Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair

Instability, Joint Clinical Trial

— SuturefixUltra  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03691298
• Other study ID #: 17-5010-06
• Status: Completed
• Start date: October 17, 2018
• Est. completion date: May 21, 2021

Study information

• Verified date: June 2022
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 (the medical removal of dead damaged or infected tissue), 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. In an epidemiology study published in 2017, labral pathology was the most common diagnosis at 82% of the population. Of the 1,124 tears reported, 75.3% were repaired, 13.7% were reconstructed and 7.2% were debrided.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: May 21, 2021
• Est. primary completion date: May 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• FAI (Femoroacetabular Impingement) Shoulder subjects

• 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 Dysplasia latera/central less than 20° Shoulder subjects

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

Related Conditions & MeSH terms

• Instability, Joint
• Joint Instability

Intervention

Device:
• Suturefix Ultra and Suturefix Curved Suture Anchor
Fixation device intended to provide secure fixation of soft tissue to bone to stabilize hip

Locations

Country	Name	City	State
Denmark	CPH Privathospital	Farum
Finland	Pihlajalinna Turku Hospital	Turku
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Asepeyo Hospital Sant Cugat	Sant Cugat del Vallès	Barcelona
United Kingdom	Queen Alexandra Hospital	Cosham
United Kingdom	Fortius Clinic	London
United States	Orthotennessee	Knoxville	Tennessee
United States	New York University Langone Orthopaedic Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Countries where clinical trial is conducted

United States,  Denmark,  Finland,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success rate	Subjects without signs of failure and/or re-intervention	6 month post-surgery
Secondary	Clinical success rate	Subjects without signs of failure and/or re-intervention	12 months post-operative