An observational study in Subchondral Cysts, Subchondral Bone Edema and Bone Marrow Edema, sponsored by Zimmer Biomet. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Zimmer Biomet · Observational
Post-market clinical outcomes study to collect data on the short- and long-term outcomes for subjects who are undergoing or have undergone the Subchondroplasty® (SCP®) Procedure in the hip in a standard clinical setting. Outcomes to be assessed include medication usage, pain, function, activity levels and patient satisfaction.
This study is designed as a post-market, single arm, non-randomized multi-center investigation.
Male and female subjects, at least 18 years of age, with at least one subchondral bone defect in the form of a cyst and/or bone marrow lesion (BML), insufficiency fracture or bone defect associated with early stage avascular osteonecrosis (AVN) in the femoral head, femoral neck and/or acetabulum who are suitable candidates for use of AccuFill during the Subchondroplasty Procedure are eligible for enrollment in this study.
A maximum of 15 study sites, in the United States of America, will enroll a target of 50 subjects.
Each Investigator must obtain IRB approval, or favorable opinion by an EC, prior to consent of the first subject; no study-related procedures can occur without the approval and oversight of a registered IRB or EC. If the study site does not have an IRB of record, a central IRB may be utilized upon approval by Zimmer Biomet.
Demographics, medical history, hip history and use of pain medication and therapy will be recorded at the time of subject consent. Additionally, patient reported outcomes measures will be obtained pre-operatively. Operative details including the SCP Procedure, concomitant surgical procedures and intraoperative safety events will be recorded at the time of surgery. Prospective subjects will be considered enrolled in this study once their Subchondroplasty Procedure has been performed.
Subjects will complete only the Numeric Pain Scale at 2 weeks post-operatively. Thereafter, subjects will complete self-reported outcomes measures post-operatively at 6 weeks, 12 weeks, 6 months, 1 year and 2 years. These measures include information on pain medication and therapy, pain levels, function, activity and subject satisfaction. Screening for adverse events and conversion will occur throughout the study.
Subjects will complete the study at 2 years or will be withdrawn if they undergo conversion of the Subchondroplasty site. For the purposes of this protocol, a conversion will be defined as total hip arthroplasty or any procedure involving removal of the AccuFill material on the index hip.
18 studies on the registry are indexed under Bone Cysts; 5 are open to participants now.
Browse Bone Cysts studies →Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Approximately 50 subjects, each with at least one subchondral bone defect in the form of a cyst and/or bone marrow lesion (BML), insufficiency fracture or bone defect associated with early stage avascular osteonecrosis (AVN) in the femoral head, femoral neck and/or acetabulum who are suitable candidates for use of AccuFill during the Subchondroplasty Procedure are eligible for enrollment in this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Candidates must meet ALL of the following:
Exclusion Criteria:
Candidates will be excluded if they meet ANY of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Injection of the commercially available flowable calcium phosphate (CaP) synthetic bone-void filler, AccuFill®, into subchondral bone defects in the hip (Subchondroplasty (SCP) Procedure).
Overall Group Mean Improvement From Baseline of the Modified Harris Hip Score (mHHS) at 2 Years
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.
Time frame: 2 Years
Pain and Functional Performance by Numeric Pain Scale (NPS)
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Time frame: 2 weeks postoperative
Pain and Functional Performance by Numeric Pain Scale (NPS)
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Time frame: 6 weeks postoperative
Pain and Functional Performance by Numeric Pain Scale (NPS)
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Time frame: 12 weeks postoperative
Pain and Functional Performance by Numeric Pain Scale (NPS)
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Time frame: 6 months postoperative
Pain and Functional Performance by Numeric Pain Scale (NPS)
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Time frame: 1 year postoperative
Pain and Functional Performance by Numeric Pain Scale (NPS)
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Time frame: 2 years postoperative
Modified Harris Hip Score (mHHS)
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.
Time frame: 6 weeks postoperative
Modified Harris Hip Score (mHHS)
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.
Time frame: 12 weeks postoperative
Modified Harris Hip Score (mHHS)
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.
Time frame: 6 months postoperative
Modified Harris Hip Score (mHHS)
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.
Time frame: 1 year postoperative
Modified Harris Hip Score (mHHS)
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.
Time frame: 2 years postoperative
Subject Quality-of-life Measured by the EQ-5D-5L Score
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.
Time frame: 6 weeks
Subject Quality-of-life Measured by the EQ-5D-5L Score
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.
Time frame: 12 weeks
Subject Quality-of-life Measured by the EQ-5D-5L Score
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.
Time frame: 6 months
Subject Quality-of-life Measured by the EQ-5D-5L Score
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.
Time frame: 1 Year
Subject Quality-of-life Measured by the EQ-5D-5L Score
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.
Time frame: 2 Years
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
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).
Time frame: 6 Weeks
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
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).
Time frame: 12 Weeks
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
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).
