Rotator Cuff TearPhase 4RCRPRFMNCT02256891

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

A Phase 4 study testing PRFM and Double Row in people with Rotator Cuff Tear, run by HealthPartners Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Rotator Cuff Tear
What is being tested?: PRFM and Double Row
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 97 participants
Where: 1 siteUnited States
Study dates: Jul 2011to Dec 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 18Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

TRIA Orthopaedic Center
Bloomington, Minnesota, 55431

Other trials in United States

About this study

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

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.

Conditions: Rotator Cuff Tear
Being tested: PRFM, Double Row
Keywords: Rotator cuff tear, Rotator cuff injury, Shoulder pain, Shoulder injury
Medical subject headings: Rotator Cuff Injuries, Shoulder Pain, Shoulder Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PRFMDevice
Double RowProcedure or surgery

Study groups in NCT02256891
Study group	Role	What they receive
Double Row	Experimental	Double Row Receives: Procedure: Double Row
Double Row with PRFM	Experimental	Double Row with PRFM Receives: Device: PRFM; Procedure: Double Row

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline
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.
Measured: 6 months
Return to Function
Western Ontario Rotator Cuff Index
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Dec 2015

First posted6 Oct 2014 (estimated)
Study startJul 2011
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02256891
Sponsor's protocol ID: 04100-11-C
Acronym: RCRPRFM
Status last verified: Oct 2015
First submitted: 4 Aug 2014
Last updated: 9 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rotator Cuff Tear trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02256891
Acronym / sponsor ID: RCRPRFM / 04100-11-C
Conditions: Rotator Cuff Tear
Keywords: Rotator cuff tear, Rotator cuff injury, Shoulder pain, Shoulder injury
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: HealthPartners InstituteUniversity, hospital or other
Collaborators: Musculoskeletal Transplant Foundation
Study start: Jul 2011
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 6 Oct 2014 (estimated)
Results: Posted 9 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Double Row	Experimental	Procedure: Double RowDouble Row
Double Row with PRFM	Experimental	Device: PRFM, Procedure: Double RowDouble Row with PRFM

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (18 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PRFM	Device	Double Row with PRFM
Double Row	Procedure or surgery	Double Row, Double Row with PRFM

Primary outcome

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.
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.
Return to Function
Time frame: 24 months
Western Ontario Rotator Cuff Index

Results and safety

Results posted to the registry on 9 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Double Row	55	43
Double Row With PRFM	42	29

Primary outcome: Return to Function

Time frame: Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Double Row n = 44	Double Row With PRFM n = 32
Value	1257.45 (396.07)	1106.31 (393.78)

Primary outcome: Return to Function

Time frame: 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Double Row n = 40	Double Row With PRFM n = 31
Value	371.38 (312.18)	297.13 (221.21)

Primary outcome: Return to Function

Time frame: 24 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Double Row n = 41	Double Row With PRFM n = 28
Value	174.8 (254.41)	103.11 (144.03)

Population analysed: 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 24 month measure than those that completed the entire study.

Adverse events

Time frame: 24 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Double Row	0 of 55 (0%)	9 of 55 (16.4%)	Not reported
Double Row With PRFM	0 of 42 (0%)	2 of 42 (4.8%)	Not reported

Limitations and caveats (from the sponsor): A disadvantage is the majority of the tears are small or medium sized. These have a higher intrinsic healing and as such may not require platelet augmentation to afford a successful outcome.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rotator Cuff Tear

Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Active, not recruiting
Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
Rotator Cuff Tear, Rotator Cuff Syndrome
Active, not recruiting
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
Rotator Cuff Tear Arthropathy, Repair of a Cuff Tear

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PRFM and Double Row in people with Rotator Cuff Tear, run by HealthPartners Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Return to Function (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02256891.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.