SCP Hip Outcomes Study

NCT03494660 | Completed Results FDA Device

• 1 other identifier: CSU2017-03KC
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Subchondral Cysts; Subchondral Bone Edema; Bone Marrow Edema; Insufficiency Fractures; Avascular Necrosis of Hip; Femoroacetabular Impingement; Dysplasia; Hip

Keywords

Subchondroplasty; Bone Marrow Lesion; Arthroscopy; Bone Substitute Material; AccuFill; Subchondral Bone Defect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Pain and Functional Performance by Numeric Pain Scale (NPS)

  2 weeks postoperative

• Pain and Functional Performance by Numeric Pain Scale (NPS)

  6 weeks postoperative

• Pain and Functional Performance by Numeric Pain Scale (NPS)

  12 weeks postoperative

• Pain and Functional Performance by Numeric Pain Scale (NPS)

  6 months postoperative

• Pain and Functional Performance by Numeric Pain Scale (NPS)

  1 year postoperative

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (6)

Eisenhower Desert Orthopedic Center

Rancho Mirage, California, 92270, United States

Location

Andrews Research & Education Foundation

Gulf Breeze, Florida, 32561, United States

Location

OrthoIllinois

Rockford, Illinois, 61114, United States

Location

University of Kentucky Research Foundation

Lexington, Kentucky, 40506, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43202, United States

Location

Related Links

• The Subchondroplasty® (SCP®) Procedure

MeSH Terms

Conditions

Bone Cysts; Fractures, Stress; Femoracetabular Impingement; Hip Dislocation

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Fractures, Bone; Wounds and Injuries; Joint Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Dislocations; Hip Injuries

Results Point of Contact

• Title: Annette Tieu
• Organization: Zimmer Biomet

annette.tieu@zimmerbiomet.com

971-482-9622

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 11, 2018
• Study Start: March 27, 2018
• Primary Completion: October 23, 2023
• Study Completion: January 13, 2025
• Last Updated: April 21, 2026
• Results First Posted: April 21, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)