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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Subjects will complete the study at 2 years or will be withdrawn if they undergo conversion of the Subchondroplasty site.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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subchondroplasty Procedure with AccuFill | Device | Injection of the commercially available flowable calcium phosphate (CaP) synthetic bone-void filler, AccuFill®, into subchondral bone defects in the hip (Subchondroplasty (SCP) Procedure). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks postoperative |
| Pain and Functional Performance by Numeric Pain Scale (NPS) |
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Inclusion Criteria:
Candidates must meet ALL of the following:
Exclusion Criteria:
Candidates will be excluded if they meet ANY of the following:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisenhower Desert Orthopedic Center | Rancho Mirage | California | 92270 | United States | ||
| Andrews Research & Education Foundation |
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| Label | URL |
|---|---|
| The Subchondroplasty® (SCP®) Procedure | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics are reported for all enrolled participants. Subgroup analyses (on-label vs off-label) are presented in outcome measures.
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| ID | Title | Description |
|---|---|---|
| BG000 | Subchondroplasty Using AccuFill® | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 Years |
|
Adverse event data were collected for the operative, 2-week, 6-week, 12-week, 6 month, 1-year, and 2-year windows.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subchondroplasty Using AccuFill® (On-Label) | Participants underwent the SCP procedure using AccuFill® bone substitute material prepared in accordance with the IFU, with AccuFill® mixed with blood or saline. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased pain from left hip osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | SCP Related (Possibly, Probably or Definitely related); AccuFill Related (Possibly, Probably or Definitely) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase in Left Hip Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | SCP Related (Possibly, Probably or Definitely related); AccuFill Related (Possibly, Probably or Definitely) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annette Tieu | Zimmer Biomet | 971-482-9622 | annette.tieu@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2023 | Oct 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001845 | Bone Cysts |
| D015775 | Fractures, Stress |
| D057925 | Femoracetabular Impingement |
| D006617 | Hip Dislocation |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 2 Years |
| Gulf Breeze |
| Florida |
| 32561 |
| United States |
| OrthoIllinois | Rockford | Illinois | 61114 | United States |
| University of Kentucky Research Foundation | Lexington | Kentucky | 40506 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| The Ohio State University | Columbus | Ohio | 43202 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Modified Harris Hip Score (mHHS) | Modified Harris Hip Score is a validated instrument used to assess hip function, pain, and mobility. It consists of multiple components evaluating pain, daily activities, and gait, with a total score ranging from 0 to 100, where higher scores indicate better hip function. | 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 | Mean | Standard Deviation | Points (0-100 scale) |
|
| Numeric Pain Scale (NPS) | Subject rates pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable). | 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 | Mean | Standard Deviation | Score on a scale |
|
| EQ-5D-5L Index Score | The EQ-5D-5L Index Score is derived from responses to five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The index value is calculated using a country-specific valuation set (e.g., United States), typically ranging from 0 (worst health state) to 1 (best health state). | 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 | Mean | Standard Deviation | Index Score |
|
| 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). | 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 | Mean | Standard Deviation | Score (0-100) on a scale |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks postoperative |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks postoperative |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks postoperative |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months postoperative |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 year postoperative |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 years postoperative |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Score in points | 6 weeks postoperative |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Score in points | 12 weeks postoperative |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Score in points | 6 months postoperative |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Score in points | 1 year postoperative |
|
|
|
| Secondary | 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. | 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 | Posted | Mean | Standard Deviation | Score in points | 2 years postoperative |
|
|
|
| Secondary | 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. | 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 | Posted | Mean | Standard Deviation | Index score | 6 weeks |
|
|
|
| Secondary | 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. | 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 | Posted | Mean | Standard Deviation | Index score | 12 weeks |
|
|
|
| Secondary | 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. | 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 | Posted | Mean | Standard Deviation | Index score | 6 months |
|
|
|
| Secondary | 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. | 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 | Posted | Mean | Standard Deviation | Index score | 1 Year |
|
|
|
| Secondary | 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. | 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 | Posted | Mean | Standard Deviation | Index score | 2 Years |
|
|
|
| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | Score (0-100) on a scale | 6 Weeks |
|
|
|
| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | Score (0-100) on a scale | 12 Weeks |
|
|
|
| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | Score (0-100) on a scale | 6 Months |
|
|
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| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | Score (0-100) on a scale | 1 Year |
|
|
|
| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | Score (0-100) on a scale | 2 Years |
|
|
|
| 0 |
| 59 |
| 11 |
| 59 |
| 2 |
| 59 |
| EG001 | Subchondroplasty Using AccuFill® (Off-Label) | 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). | 0 | 18 | 4 | 18 | 2 | 18 |
|
| Hip degenerative joint disease/osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hip avascular necrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Torn labrum | Musculoskeletal and connective tissue disorders | Systematic Assessment | SCP (Possibly, Probably or Definitely related) |
|
| Left hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | SCP (Possibly, Probably or Definitely related); AccuFill Related (Possibly, Probably or Definitely) |
|
| Left sports hernia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hospitalilzation for asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hospitalilzation for migrainous attack | Nervous system disorders | Systematic Assessment |
|
| Hospitalilzation for COVID-19 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hospitalilzation for back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hospitalilzation for psychosis | Psychiatric disorders | Systematic Assessment |
|
| Worsening arthralgias | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hospital admission for post-operative pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | SCP Related (Possibly, Probably, or Definitely) |
|
| Femoral head collapse resulting in total hip arthroplasty | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Increased pain from left hip avascular necrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | SCP Related (Possibly, Probably or Definitely related); AccuFill Related (Possibly, Probably or Definitely) |
|
| Worsening/progression of osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Right hip labrum tear, avascular necrosis and femoroacetabular impingement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
|
| Postoperative urinary retention | Renal and urinary disorders | Systematic Assessment | SCP Related (Possibly, Probably, or Definitely) |
|
| Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Delayed hardening of SCP material and prolonged extravasation from bone | Injury, poisoning and procedural complications | Systematic Assessment | SCP Related (Possibly, Probably or Definitely related); AccuFill Related (Possibly, Probably or Definitely); Initially classified as non-serious, but ultimately required revision surgery |
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Not provided
| D050723 |
| Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007592 | Joint Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004204 | Joint Dislocations |
| D025981 | Hip Injuries |
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