SCP Hip Outcomes Study

A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Hip

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.

Study Overview

• Status: Completed
• Conditions: Femoroacetabular Impingement; Avascular Necrosis of Hip; Bone Marrow Edema; Insufficiency Fractures; Subchondral Cysts; Subchondral Bone Edema; Dysplasia; Hip
• Intervention / Treatment: Device: Subchondroplasty Procedure with AccuFill

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• United States
  • California
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Desert Orthopedic Center
  • Florida
    • Gulf Breeze, Florida, United States, 32561
      • Andrews Research & Education Foundation
  • Illinois
    • Rockford, Illinois, United States, 61114
      • OrthoIllinois
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky Research Foundation
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43202
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Candidates must meet ALL of the following:

  1. Surgeon considers the patient appropriate for the SCP Procedure of the hip.
  2. Subchondral bone defect(s) in the femoral head, femoral neck and/or acetabulum has been confirmed via radiographic finding on MRI or x-ray.
  3. Subject provides voluntary signature on the IRB approved Informed Consent Form.
  4. Subject is at least 18 years of age.
  5. Subject must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol and complete outcome forms via email, telephone, in-person or by regular mail.

Exclusion Criteria:

• Candidates will be excluded if they meet ANY of the following:

  1. Subject has collapse of subchondral bone.
  2. Subject is pregnant at the time of surgery.
  3. Subject is incarcerated.
  4. Subject is involved in active litigation related to the condition being treated.
  5. Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Publications and helpful links

Helpful Links

• The Subchondroplasty® (SCP®) Procedure

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2018
• Primary Completion (Actual): October 23, 2023
• Study Completion (Actual): January 13, 2025

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Arthroscopy; Subchondroplasty; Bone Substitute Material; Subchondral Bone Defect; AccuFill; Bone Marrow Lesion
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries; Pathologic Processes; Neoplasms; Joint Diseases; Fractures, Bone; Cysts; Hip Injuries; Joint Dislocations; Pathological Conditions, Signs and Symptoms; Femoracetabular Impingement; Fractures, Stress; Hip Dislocation; Bone Cysts
• Other Study ID Numbers: CSU2017-03KC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No