Clinical trial NCT03691298: Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair
Official title: Prospective, Multicenter, Post-Market 1 Year Clinical Follow-up Study to Evaluate Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Instability, Joint
Keywords: Suturefix
hip instability
shoulder instability
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-01
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject with hip or shoulder instability

Brief summary: The scientific justification is to fulfill post-market clinical requirements in order to support re-certification of the CE-Mark for this marketed product and to look into safety and efficacy.

Detailed description: Shoulder: The superior labrum (fibrous cartilage) and biceps anchor improve joint stability by acting like a secondary stabilizer to the shoulder. Labral injuries are usually associated with anterior shoulder dislocation. When conservative treatment fails, such as physical therapy, strengthening programs, anti-inflammatories and activity modification to improve symptoms, surgical intervention may be required. Surgical treatments can include simple debridement, stabilization of the biceps-labrum complex through repair, or biceps tenodesis where the end of a tendon is joined surgically to the bone. Outcomes of SLAP (superior labral tear from anterior to posterior) repairs have been reported good throughout the literature, with reported success rates ranging from 71-97%.

Hip: The labrum of the hip is a fibrocartilaginous tissue that connects to the bone edge of the acetabulum (the socket of the hip bone), and deepens the acetabular socket while extending coverage of the femoral head; it also aids in hip stabilization. The goal of surgical intervention is to restore normal hip mechanics and treat existing damage.

Eligibility criteria: Inclusion Criteria:

* Subject has consented to participate in the study by signing the EC-approved informed consent form
* Subject condition meets proposed indication to SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchor
* Subject requiring shoulder or hip arthroscopic labral repair surgery from physical findings, subject symptoms and radiographic finding
* Hip subjects only:

  * FAI (Femoroacetabular Impingement)
* Shoulder subjects only:

  * Subject with a history of recurrent dislocation/subluxation of the shoulder

Exclusion Criteria:

* Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1 (pre-operative)
* Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures
* Contraindications or hypersensitivity to the use of the SUTUREFIX ULTRA and/or SUTUREFIX CURVED Suture Anchor, or their components (e.g. silicone, polyester). Where material sensitivity is suspected, appropriate tests should be performed 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
* Hip subjects only:

  * Dysplasia latera/central less than 20°
* Shoulder subjects only:

  * Glenoid and/or humeral bone loss considered excessive by the treating orthopaedic surgeon

Primary outcomes:
measure: Clinical Success at 6 Months
timeFrame: 6 month post-surgery
Secondary outcomes:
measure: Clinical Success at 12 Months
timeFrame: 12 months post-operative
measure: Intra-operative Anchor Deployment Success
timeFrame: Intraoperatively
measure: Intraoperative Suture Anchor Failure
timeFrame: Intraoperatively
measure: Device-related Re-Intervention
timeFrame: 12 months
measure: Visual Analog Scale (VAS) Pain Score - All Participants
timeFrame: 6 and 12 months postoperative
measure: Visual Analog Scale (VAS) Satisfaction Score - All Participants
timeFrame: 6 and 12 months postoperative
measure: Analysis of EQ-5D-5L Index - All Participants
timeFrame: 6 months and 12 months postoperative
measure: Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants
timeFrame: 6 and 12 months postoperative
measure: Modified Harris Hip Score (mHHS) - Hip Participants
timeFrame: Preoperative, 6 and 12 months Postoperative
measure: Rowe Score - Shoulder Participants
timeFrame: 6 and 12 months postoperative
measure: American Shoulder and Elbow Surgeons Score - Shoulder Participants
timeFrame: 6 and 12 months postoperative
measure: Constant-Murley Shoulder Scores (CMS) - Shoulder Participants
timeFrame: 6 months and 12 months Postoperative
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Orthopaedic Center
state: New York
city: Knoxville
country: United States
facility: Orthotennessee
state: Tennessee
city: Farum
country: Denmark
facility: CPH Privathospital
city: Turku
country: Finland
facility: Pihlajalinna Turku Hospital
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Sant Cugat del Vallès
country: Spain
facility: Asepeyo Hospital Sant Cugat
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Cosham
country: United Kingdom
facility: Queen Alexandra Hospital
city: London
country: United Kingdom
facility: Fortius Clinic
Study officials:
affiliation: Smith & Nephew Ltd
name: Laura Everson
role: STUDY_CHAIR
References: