Clinical trial NCT03985839: Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip
Official title: Prospective Multi-Center Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the MICRORAPTOR REGENESORB, Knotless REGENESORB and Knotless PEEK Suture Anchors (and MINITAPE Sutures) in Shoulder and Hip Arthroscopic Instability Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labral Tear, Glenoid
Acetabular Labrum Tear
Bankart Lesions
Anterior Shoulder Instability
SLAP Lesion
Rotator Cuff Tears
Keywords: Microraptor, suture anchor, knotless, Smith and Nephew
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-14
Enrollment: 299
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject requires reattachment of soft tissue to bone for the following indications:

* Shoulder - Capsular stabilization for Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Rotator Cuff Repairs (knotless anchors only)
* Hip - Acetabular labrum repair/reconstruction

Brief summary: This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors implanted in 300 subjects needing reattachment of soft tissue to bone.

Detailed description: The purpose of this trial is to assess, by product, safety and performance post-market of the Microraptor Regenesorb, Microraptor Knotless Regenesorb, and Microraptor Knotless PEEK Suture Anchors. Approximately 18 sites (approximately 3 sites for study shoulder group and 3 sites for study hip group, per product) in the United States will participate in the study. This is an open-label study with consecutive enrollment. The study will continue for 24 months from the date that the last subject received the study treatment to the date that the last subject completes the study as planned. The study duration is planned for 36 months.

Eligibility criteria: Inclusion Criteria:

* Subject requires reattachment of soft tissue to bone for the following indications:

  * Shoulder - Capsular stabilization for Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Rotator Cuff Repairs (knotless anchors only)
  * Hip - Acetabular labrum repair/reconstruction
* Subject has consented to participate in the study by signing the EC-approved informed consent form.
* Subject is ≥18 years of age at time of surgery.
* Willing and able to make all required study visits.
* Able to follow instructions.

Exclusion Criteria:

* Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
* Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation.
* Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture.
* Comminuted bone surface, which would compromise secure anchor fixation.
* Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing.
* The presence of infection.
* Conditions which would limit the subject's ability or willingness to restrict activities or follow directions during the healing period.
* Currently using tobacco products (cigarette, smokeless tobacco, ecigarettes, vaping etc.).
* Concurrent bilateral surgery.
* Prior MICRORAPTOR REGENESORB, MICRORAPTOR Knotless REGENESORB, or MICRORAPTOR Knotless PEEK implantation.
* Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.
* Women who are pregnant or nursing.
* History of poor compliance with medical treatment.
* Prior ipsilateral surgeries performed on the joint space.
* Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Primary outcomes:
measure: Repair failure rate
timeFrame: 6 months
Secondary outcomes:
measure: Repair failure rate
timeFrame: 12 months
measure: ROWE shoulder score
timeFrame: 6 and 12 months
measure: WOSI shoulder score
timeFrame: 6 and 12 months
measure: Constant-Murley Shoulder Scale
timeFrame: 6 and 12 months
measure: HOS-ADL Score
timeFrame: 6 and 12 months
measure: Modified Harris Hip Score
timeFrame: 6 and 12 months
measure: Adverse Events (AEs)
timeFrame: 12 months
measure: Anchor absorption/replacement by bone (Knotless Regenesorb only)
timeFrame: 6 and 24 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Orthopaedic Group
state: Colorado
city: Oakland Park
country: United States
facility: Holy Cross Orthopedic Institute
state: Florida
city: Brookhaven
country: United States
facility: Emory University - Brookhaven
state: Georgia
city: Annapolis
country: United States
facility: Luminis Health Research Institute
state: Maryland
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Sports and Science Orthopedics / The Physician's Group
state: Oklahoma
city: Columbia
country: United States
facility: Palmetto/Prisma Health - University of South Carolina Orthopaedics
state: South Carolina
city: Greenville
country: United States
facility: Steadman Hawkins Clinic of the Carolinas
state: South Carolina
city: Virginia Beach
country: United States
facility: Atlantic Orthopaedic Specialists
state: Virginia
city: Woodbridge
country: United States
facility: Center for Advanced Orthopaedics / Nova Orthopedic & Spine Care
state: Virginia
city: Ashland
country: United States
facility: Memorial Medical Center
state: Wisconsin
Study officials:
affiliation: Smith & Nephew, Inc.
name: Mary Ozokwere
role: STUDY_CHAIR
References: