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

Safety and Performance of Q-Fix™ All-Suture Anchor System

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

Study Overview

• Status: Completed
• Conditions: 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
• Intervention / Treatment: Device: The Q-Fix™ All-Suture Anchor

• Study Type: Observational
• Enrollment (Actual): 294

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

US sites

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months
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.	Screening, 6 months, and 12 months
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.	Screening, 6 months, and 12 months
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.	Screening, 6 months, and 12 months
Hip Range of Motion (ROM)	Full Range of Motion (ROM) defined as full functional arc in hip by the physician.	Screening, 6 months, and 12 months
Knee Range of Motion (ROM)	Full Range of Motion (ROM) defined as full functional arc in knee by the physician	Screening, 6 months, and 12 months
Shoulder Range of Motion (ROM)	Full Range of Motion (ROM) defined as full functional arc in shoulder by the physician.	Screening, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Chair: Lisa Langone, GBR - T. J. Smith and Nephew Limited

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2018
• Primary Completion (Actual): December 11, 2019
• Study Completion (Actual): December 11, 2019

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Shoulder Injuries; Tendon Injuries; Shoulder Fractures; Tendinopathy; Bankart Lesions
• Other Study ID Numbers: 17-5010-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes