44 possible points, function is scored out of 33 possible points and subject activities are scored out of 14 possible points. The maximum score of 91 is multiplied by 1.1 to give a total score out of 100; a higher score represents better patient reported pain, function and activity levels.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=77 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Overall Group Mean Improvement From Baseline of the Modified Harris Hip Score (mHHS) at 2 Years
All participants
|
25.8 score on a scale
Standard Deviation 19.4
|
|
Overall Group Mean Improvement From Baseline of the Modified Harris Hip Score (mHHS) at 2 Years
On-Label
|
26.3 score on a scale
Standard Deviation 17.1
|
|
Overall Group Mean Improvement From Baseline of the Modified Harris Hip Score (mHHS) at 2 Years
Off-Label
|
24.8 score on a scale
Standard Deviation 24.5
|
SECONDARY outcome
Timeframe: 2 weeks postoperativePopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure.
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=75 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
All participants
|
2.9 score on a scale
Standard Deviation 2.7
|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
On-label
|
3.0 score on a scale
Standard Deviation 2.8
|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
Off-label
|
2.8 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 6 weeks postoperativePopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure.
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=71 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
All participants
|
3.1 score on a scale
Standard Deviation 2.3
|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
On-label
|
3.8 score on a scale
Standard Deviation 2.5
|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
Off-label
|
3.2 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 12 weeks postoperativePopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure.
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=66 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
All participants
|
2.9 score on a scale
Standard Deviation 2.3
|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
On-label
|
2.9 score on a scale
Standard Deviation 2.4
|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
Off-label
|
2.7 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 6 months postoperativePopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure.
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=65 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
All participants
|
3.0 score on a scale
Standard Deviation 2.6
|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
On-label
|
2.9 score on a scale
Standard Deviation 2.7
|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
Off-label
|
3.4 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 1 year postoperativePopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure.
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=54 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
All participants
|
2.9 score on a scale
Standard Deviation 2.8
|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
On-label
|
3.0 score on a scale
Standard Deviation 2.8
|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
Off-label
|
2.3 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 2 years postoperativePopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure.
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=45 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
All participants
|
2.7 score on a scale
Standard Deviation 2.5
|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
On-label
|
2.8 score on a scale
Standard Deviation 2.4
|
|
Pain and Functional Performance by Numeric Pain Scale (NPS)
Off-label
|
2.6 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 6 weeks postoperativePopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure.
Hip function and pain were assessed using the Modified Harris Hip Score (mHHS), a validated instrument that evaluates pain, daily activities, and gait. Scores range from 0 to 100, where higher scores indicate better hip function and less pain. Change from baseline was calculated at each follow-up timepoint.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=69 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Modified Harris Hip Score (mHHS)
Aggregate Participants
|
68.1 Score in points
Standard Deviation 20.5
|
|
Modified Harris Hip Score (mHHS)
On-Label
|
69.2 Score in points
Standard Deviation 20.8
|
|
Modified Harris Hip Score (mHHS)
Off-Label
|
64.4 Score in points
Standard Deviation 19.5
|
SECONDARY outcome
Timeframe: 12 weeks postoperativePopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure.
Hip function and pain were assessed using the Modified Harris Hip Score (mHHS), a validated instrument that evaluates pain, daily activities, and gait. Scores range from 0 to 100, where higher scores indicate better hip function and less pain. Change from baseline was calculated at each follow-up timepoint.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=66 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Modified Harris Hip Score (mHHS)
Aggregate Participants
|
77.8 Score in points
Standard Deviation 18.3
|
|
Modified Harris Hip Score (mHHS)
On-Label
|
78.1 Score in points
Standard Deviation 19.1
|
|
Modified Harris Hip Score (mHHS)
Off-Label
|
76.3 Score in points
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: 6 months postoperativePopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure.
Hip function and pain were assessed using the Modified Harris Hip Score (mHHS), a validated instrument that evaluates pain, daily activities, and gait. Scores range from 0 to 100, where higher scores indicate better hip function and less pain. Change from baseline was calculated at each follow-up timepoint.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=65 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Modified Harris Hip Score (mHHS)
Aggregate Participants
|
76.0 Score in points
Standard Deviation 22.4
|
|
Modified Harris Hip Score (mHHS)
On-label
|
77.2 Score in points
Standard Deviation 22.8
|
|
Modified Harris Hip Score (mHHS)
Off-label
|
72.3 Score in points
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: 1 year postoperativePopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure.
Hip function and pain were assessed using the Modified Harris Hip Score (mHHS), a validated instrument that evaluates pain, daily activities, and gait. Scores range from 0 to 100, where higher scores indicate better hip function and less pain. Change from baseline was calculated at each follow-up timepoint.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=53 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Modified Harris Hip Score (mHHS)
Aggregate Participants
|
77.0 Score in points
Standard Deviation 24.4
|
|
Modified Harris Hip Score (mHHS)
On-Label
|
75.9 Score in points
Standard Deviation 25.2
|
|
Modified Harris Hip Score (mHHS)
Off-Label
|
80.3 Score in points
Standard Deviation 22.3
|
SECONDARY outcome
Timeframe: 2 years postoperativePopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
Hip function and pain were assessed using the Modified Harris Hip Score (mHHS), a validated instrument that evaluates pain, daily activities, and gait. Scores range from 0 to 100, where higher scores indicate better hip function and less pain. Change from baseline was calculated at each follow-up timepoint.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=45 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Modified Harris Hip Score (mHHS)
Aggregate Participants
|
82.5 Score in points
Standard Deviation 17.8
|
|
Modified Harris Hip Score (mHHS)
On-Label
|
83.8 Score in points
Standard Deviation 17.3
|
|
Modified Harris Hip Score (mHHS)
Off-Label
|
79.4 Score in points
Standard Deviation 19.1
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
Quality of life will be assessed using the EQ-5D-5L questionnaire, which evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity. Responses will be converted into a single utility index score using the appropriate value set, with values typically ranging from 0 (worst health) to 1 (best health). Higher scores indicate better quality of life.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=69 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Subject Quality-of-life Measured by the EQ-5D-5L Score
Aggregate Participants
|
0.4 Index score
Standard Deviation 0.4
|
|
Subject Quality-of-life Measured by the EQ-5D-5L Score
On-Label Subjects
|
0.4 Index score
Standard Deviation 0.4
|
|
Subject Quality-of-life Measured by the EQ-5D-5L Score
Off-Label Subjects
|
0.3 Index score
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
Quality of life will be assessed using the EQ-5D-5L questionnaire, which evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity. Responses will be converted into a single utility index score using the appropriate value set, with values typically ranging from 0 (worst health) to 1 (best health). Higher scores indicate better quality of life.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=66 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Subject Quality-of-life Measured by the EQ-5D-5L Score
Aggregate Participants
|
0.5 Index score
Standard Deviation 0.4
|
|
Subject Quality-of-life Measured by the EQ-5D-5L Score
On-Label Subjects
|
0.5 Index score
Standard Deviation 0.4
|
|
Subject Quality-of-life Measured by the EQ-5D-5L Score
Off-Label Subjects
|
0.4 Index score
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
Quality of life will be assessed using the EQ-5D-5L questionnaire, which evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity. Responses will be converted into a single utility index score using the appropriate value set, with values typically ranging from 0 (worst health) to 1 (best health). Higher scores indicate better quality of life.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=66 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Subject Quality-of-life Measured by the EQ-5D-5L Score
Aggregate Participants
|
0.5 Index score
Standard Deviation 0.4
|
|
Subject Quality-of-life Measured by the EQ-5D-5L Score
On-Label Subjects
|
0.5 Index score
Standard Deviation 0.4
|
|
Subject Quality-of-life Measured by the EQ-5D-5L Score
Off-Label Subjects
|
0.3 Index score
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 1 YearPopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
Quality of life will be assessed using the EQ-5D-5L questionnaire, which evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity. Responses will be converted into a single utility index score using the appropriate value set, with values typically ranging from 0 (worst health) to 1 (best health). Higher scores indicate better quality of life.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=54 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Subject Quality-of-life Measured by the EQ-5D-5L Score
Aggregate Participants
|
0.5 Index score
Standard Deviation 0.4
|
|
Subject Quality-of-life Measured by the EQ-5D-5L Score
On-Label Subjects
|
0.5 Index score
Standard Deviation 0.4
|
|
Subject Quality-of-life Measured by the EQ-5D-5L Score
Off-Label Subjects
|
0.5 Index score
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure
Quality of life will be assessed using the EQ-5D-5L questionnaire, which evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity. Responses will be converted into a single utility index score using the appropriate value set, with values typically ranging from 0 (worst health) to 1 (best health). Higher scores indicate better quality of life.
