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SCP Hip Outcomes Study

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ClinicalTrials.gov Identifier: NCT03494660
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment
Subchondral Cysts Subchondral Bone Edema Bone Marrow Edema Insufficiency Fractures Avascular Necrosis of Hip Femoroacetabular Impingement Dysplasia; Hip 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 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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Hip
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2025

Intervention Details:
  • Device: Subchondroplasty Procedure with AccuFill
    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 Outcome Measures :
  1. Change in Modified Harris Hip Score (mHHS) from baseline at 12 months [ Time Frame: 12 months ]
    Change in Modified Harris Hip Score using a 0-100 overall score, from baseline at 12 months. 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 Outcome Measures :
  1. Incidence and severity of device and/or procedure related adverse events and surgical conversions [ Time Frame: 5 years ]
    Summary and description of procedure and device related adverse events and surgical conversions and relatedness to the bone substitute material and procedure

  2. Change in numeric pain score from baseline at 12 months [ Time Frame: 12 months ]
    Change in numeric pain score using a 0-10 scale, from baseline at 12 months. Patient's current hip pain will be selected where 0 describes no pain and 10 describes worst possible pain on average over the past 24 hours.

  3. Change in Hip Outcome Score from baseline at 12 months [ Time Frame: 12 months ]

    Change in patient Activities of Daily Living and Sports, from baseline at 12 months.

    The Activities of Daily Living (ADL) and Sports subscales are scored separately. On the ADL subscale, the score on each of the items are added together to get the item score total. The total number of items with a response is multiplied by 4 to get the highest potential score. If the subject answers all 17 items, the highest potential score is 68. If one item is not answered the highest score is 64, if two are not answered the total highest score is 60, etc. The item score total is divided by the highest potential score. This value is then multiplied by 100 to get a percentage.

    The Sports subscale is scored in a similar manner with the highest potential score being 36. A higher score represents a higher level of physical function for both the ADL and Sports subscales.


  4. Change in EuroQol-5 Dimensions (EQ-5D) from baseline at 12 months [ Time Frame: 12 months ]
    Change in patient quality of life from baseline at 12 months. A scoring function is created using a population preference weighted health index.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 100 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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494660


Contacts
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Contact: Lynsey Boyle, BS 484-467-7047 lynsey.boyle@zimmerbiomet.com
Contact: Marianne Rahme, BA 484-873-3343 marianne.rahme@zimmerbiomet.com

Locations
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United States, California
Eisenhower Desert Orthopedic Center Recruiting
Rancho Mirage, California, United States, 92270
Contact: Charles Cyr       ccyr@desertortho.com   
Contact: Wendy Monaco       wmonaco@desertortho.com   
Principal Investigator: Matthew Diltz, MD         
United States, Illinois
NorthShoreUniversity HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Meryem Saracoglu       MSaracoglu@northshore.org   
Contact: Abigail Warren       AWarren@northshore.org   
Principal Investigator: Patrick Birmingham, MD         
OrthoIllinois Recruiting
Rockford, Illinois, United States, 61114
Contact: Lisa Foti, MS       lisa.foti@orthoillinois.com   
Contact: Sean Kampe, MS       sean.kampe@orthoillinois.com   
Principal Investigator: Geoffrey Van Thiel, MD         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43202
Contact: Angela Pedroza, MPH       Angela.Pedroza@osumc.edu   
Principal Investigator: William K Vasileff, MD         
Sub-Investigator: John Ryan, MD         
Sponsors and Collaborators
Zimmer Biomet

Additional Information:
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03494660     History of Changes
Other Study ID Numbers: CSU2017-03KC
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Zimmer Biomet:
Subchondroplasty
Bone Marrow Lesion
Arthroscopy
Bone Substitute Material
AccuFill
Subchondral Bone Defect

Additional relevant MeSH terms:
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Bone Cysts
Femoracetabular Impingement
Edema
Necrosis
Fractures, Stress
Signs and Symptoms
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Fractures, Bone
Wounds and Injuries
Cysts
Neoplasms
Bone Diseases