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

Acetabular Labrum Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03594071
• Other study ID #: 17-5010-11
• Status: Completed
• Start date: August 31, 2018
• Est. completion date: December 11, 2019

Study information

• Verified date: January 2021
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: December 11, 2019
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• The Q-Fix™ All-Suture Anchor
Observational, post-market, clinical follow-up study

Locations

Country	Name	City	State
United States	Northshore University Health System	Chicago	Illinois
United States	Palmetto Health USC Orthopedic Center	Columbia	South Carolina
United States	Tulane University Medical Center /Tulane Institute of Sport Medicine	New Orleans	Louisiana
United States	Oklahoma Sports and Orthopedics Institute	Oklahoma City	Oklahoma
United States	The Orthopaedic Center- Center for Advanced Orthopaedics	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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