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=46 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Subject Quality-of-life Measured by the EQ-5D-5L Score
Aggregate Participants
|
0.5 Index score
Standard Deviation 0.5
|
|
Subject Quality-of-life Measured by the EQ-5D-5L Score
On-Label Subjects
|
0.5 Index score
Standard Deviation 0.5
|
|
Subject Quality-of-life Measured by the EQ-5D-5L Score
Off-Label Subjects
|
0.5 Index score
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 6 WeeksPopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure.
The EQ-5D-5L VAS records the subject's self-rated health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=69 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
Aggregate Participants
|
71.3 Score (0-100) on a scale
Standard Deviation 19.2
|
|
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
On-Label Subjects
|
70.0 Score (0-100) on a scale
Standard Deviation 20.1
|
|
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
Off-Label Subjects
|
75.8 Score (0-100) on a scale
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure.
The EQ-5D-5L VAS records the subject's self-rated health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=66 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
Aggregate Participants
|
79.1 Score (0-100) on a scale
Standard Deviation 13.9
|
|
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
On-Label Subjects
|
79.1 Score (0-100) on a scale
Standard Deviation 14.5
|
|
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
Off-Label Subjects
|
79.0 Score (0-100) on a scale
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure.
The EQ-5D-5L VAS records the subject's self-rated health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=66 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
Aggregate Participants
|
75.6 Score (0-100) on a scale
Standard Deviation 17.4
|
|
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
On-Label Subjects
|
75.9 Score (0-100) on a scale
Standard Deviation 17.4
|
|
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
Off-Label Subjects
|
74.6 Score (0-100) on a scale
Standard Deviation 17.8
|
SECONDARY outcome
Timeframe: 1 YearPopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure.
The EQ-5D-5L VAS records the subject's self-rated health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=54 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
Aggregate Participants
|
79.3 Score (0-100) on a scale
Standard Deviation 19.5
|
|
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
On-Label Subjects
|
78.7 Score (0-100) on a scale
Standard Deviation 18.8
|
|
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
Off-Label Subjects
|
81.3 Score (0-100) on a scale
Standard Deviation 21.9
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: The number analyzed is lower than the number enrolled because analyses included only participants with available and complete survey data for the relevant outcome measure.
The EQ-5D-5L VAS records the subject's self-rated health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Outcome measures
| Measure |
Subchondroplasty Using AccuFill®
n=46 Participants
Participants underwent the SCP procedure using AccuFill® bone substitute material. Per the IFU, the material was intended to be mixed with blood or saline; however, some participants unintentionally received off-label treatment where AccuFill® was mixed with other materials (e.g., bone marrow aspirate concentrate). All participants were analyzed together for the primary and secondary endpoints, with subgroup analyses planned for on-label and off-label treatments.
