Instability, JointNCT03691298
Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair
An observational study of Instability, Joint, run by Smith & Nephew Orthopaedics AG at 9 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Instability, Joint
- What is being tested?
- SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor
- Type of treatment
- Medical device
- How many people
- 83 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 7 Nov 2018to 21 May 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject with hip or shoulder instability
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
United States2 sites
Orthotennessee
Knoxville, Tennessee, 37922
New York University Langone Orthopaedic Center
New York, New York, 10016
Spain2 sites
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Asepeyo Hospital Sant Cugat
Sant Cugat del Vallès, Barcelona, 08174
United Kingdom2 sites
Queen Alexandra Hospital
Cosham, PO6 3LY
Fortius Clinic
London, W1H 6EQ
About this study
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
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.
Read the 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.
- Conditions
- Instability, Joint
- Being tested
- SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor
- Keywords
- Suturefix, hip instability, shoulder instability
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture AnchorDevice
Fixation device intended to provide secure fixation of soft tissue to bone
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic hip and shoulder repair | Not described Receives: Device: SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success at 6 Months
Number of participants without signs of failure and/or re-intervention as assessed by the surgeon.
Measured: 6 month post-surgery
Secondary outcomes (12)
Clinical Success at 12 Months
Number of participants without signs of failure and/or re-intervention at 12 months, as assessed by the surgeon.
Measured: 12 months post-operative
Intra-operative Anchor Deployment Success
Number of suture anchors that were successfully deployed to bone, soft tissues, or both.
Measured: Intraoperatively
Intraoperative Suture Anchor Failure
Suture anchor failures categorized by number of participants with:
- Intra-operative failures (Yes/No)
- Anchors pulled out (Yes/No)
- Additional anchors used as a result of failure (Yes/No)
Measured: Intraoperatively
Device-related Re-Intervention
Number of participants with a device-related adverse event (AE) that required a re-intervention due to the device-related AE.
Measured: 12 months
Visual Analog Scale (VAS) Pain Score - All Participants
Assessed participant pain using Visual Analog Scale (VAS) assessments taken 6 and 12 months postoperative intervals. The VAS Pain Score was based on a scale of 0 to 10, with 0 representing no pain and 10 the worst possible pain.
Note: This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.
Measured: 6 and 12 months postoperative
Visual Analog Scale (VAS) Satisfaction Score - All Participants
Assessed participant satisfaction using a Visual Analog Scale (VAS) assessments taken at 6 and 12 month postoperative intervals. The VAS Subject Satisfaction Questionnaire was based on a scale of 0 to 10, with 0 representing very satisfied and 10 very unsatisfied.
This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.
Measured: 6 and 12 months postoperative
Analysis of EQ-5D-5L Index - All Participants
The EQ-5D-5L Index Score was based on a scale of 0 to 1, with higher index values indicating better health and lower index values indicating worse health.
This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.
Measured: 6 months and 12 months postoperative
Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants
The Hip Outcome Score Activities of Daily Living (HOOS-ADL) Score included 5 domains (Symptoms, Pain, Daily Living, Sport \& Recreation and Quality of Life) each assessed at 6 and 12 months postoperative. Each HOOS domain range was based on a scale of 0 to 100, where 0 represents extreme symptoms and 100 represents no symptoms.
Measured: 6 and 12 months postoperative
Modified Harris Hip Score (mHHS) - Hip Participants
The Modified Harris Hip Score (mHHS) is a measurement of dysfunction; the higher the score, the better the outcome. The mHHS score range was as follows:
- <70 (poor result)
- 70-79 (fair result)
- 80-89 (good result)
- >90 (excellent result)
This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.
Measured: Preoperative, 6 and 12 months Postoperative
Rowe Score - Shoulder Participants
The Rowe Scores address categories of shoulder stability, motion, and function. Scores range from 0 to 100 with a score of 90 to 100 points indicating an excellent evaluation, 75 to 89 points indicating a good evaluation, 51 to 74 points indicating a fair evaluation, and 0 to 50 points indicating a poor evaluation.
This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.
Measured: 6 and 12 months postoperative
American Shoulder and Elbow Surgeons Score - Shoulder Participants
The American Shoulder and Elbow Surgeons Score (ASES) was based on a scale of 0 to 100 points, where 0 indicated a worse shoulder condition and 100 indicated a better shoulder condition
Measured: 6 and 12 months postoperative
Constant-Murley Shoulder Scores (CMS) - Shoulder Participants
The Constant-Murley Shoulder Score (CMS) was based on a scale of 0 to 100 points divided into 4 subscales; pain (15 points), Activities of Daily Living (20 points), strength (25 points), and Range of Motion, including: forward elevation, external rotation, abduction, and internal rotation (40 points). The higher the score, the higher the quality of the function (less disability).
Measured: 6 months and 12 months Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start7 Nov 2018
- Primary completion21 May 2021
- Study completion21 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Instability, JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Everson, Study chair, Smith & Nephew Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691298
- Sponsor's protocol ID
- 17-5010-06
- Status last verified
- Jun 2022
- First submitted
- 28 Sep 2018
- Last updated
- 6 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03691298
- Acronym / sponsor ID
- 17-5010-06
- Conditions
- Instability, Joint
- Keywords
- Suturefix, hip instability, shoulder instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Posted 6 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic hip and shoulder repair | – | Device: SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject with hip or shoulder instability
Key inclusion criteria (7 listed)
- 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:
- Shoulder subjects only:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture AnchorFixation device intended to provide secure fixation of soft tissue to bone | Device | Arthroscopic hip and shoulder repair |
Primary outcome
Clinical Success at 6 Months
Time frame: 6 month post-surgery
Number of participants without signs of failure and/or re-intervention as assessed by the surgeon.
12 secondary outcomes
Clinical Success at 12 Months
Time frame: 12 months post-operative
Intra-operative Anchor Deployment Success
Time frame: Intraoperatively
Intraoperative Suture Anchor Failure
Time frame: Intraoperatively
Device-related Re-Intervention
Time frame: 12 months
Visual Analog Scale (VAS) Pain Score - All Participants
Time frame: 6 and 12 months postoperative
Visual Analog Scale (VAS) Satisfaction Score - All Participants
Time frame: 6 and 12 months postoperative
Analysis of EQ-5D-5L Index - All Participants
Time frame: 6 months and 12 months postoperative
Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants
Time frame: 6 and 12 months postoperative
Modified Harris Hip Score (mHHS) - Hip Participants
Time frame: Preoperative, 6 and 12 months Postoperative
Rowe Score - Shoulder Participants
Time frame: 6 and 12 months postoperative
American Shoulder and Elbow Surgeons Score - Shoulder Participants
Time frame: 6 and 12 months postoperative
Constant-Murley Shoulder Scores (CMS) - Shoulder Participants
Time frame: 6 months and 12 months Postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Everson study chair
Smith & Nephew Ltd
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Instability, Joint, run by Smith & Nephew Orthopaedics AG at 9 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Spain, United Kingdom, Denmark, Finland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success at 6 Months (time frame: 6 month post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.