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CompletedNCT03594071Updated Feb 9, 2021Results posted

S&P of Q-Fix™ All-Suture Anchor System

An observational study in Bankart Lesion, Acetabular Labrum Tear and SLAP Lesion, sponsored by Smith & Nephew, Inc.. Completed at 5 sites in United States. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-09.

Sponsored by Smith & Nephew, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
294
Ages
13 Years and older
Sex
All
01

Study summary

Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements

02

Conditions studied

  • Bankart Lesion
  • Acetabular Labrum Tear
  • SLAP Lesion
  • Acromioclavicular Sprain
  • Capsular Shift/Capsulolabral Reconstruction
  • Deltoid Repair
  • Rotator Cuff Repair
  • Bicep Tendinitis
  • Extra-capsular Repair
  • Medial Collateral Ligament
  • Lateal Collateral Ligament
  • Posterior Oblique Ligament
  • IBT
  • Vastus Medialis
  • Obliquus Advancement
  • Joint Capsule Closure

Browse trials for

03

In context

Tendinopathy

413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.

This study's enrollment of 294 is above the median of 67 across 52 observational studies indexed under Tendinopathy.

Browse Tendinopathy studies →

Lead sponsor

Smith & Nephew, Inc. is the lead sponsor of 132 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

US sites

Inclusion criteria

  • Subject has undergone arthroscopic or open soft tissue repair with Q-Fix™ All-Suture Anchor System
  • Subject was ≥ 13 of age at time of surgery

Exclusion criteria

Exclusion Criteria:

  • Subject is ≤ 6 months post-operative
  • Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
294 participants (actual)
Patient registry
No

Interventions

  • DeviceThe Q-Fix™ All-Suture Anchor

    Observational, post-market, clinical follow-up study

06

What researchers measure

Primary outcomes

  1. Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon

    All individuals for whom the outcome of re-intervention is known at 6 months

    Time frame: 6 months

Secondary outcomes

  1. Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon

    All individuals for whom the outcome of re-intervention is known at 12 months

    Time frame: 12 months

  2. Hip Visual Analog Scale (VAS) - Pain

    VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain.

    Time frame: Screening, 6 months, and 12 months

  3. Knee Visual Analog Scale (VAS) - Pain

    VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain.

    Time frame: Screening, 6 months, and 12 months

  4. Shoulder Visual Analog Scale (VAS) - Pain

    VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain.

    Time frame: Screening, 6 months, and 12 months

  5. Hip Range of Motion (ROM)

    Full Range of Motion (ROM) defined as full functional arc in hip by the physician.

    Time frame: Screening, 6 months, and 12 months

  6. Knee Range of Motion (ROM)

    Full Range of Motion (ROM) defined as full functional arc in knee by the physician

    Time frame: Screening, 6 months, and 12 months

  7. Shoulder Range of Motion (ROM)

    Full Range of Motion (ROM) defined as full functional arc in shoulder by the physician.

    Time frame: Screening, 6 months, and 12 months

07

Results

Posted Feb 9, 2021

Participant flow

The study enrolled 294 subjects at 5 investigational sites in the United States. This included a total of 309 joints: 134 hips, 118 shoulders, and 57 knees.

Participant flow — Overall Study
MilestoneSafety Population
Started294
Completed289
Not completed5
Withdrew: Re-operation3
Withdrew: Missed visit2

Outcome measures

PrimaryClinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon

All individuals for whom the outcome of re-intervention is known at 6 months

Time frame:
6 months
Reported as:
Count of units · joints
Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon
jointsSafety Population
Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon306
SecondaryClinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon

All individuals for whom the outcome of re-intervention is known at 12 months

Time frame:
12 months
Reported as:
Count of units · joints
Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon
jointsSafety Population
Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon118
SecondaryHip Visual Analog Scale (VAS) - Pain

VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain.

Time frame:
Screening, 6 months, and 12 months
Reported as:
Mean · score on a scale
Hip Visual Analog Scale (VAS) - Pain
score on a scaleSafety Population
Hip: Screening51.0 ± 21.7
Hip: 6 months24.4 ± 20.7
Hip: 12 months16.3 ± 18.3
SecondaryKnee Visual Analog Scale (VAS) - Pain

VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain.

Time frame:
Screening, 6 months, and 12 months
Reported as:
Mean · score on a scale
Knee Visual Analog Scale (VAS) - Pain
score on a scaleSafety Population
Knee: Screening51.3 ± 25.3
Knee: 6 months10.0 ± 17.3
Knee: 12 months23.3 ± 40.4
SecondaryShoulder Visual Analog Scale (VAS) - Pain

VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain.

Time frame:
Screening, 6 months, and 12 months
Reported as:
Mean · score on a scale
Shoulder Visual Analog Scale (VAS) - Pain
score on a scaleSafety Population
Shoulder: Screening53.3 ± 26.4
Shoulder: 6 months28.8 ± 25.4
Shoulder: 12 months35.6 ± 27.4
SecondaryHip Range of Motion (ROM)

Full Range of Motion (ROM) defined as full functional arc in hip by the physician.

