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

Primary Purpose

Rotator Cuff Tear

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
PRFM
Double Row
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Rotator cuff tear, Rotator cuff injury, Shoulder pain, Shoulder injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • TRIA Orthopaedic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Double Row

Double Row with PRFM

Arm Description

Double Row

Double Row with PRFM

Outcomes

Primary Outcome Measures

Return to Function
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.
Return to Function
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.
Return to Function
Western Ontario Rotator Cuff Index

Secondary Outcome Measures

Full Information

First Posted
August 4, 2014
Last Updated
July 11, 2017
Sponsor
HealthPartners Institute
Collaborators
Musculoskeletal Transplant Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02256891
Brief Title
Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique
Acronym
RCRPRFM
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
Musculoskeletal Transplant Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
Rotator cuff tear, Rotator cuff injury, Shoulder pain, Shoulder injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Double Row
Arm Type
Experimental
Arm Description
Double Row
Arm Title
Double Row with PRFM
Arm Type
Experimental
Arm Description
Double Row with PRFM
Intervention Type
Device
Intervention Name(s)
PRFM
Intervention Type
Procedure
Intervention Name(s)
Double Row
Primary Outcome Measure Information:
Title
Return to Function
Description
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.
Time Frame
Baseline
Title
Return to Function
Description
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.
Time Frame
6 months
Title
Return to Function
Description
Western Ontario Rotator Cuff Index
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Spraspinatus Strength Measurements
Description
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.
Time Frame
Baseline
Title
MRI
Description
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.
Time Frame
6 months
Title
Supraspinatus Strength Measurements
Description
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.
Time Frame
6 months
Title
Supraspinatus Strength Measurements
Description
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.
Time Frame
24 months
Title
Infraspinatus Strength Measurements
Description
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.
Time Frame
Baseline
Title
Infraspinatus Strength Measurements
Description
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.
Time Frame
6 months
Title
Infraspinatus Strength Measurements
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
TRIA Orthopaedic Center
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States

12. IPD Sharing Statement

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

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