Time frame: 6 Months
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
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).
Time frame: 1 Year
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
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).
Time frame: 2 Years
| Milestone | Subchondroplasty Using AccuFill® |
|---|---|
| Started | 77 |
| Completed | 50 |
| Not completed | 27 |
| Withdrew: Lost to follow-up | 13 |
| Withdrew: Physician decision | 2 |
| Withdrew: Surgical reoperation | 12 |
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.
| score on a scale | Subchondroplasty Using AccuFill® |
|---|---|
| All participants | 25.8 ± 19.4 |
| On-Label | 26.3 ± 17.1 |
| Off-Label | 24.8 ± 24.5 |
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
| score on a scale | Subchondroplasty Using AccuFill® |
|---|---|
| All participants | 2.9 ± 2.7 |
| On-label | 3.0 ± 2.8 |
| Off-label | 2.8 ± 2.4 |
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
| score on a scale | Subchondroplasty Using AccuFill® |
|---|---|
| All participants | 3.1 ± 2.3 |
| On-label | 3.8 ± 2.5 |
| Off-label | 3.2 ± 2.3 |
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
| score on a scale | Subchondroplasty Using AccuFill® |
|---|---|
| All participants | 2.9 ± 2.3 |
| On-label | 2.9 ± 2.4 |
| Off-label | 2.7 ± 2.0 |
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
| score on a scale | Subchondroplasty Using AccuFill® |
|---|---|
| All participants | 3.0 ± 2.6 |
| On-label | 2.9 ± 2.7 |
| Off-label | 3.4 ± 2.4 |
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
| score on a scale | Subchondroplasty Using AccuFill® |
|---|---|
| All participants | 2.9 ± 2.8 |
| On-label | 3.0 ± 2.8 |
| Off-label | 2.3 ± 2.8 |
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
| score on a scale | Subchondroplasty Using AccuFill® |
|---|---|
| All participants | 2.7 ± 2.5 |
| On-label | 2.8 ± 2.4 |
| Off-label | 2.6 ± 2.8 |
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.
| Score in points | Subchondroplasty Using AccuFill® |
|---|---|
| Aggregate Participants | 68.1 ± 20.5 |
| On-Label | 69.2 ± 20.8 |
| Off-Label | 64.4 ± 19.5 |
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.
| Score in points | Subchondroplasty Using AccuFill® |
|---|---|
| Aggregate Participants | 77.8 ± 18.3 |
| On-Label | 78.1 ± 19.1 |
| Off-Label | 76.3 ± 14.7 |
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.
| Score in points | Subchondroplasty Using AccuFill |
|---|---|
| Aggregate Participants | 76.0 ± 22.4 |
| On-label | 77.2 ± 22.8 |
| Off-label | 72.3 ± 21.5 |
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.
| Score in points | Subchondroplasty Using AccuFill |
|---|---|
| Aggregate Participants | 77.0 ± 24.4 |
| On-Label | 75.9 ± 25.2 |
| Off-Label | 80.3 ± 22.3 |
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.
| Score in points | Subchondroplasty Using AccuFill |
|---|---|
| Aggregate Participants | 82.5 ± 17.8 |
| On-Label | 83.8 ± 17.3 |
| Off-Label | 79.4 ± 19.1 |
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.
| Index score | Subchondroplasty Using AccuFill |
|---|---|
| Aggregate Participants | 0.4 ± 0.4 |
| On-Label Subjects | 0.4 ± 0.4 |
| Off-Label Subjects | 0.3 ± 0.4 |
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.
| Index score | Subchondroplasty Using AccuFill |
|---|---|
| Aggregate Participants | 0.5 ± 0.4 |
| On-Label Subjects | 0.5 ± 0.4 |
| Off-Label Subjects | 0.4 ± 0.4 |
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.
| Index score | Subchondroplasty Using AccuFill |
|---|---|
| Aggregate Participants | 0.5 ± 0.4 |
| On-Label Subjects | 0.5 ± 0.4 |
| Off-Label Subjects | 0.3 ± 0.5 |
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.
| Index score | Subchondroplasty Using AccuFill |
|---|---|
| Aggregate Participants | 0.5 ± 0.4 |
| On-Label Subjects | 0.5 ± 0.4 |
| Off-Label Subjects | 0.5 ± 0.5 |
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.
| Index score | Subchondroplasty Using AccuFill |
|---|---|
| Aggregate Participants | 0.5 ± 0.5 |
| On-Label Subjects | 0.5 ± 0.5 |
| Off-Label Subjects | 0.5 ± 0.5 |
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).
| Score (0-100) on a scale | Subchondroplasty Using AccuFill |
|---|---|
| Aggregate Participants | 71.3 ± 19.2 |
| On-Label Subjects | 70.0 ± 20.1 |
| Off-Label Subjects | 75.8 ± 15.8 |
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).