Time frame:
Screening, 6 months, and 12 months
Reported as:
Count of units · joints
Hip Range of Motion (ROM)
jointsSafety Population
Hip: Screening - has full functional arc — Yes37
Hip: Screening - has full functional arc — No90
Hip: Screening - has full functional arc — Missing7
Hip: 6 months- has full functional arc — Yes45
Hip: 6 months- has full functional arc — No81
Hip: 6 months- has full functional arc — Missing7
Hip: 12 months- has full functional arc — Yes32
Hip: 12 months- has full functional arc — No42
Hip: 12 months- has full functional arc — Missing4
SecondaryKnee Range of Motion (ROM)

Full Range of Motion (ROM) defined as full functional arc in knee by the physician

Time frame:
Screening, 6 months, and 12 months
Reported as:
Count of units · joints
Knee Range of Motion (ROM)
jointsSafety Population
Knee: Screening - has full functional arc — Yes28
Knee: Screening - has full functional arc — No14
Knee: Screening - has full functional arc — Missing15
Knee: 6 months- has full functional arc — Yes24
Knee: 6 months- has full functional arc — No25
Knee: 6 months- has full functional arc — Missing7
Knee: 12 months- has full functional arc — Yes7
Knee: 12 months- has full functional arc — No6
Knee: 12 months- has full functional arc — Missing1
SecondaryShoulder Range of Motion (ROM)

Full Range of Motion (ROM) defined as full functional arc in shoulder by the physician.

Time frame:
Screening, 6 months, and 12 months
Reported as:
Count of units · joints
Shoulder Range of Motion (ROM)
jointsSafety Population
Shoulder: Screening - has full functional arc — Yes14
Shoulder: Screening - has full functional arc — No100
Shoulder: Screening - has full functional arc — Missing4
Shoulder: 6 months- has full functional arc — Yes24
Shoulder: 6 months- has full functional arc — No90
Shoulder: 6 months- has full functional arc — Missing1
Shoulder: 12 months- has full functional arc — Yes8
Shoulder: 12 months- has full functional arc — No16
Shoulder: 12 months- has full functional arc — Missing3

Adverse events

Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Safety Population0/294 (0%)22/294 (7.5%)81/294 (27.6%)
Most frequent serious events
Showing 10 of 18
Most frequent serious events
EventSafety Population
Biceps tear/tendon ruptureInjury, poisoning and procedural complications2/294
Biceps tear/tendon ruptureInjury, poisoning and procedural complications2/294
Bone fractureInjury, poisoning and procedural complications2/294
Knee ArthrofibrosisMusculoskeletal and connective tissue disorders2/294
Recurrent rotator cuff tearRespiratory, thoracic and mediastinal disorders2/294
Abcess of shoulderInfections and infestations1/294
Adhesive capsulitisMusculoskeletal and connective tissue disorders1/294
Biceps tear/tendon ruptureInjury, poisoning and procedural complications1/294
Graves diseaseGeneral disorders1/294
Hip painGeneral disorders1/294
Most frequent other events
Showing 10 of 41
Most frequent other events
EventSafety Population
Hip painGeneral disorders19/294
InjuryInjury, poisoning and procedural complications8/294
Numbness/weaknessGeneral disorders8/294
Clicking/popping sensationMusculoskeletal and connective tissue disorders7/294
Leg painGeneral disorders6/294
Shoulder painGeneral disorders5/294
Clicking/popping sensationMusculoskeletal and connective tissue disorders4/294
PainGeneral disorders4/294
Groin painGeneral disorders3/294
Adhesive capsulitisMusculoskeletal and connective tissue disorders2/294

Baseline characteristics

Age, Continuous
Age, Continuous(years)Safety Population
Mean37.10 ± 16.60
Sex: Female, Male
Sex: Female, Male(Participants)Safety Population
Female147
Male147
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Safety Population
White228
Asian4
Black or African American29
American Indian or Alaska Native4
Other7
Unknown22
Region of Enrollment
Region of Enrollment(participants)Safety Population
United States294
Height
Height(cm)Safety Population
Mean171.19 ± 11.449
Weight
Weight(pounds (lb))Safety Population
Mean177.33 ± 46.045
Body Mass Index
Body Mass Index(kg/m^2)Safety Population
Mean27.39 ± 7.060
Ethnicity
Ethnicity(Participants)Safety Population
Hispanic/Latino15
Not Hispanic/Latino242
08

Study locations

5 sites
  • The Orthopaedic Center- Center for Advanced Orthopaedics
    Washington, District of Columbia 20037, United States
  • Northshore University Health System
    Chicago, Illinois 60201, United States
  • Tulane University Medical Center /Tulane Institute of Sport Medicine
    New Orleans, Louisiana 70112, United States
  • Oklahoma Sports and Orthopedics Institute
    Oklahoma City, Oklahoma 73072, United States
  • Palmetto Health USC Orthopedic Center
    Columbia, South Carolina 29203, United States
09

References and documents

Study documents

  • Study protocol · Sep 9, 2019
  • Statistical analysis plan · Oct 28, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — * Study Protocol * Clinical Study Report (CSR)

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03594071
Lead sponsor
Smith & Nephew, Inc.
Responsible party
Sponsor
First posted
Jul 20, 2018
Start date
Aug 31, 2018
Primary completion
Dec 11, 2019
Completion
Dec 11, 2019
Results posted
Feb 9, 2021
Last update
Feb 9, 2021

Study contacts

Lisa Langone
study chair · GBR - T. J. Smith and Nephew Limited

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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