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Completed

NCT Number: NCT03494660

SCP Hip Outcomes Study

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.

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Key information

Conditions

Subchondral Cysts Avascular Necrosis of Hip Bone Cysts Bone Diseases Bone Marrow Edema Cysts Dysplasia; Hip Femoracetabular Impingement Femoroacetabular Impingement Fractures, Bone Fractures, Stress Hip Dislocation Hip Injuries Insufficiency Fractures Joint Diseases Joint Dislocations Musculoskeletal Diseases Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Subchondral Bone Edema Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eisenhower Desert Orthopedic Center, Rancho Mirage, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Candidates must meet ALL of the following:
  • Surgeon considers the patient appropriate for the SCP Procedure of the hip.
  • Subchondral bone defect(s) in the femoral head, femoral neck and/or acetabulum has been confirmed via radiographic finding on MRI or x-ray.
  • Subject provides voluntary signature on the IRB approved Informed Consent Form.
  • Subject is at least 18 years of age.
  • 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:
  • Subject has collapse of subchondral bone.
  • Subject is pregnant at the time of surgery.
  • Subject is incarcerated.
  • Subject is involved in active litigation related to the condition being treated.
  • Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol.

Treatment and study plan

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).

Primary outcomes

  1. Overall Group Mean Improvement From Baseline of the Modified Harris Hip Score (mHHS) at 2 Years

    Time frame: 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.

Secondary outcomes

  1. Pain and Functional Performance by Numeric Pain Scale (NPS)

    Time frame: 2 weeks postoperative

    Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.

  2. Pain and Functional Performance by Numeric Pain Scale (NPS)

    Time frame: 6 weeks postoperative

    Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.

  3. Pain and Functional Performance by Numeric Pain Scale (NPS)

    Time frame: 12 weeks postoperative

    Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.

  4. Pain and Functional Performance by Numeric Pain Scale (NPS)

    Time frame: 6 months postoperative

    Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.

  5. Pain and Functional Performance by Numeric Pain Scale (NPS)

    Time frame: 1 year postoperative

    Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.

  6. Pain and Functional Performance by Numeric Pain Scale (NPS)

    Time frame: 2 years postoperative

    Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.

  7. Modified Harris Hip Score (mHHS)

    Time frame: 6 weeks postoperative

    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.

  8. Modified Harris Hip Score (mHHS)

    Time frame: 12 weeks postoperative

    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.

  9. Modified Harris Hip Score (mHHS)

    Time frame: 6 months postoperative

    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.

  10. Modified Harris Hip Score (mHHS)

    Time frame: 1 year postoperative

    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.

  11. Modified Harris Hip Score (mHHS)

    Time frame: 2 years postoperative

    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. Subject Quality-of-life Measured by the EQ-5D-5L Score

    Time frame: 6 weeks

    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.

  13. Subject Quality-of-life Measured by the EQ-5D-5L Score

    Time frame: 12 weeks

    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.

  14. Subject Quality-of-life Measured by the EQ-5D-5L Score

    Time frame: 6 months

    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.

  15. Subject Quality-of-life Measured by the EQ-5D-5L Score

    Time frame: 1 Year

    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.

  16. Subject Quality-of-life Measured by the EQ-5D-5L Score

    Time frame: 2 Years

    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.

  17. Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)

    Time frame: 6 Weeks

    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).

  18. Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)

    Time frame: 12 Weeks

    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).

  19. Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)

    Time frame: 6 Months

    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).

  20. Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)

    Time frame: 1 Year

    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).

  21. Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)

    Time frame: 2 Years

    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).

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2025
First posted
Apr 11, 2018
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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