Skip to main content
OpenTrials
Completed

NCT Number: NCT02256891

Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique

This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of patients treated with arthroscopic rotator cuff repair using one of two techniques. One technique used is the standard double row repairs utilizing medial and laterally based anchor fixation and the other technique is the standard double row repairs utilizing medial and laterally based anchor fixation with the use of plateley rich fibrin membrane (PRFM). It is hypothesized that patients undergoing the surgery with the PRFM will report a higher quality of life than the patients that do not receive this treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rotator Cuff Tear Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rotator Cuff Injuries Rupture Shoulder Injuries Shoulder Pain Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

TRIA Orthopaedic Center

Bloomington, Minnesota, 55431, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Evidence of a rotator cuff tear as determined by clinical examination and diagnostic imaging (MRI)
  • Patient undergoes arthroscopic rotator cuff repair
  • Age 18 or older

Exclusion criteria

Pre-operative exclusion criteria

  • Patient has had a previous arthroscopic rotator cut repair
  • A previous diagnosis of Rheumatoid Arthritis
  • Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder, or previous surgery of the affected shoulder,
  • Evidence of significant rotator cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations,
  • Medical device that would exclude the patient from having a MRI, including a pacemaker, cardiac defibrillator, aneurysm clips, carotid artery clamp, neurostimulator, insulin or infusion pump, implanted drug infusion device, bone growth/fusion stimulator, or ear implant.
  • Major medical illness (life expectancy less then 2 years or unacceptably high operative risk),
  • Inability to speak or read English
  • Psychiatric illness that precludes informed consent.
  • Pregnant patients.
  • Age 17 or younger
  • Unwillingness to be followed for 2 years.
  • Bilateral Rotator cuff tear confirmed by clinical exam and MRI
  • Patients enrolled in the study who demonstrate retear on clinical exam and MRI, then elect for a repeat surgery.

Intra-operative exclusion criteria (Note: This information will be collected during the chart audit and patients will be excluded from the study at that time.)

  • Irreparable cuff tears or tears extending into the subscapularis or teres minor
  • Isolated teres minor or subscapularis tears.
  • Inelastic and immobile tendon which cannot be advanced to articular margin

Treatment and study plan

PRFM

Device

Double row

Procedure

Primary outcomes

  1. Return to Function

    Time frame: Baseline

    The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.

  2. Return to Function

    Time frame: 6 months

    The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.

  3. Return to Function

    Time frame: 24 months

    Western Ontario Rotator Cuff Index

Other outcomes

  1. Spraspinatus Strength Measurements

    Time frame: Baseline

    Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.

  2. MRI

    Time frame: 6 months

    MRI was used to determine size of the defect in the proximal to distal, humeral to bursal, superior to inferior direction in all four tendons. All post operative rotator cuffs were described using the MRI rating system of Sugaya. This classification distinguishes 5 outcomes of rotator cuff repair based on integrity of the tendon determine by post operative MRI. Type I demonstrates the repaired rotator cuff has sufficient thickness and homogeneously low intensity on each image; Type II sufficient thickness with a partial high intensity area; Type III insufficient thickness without discontinuity, Type IV the presence of a minor discontinuity in more than one slice of each image suggestive of small tear; Type V the presence of a major discontinuity on each image suggestive of a large tear.

    Higher grades are worse radiographic outcomes.

  3. Supraspinatus Strength Measurements

    Time frame: 6 months

    Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.

  4. Supraspinatus Strength Measurements

    Time frame: 24 months

    Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.

  5. Infraspinatus Strength Measurements

    Time frame: Baseline

    Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.

  6. Infraspinatus Strength Measurements

    Time frame: 6 months

    Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.

  7. Infraspinatus Strength Measurements

    Time frame: 24 months

    Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Musculoskeletal Transplant Foundation

Registry information

Official study title

Arthroscopic Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique: A Randomized Blinded Outcomes Study

Acronym: RCRPRFM

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 6, 2014
Registry last updated
Aug 9, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.