Clinical trial NCT03494660: SCP Hip Outcomes Study
Official title: A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Hip
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-04-11
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Modified Harris Hip Score (mHHS) from baseline at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Incidence and severity of device and/or procedure related adverse events and surgical conversions
timeFrame: 2 years
measure: Change in numeric pain score from baseline at 12 months
timeFrame: 12 months
measure: Change in Hip Outcome Score from baseline at 12 months
timeFrame: 12 months
measure: Change in EuroQol-5 Dimensions (EQ-5D) from baseline at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Eisenhower Desert Orthopedic Center
state: California
city: Gulf Breeze
country: United States
facility: Andrews Research & Education Foundation
state: Florida
city: Rockford
country: United States
facility: OrthoIllinois
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Research Foundation
state: Kentucky
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References: