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OpenTrials
Completed

NCT Number: NCT03594071

S&P 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

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Key information

Conditions

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

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Orthopaedic Center- Center for Advanced Orthopaedics, Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Q-Fix™ All-Suture Anchor

Device

Observational, post-market, clinical follow-up study

Primary outcomes

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

    Time frame: 6 months

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

Secondary outcomes

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

    Time frame: 12 months

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

  2. Hip Visual Analog Scale (VAS) - Pain

    Time frame: Screening, 6 months, and 12 months

    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.

  3. Knee Visual Analog Scale (VAS) - Pain

    Time frame: Screening, 6 months, and 12 months

    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.

  4. Shoulder Visual Analog Scale (VAS) - Pain

    Time frame: Screening, 6 months, and 12 months

    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.

  5. Hip Range of Motion (ROM)

    Time frame: Screening, 6 months, and 12 months

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

  6. Knee Range of Motion (ROM)

    Time frame: Screening, 6 months, and 12 months

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

  7. Shoulder Range of Motion (ROM)

    Time frame: Screening, 6 months, and 12 months

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

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 20, 2018
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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