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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03691298
Recruitment Status : Completed
First Posted : October 1, 2018
Last Update Posted : June 15, 2022
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc. ( Smith & Nephew Orthopaedics AG )

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.

Condition or disease Intervention/treatment
Instability, Joint Device: Suturefix Ultra and Suturefix Curved Suture Anchor

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 (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.

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Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : October 17, 2018
Actual Primary Completion Date : May 21, 2021
Actual Study Completion Date : May 21, 2021

Group/Cohort Intervention/treatment
Arthroscopic hip repair Device: Suturefix Ultra and Suturefix Curved Suture Anchor
Fixation device intended to provide secure fixation of soft tissue to bone to stabilize hip




Primary Outcome Measures :
  1. Clinical success rate [ Time Frame: 6 month post-surgery ]
    Subjects without signs of failure and/or re-intervention


Secondary Outcome Measures :
  1. Clinical success rate [ Time Frame: 12 months post-operative ]
    Subjects without signs of failure and/or re-intervention



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
Subject with hip or shoulder instability
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
  • 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

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): NCT03691298


Locations
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United States, New York
New York University Langone Orthopaedic Center
New York, New York, United States, 10016
United States, Tennessee
Orthotennessee
Knoxville, Tennessee, United States, 37922
Denmark
CPH Privathospital
Farum, Denmark, 3520
Finland
Pihlajalinna Turku Hospital
Turku, Finland, 20100
Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy, 00152
Spain
Asepeyo Hospital Sant Cugat
Sant Cugat del Vallès, Barcelona, Spain, 08174
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
United Kingdom
Queen Alexandra Hospital
Cosham, United Kingdom, PO6 3LY
Fortius Clinic
London, United Kingdom, W1H 6EQ
Sponsors and Collaborators
Smith & Nephew Orthopaedics AG
Investigators
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Study Chair: Emma Whatley, PhD Smith & Nephew Ltd
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Responsible Party: Smith & Nephew Orthopaedics AG
ClinicalTrials.gov Identifier: NCT03691298    
Other Study ID Numbers: 17-5010-06
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022
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: No
Keywords provided by Smith & Nephew, Inc. ( Smith & Nephew Orthopaedics AG ):
Suturefix
hip instability
shoulder instability
Additional relevant MeSH terms:
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Joint Instability
Joint Diseases
Musculoskeletal Diseases