N/A
N=83
Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair
Instability, Joint
Bottom Line
View on ClinicalTrials.gov: NCT03691298 ↗Enrolled (actual)
83
Serious AEs
4.8%
Results posted
Jan 2025
Primary outcome: Primary: Clinical Success at 6 Months — 56 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Smith & Nephew Orthopaedics AG
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Success at 6 Months |
56 | — |
| SECONDARY Clinical Success at 12 Months |
64 | — |
| SECONDARY Intra-operative Anchor Deployment Success |
73 | — |
| SECONDARY Intraoperative Suture Anchor Failure |
6; 67; 4; 25; 5; 23 | — |
| SECONDARY Device-related Re-Intervention |
1 | — |
| SECONDARY Visual Analog Scale (VAS) Pain Score - All Participants |
2.0; 1.0 | — |
| SECONDARY Visual Analog Scale (VAS) Satisfaction Score - All Participants |
2.30; 1.0 | — |
| SECONDARY Analysis of EQ-5D-5L Index - All Participants |
0.8; 0.9 | — |
| SECONDARY Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants |
74.5; 77.8; 85.1; 71.3; 64.2; 75.7 | — |
| SECONDARY Modified Harris Hip Score (mHHS) - Hip Participants |
51.3; 71.2; 71.9 | — |
| SECONDARY Rowe Score - Shoulder Participants |
93.3; 97.9 | — |
| SECONDARY American Shoulder and Elbow Surgeons Score - Shoulder Participants |
91.0; 95.7 | — |
| SECONDARY Constant-Murley Shoulder Scores (CMS) - Shoulder Participants |
77.9; 79.8 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03691298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.