|
|---|---|
|
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
On-Label Subjects
|
79.2 Score (0-100) on a scale
Standard Deviation 17.8
|
|
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
Aggregate Participants
|
80.2 Score (0-100) on a scale
Standard Deviation 16.5
|
|
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
Off-Label Subjects
|
82.5 Score (0-100) on a scale
Standard Deviation 13.2
|
Adverse Events
Subchondroplasty Using AccuFill® (On-Label)
Subchondroplasty Using AccuFill® (Off-Label)
Serious adverse events
| Measure |
Subchondroplasty Using AccuFill® (On-Label)
n=59 participants at risk
Participants underwent the SCP procedure using AccuFill® bone substitute material prepared in accordance with the IFU, with AccuFill® mixed with blood or saline.
|
Subchondroplasty Using AccuFill® (Off-Label)
n=18 participants at risk
Participants underwent the SCP procedure using AccuFill® bone substitute material prepared outside the IFU, with AccuFill® mixed with other materials (e.g., bone marrow aspirate concentrate).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hospitalilzation for back pain
|
1.7%
1/59 • Number of events 3 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
0.00%
0/18 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Psychiatric disorders
Hospitalilzation for psychosis
|
3.4%
2/59 • Number of events 2 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
0.00%
0/18 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Musculoskeletal and connective tissue disorders
Worsening arthralgias
|
1.7%
1/59 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
0.00%
0/18 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Musculoskeletal and connective tissue disorders
Hospital admission for post-operative pain
|
1.7%
1/59 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
0.00%
0/18 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Musculoskeletal and connective tissue disorders
Femoral head collapse resulting in total hip arthroplasty
|
1.7%
1/59 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
0.00%
0/18 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Musculoskeletal and connective tissue disorders
Increased pain from left hip avascular necrosis
|
0.00%
0/59 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Musculoskeletal and connective tissue disorders
Worsening/progression of osteoarthritis
|
3.4%
2/59 • Number of events 2 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
0.00%
0/18 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Musculoskeletal and connective tissue disorders
Right hip labrum tear, avascular necrosis and femoroacetabular impingement
|
0.00%
0/59 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Musculoskeletal and connective tissue disorders
Left sports hernia
|
0.00%
0/59 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalilzation for asthma exacerbation
|
1.7%
1/59 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
0.00%
0/18 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Nervous system disorders
Hospitalilzation for migrainous attack
|
1.7%
1/59 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
0.00%
0/18 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalilzation for COVID-19
|
1.7%
1/59 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
0.00%
0/18 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Musculoskeletal and connective tissue disorders
Increased pain from left hip osteoarthritis
|
0.00%
0/59 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Musculoskeletal and connective tissue disorders
Hip degenerative joint disease/osteoarthritis
|
3.4%
2/59 • Number of events 2 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Musculoskeletal and connective tissue disorders
Hip avascular necrosis
|
3.4%
2/59 • Number of events 2 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
0.00%
0/18 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Musculoskeletal and connective tissue disorders
Torn labrum
|
0.00%
0/59 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Musculoskeletal and connective tissue disorders
Left hip pain
|
1.7%
1/59 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
0.00%
0/18 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
Other adverse events
| Measure |
Subchondroplasty Using AccuFill® (On-Label)
n=59 participants at risk
Participants underwent the SCP procedure using AccuFill® bone substitute material prepared in accordance with the IFU, with AccuFill® mixed with blood or saline.
|
Subchondroplasty Using AccuFill® (Off-Label)
n=18 participants at risk
Participants underwent the SCP procedure using AccuFill® bone substitute material prepared outside the IFU, with AccuFill® mixed with other materials (e.g., bone marrow aspirate concentrate).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Increase in Left Hip Pain
|
0.00%
0/59 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Renal and urinary disorders
Postoperative urinary retention
|
1.7%
1/59 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
0.00%
0/18 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
1.7%
1/59 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
0.00%
0/18 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
|
Injury, poisoning and procedural complications
Delayed hardening of SCP material and prolonged extravasation from bone
|
0.00%
0/59 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60