| Score (0-100) on a scale | Subchondroplasty Using AccuFill |
|---|---|
| Aggregate Participants | 79.1 ± 13.9 |
| On-Label Subjects | 79.1 ± 14.5 |
| Off-Label Subjects | 79.0 ± 11.3 |
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).
| Score (0-100) on a scale | Subchondroplasty Using AccuFill |
|---|---|
| Aggregate Participants | 75.6 ± 17.4 |
| On-Label Subjects | 75.9 ± 17.4 |
| Off-Label Subjects | 74.6 ± 17.8 |
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).
| Score (0-100) on a scale | Subchondroplasty Using AccuFill |
|---|---|
| Aggregate Participants | 79.3 ± 19.5 |
| On-Label Subjects | 78.7 ± 18.8 |
| Off-Label Subjects | 81.3 ± 21.9 |
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).
| Score (0-100) on a scale | Subchondroplasty Using AccuFill |
|---|---|
| Aggregate Participants | 80.2 ± 16.5 |
| On-Label Subjects | 79.2 ± 17.8 |
| Off-Label Subjects | 82.5 ± 13.2 |
Collected over Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subchondroplasty Using AccuFill® (On-Label) | 0/59 (0%) | 11/59 (18.6%) | 2/59 (3.4%) |
| Subchondroplasty Using AccuFill® (Off-Label) | 0/18 (0%) | 4/18 (22.2%) | 2/18 (11.1%) |
| Event | Subchondroplasty Using AccuFill® (On-Label) | Subchondroplasty Using AccuFill® (Off-Label) |
|---|---|---|
| Increased pain from left hip osteoarthritisMusculoskeletal and connective tissue disorders | 0/59 | 1/18 |
| Hip degenerative joint disease/osteoarthritisMusculoskeletal and connective tissue disorders | 2/59 | 1/18 |
| Torn labrumMusculoskeletal and connective tissue disorders | 0/59 | 1/18 |
| Left sports herniaMusculoskeletal and connective tissue disorders | 0/59 | 1/18 |
| Increased pain from left hip avascular necrosisMusculoskeletal and connective tissue disorders | 0/59 | 1/18 |
| Right hip labrum tear, avascular necrosis and femoroacetabular impingementMusculoskeletal and connective tissue disorders | 0/59 | 1/18 |
| Hip avascular necrosisMusculoskeletal and connective tissue disorders | 2/59 | 0/18 |
| Hospitalilzation for psychosisPsychiatric disorders | 2/59 | 0/18 |
| Worsening/progression of osteoarthritisMusculoskeletal and connective tissue disorders | 2/59 | 0/18 |
| Left hip painMusculoskeletal and connective tissue disorders | 1/59 | 0/18 |
| Event | Subchondroplasty Using AccuFill® (On-Label) | Subchondroplasty Using AccuFill® (Off-Label) |
|---|---|---|
| Increase in Left Hip PainMusculoskeletal and connective tissue disorders | 0/59 | 1/18 |
| Delayed hardening of SCP material and prolonged extravasation from boneInjury, poisoning and procedural complications | 0/59 | 1/18 |
| Postoperative urinary retentionRenal and urinary disorders | 1/59 | 0/18 |
| Lung CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/59 | 0/18 |
Baseline characteristics are reported for all enrolled participants. Subgroup analyses (on-label vs off-label) are presented in outcome measures.
| Age, Categorical(Participants) | Subchondroplasty Using AccuFill® |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 75 |
| >=65 years | 2 |
| Age, Continuous(years) | Subchondroplasty Using AccuFill® |
|---|---|
| Mean | 41.5 ± 12 |
| Sex: Female, Male(Participants) | Subchondroplasty Using AccuFill® |
|---|---|
| Female | 27 |
| Male | 50 |
| Ethnicity (NIH/OMB)(Participants) | Subchondroplasty Using AccuFill® |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 76 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Subchondroplasty Using AccuFill® |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 15 |
| White | 61 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Modified Harris Hip Score (mHHS)(Points (0-100 scale)) | Subchondroplasty Using AccuFill® |
|---|---|
| All Subjects | 55.0 ± 20.6 |
| On-Label Subjects | 55.5 ± 20.2 |
| Off-Label Subjects | 53.4 ± 22.2 |
| Numeric Pain Scale (NPS)(Score on a scale) | Subchondroplasty Using AccuFill® |
|---|---|
| All Subjects | 5.9 ± 2.6 |
| On-Label Subjects | 5.8 ± 2.7 |
| Off-Label | 6.4 ± 2.5 |
| EQ-5D-5L Index Score(Index Score) | Subchondroplasty Using AccuFill® |
|---|---|
| All subjects | 0.2 ± 0.4 |
| On-Label Subjects | 0.2 ± 0.4 |
| Off-Label Subjects | 0.3 ± 0.4 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Oct 2023, 66 months.
Results were first posted in Apr 2026, 2 years 5 months after primary completion.
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