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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky Research Foundation
Lexington, Kentucky 40506
Contact:
Emily Hunt, MS ATC
Emily.hunt@uky.edu

More Details

NCT ID
NCT03494660
Status
Recruiting
Sponsor
Zimmer Biomet

Study Contact

Lynsey Boyle, BS
484-467-7047
lynsey.boyle@zimmerbiomet.com

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 100 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. A member of the study staff will contact subjects post-operatively at 3 years, 4 years and 5 years by telephone to verify completion of the Numeric Pain Scale and a Subject Global Satisfaction Survey. Screening for adverse events and conversion will occur throughout the study.

Subjects will complete the study at 5 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.