Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears

* The purpose of this study is to compare the clinical and anatomical outcomes of rotator cuff repair with Platelet-Rich Plasma(PRP) and conventional rotator cuff repair in treatment of large to massive rotator cuff tears. * PRP application to arthroscopic rotator cuff repair would accelerate recovery after arthroscopic rotator cuff repair in terms of pain relief, functional outcomes, overall satisfaction, and enhance structural integrity of repaired tendon.

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Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine

Seoul, 156-707, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

large to massive rotator cuff tear as a determined by clinical examination and MR prior to surgery.

Exclusion criteria

previous history of shoulder surgery
acute trauma
chronic dislocation
pyogenic infection
rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head
showed abnormal serological test results
thrombocytopenia (platelets less than 15000 per microliter)
had been received anti-platelet medication
psychiatric problems that precludes informed consent or inability to read or write
other serious problems that preclude participation of the study

Treatment and study plan

Conventional arthroscopic rotator cuff repair

Procedure

Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table.
The surgical area was prepared and draped with Betadine.
Small stab incisions were made in the creation of 4-5 portals as needed.
A scope was explored via the arthroscopic portal into the GH joint & subacromial space.
Repair of full thickness rotator cuff tear was done with suture anchors.
The skin was closed with Nylon or medical staples.
Sterile dressing was applied on surgical wound.

Arthroscopic rotator cuff repair with PRP

Procedure

Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table.
The surgical area was prepared and draped with Betadine.
Small stab incisions were made in the creation of 4-5 portals as needed.
A scope was explored via the arthroscopic portal into the GH joint & subacromial space.
Repair of full thickness rotator cuff tear was done with suture anchors.
After tying sutures of the medial row, PRP gels were applied on the repair site.
The lateral row was secured using suture anchors.
The skin was closed with Nylon or medical staples.
Sterile dressing was applied on surgical wound.

Primary outcomes

structural integrity of repaired rotator cuff tendon

Time frame: postoperative 9months
To evaluate structural outcomes, magnetic resonance(MR)imaging or computed tomography arthrography were used at minimum postoperative 9months.

The structural integrity was evaluated using Sugaya's method;
- type I, sufficient thickness with homogenously low intensity
- type II, insufficient thickness partial high intensity
- type III, insufficient thickness without discontinuity (thinned cuff)
- type IV, presence of minor discontinuity
- type V, presence of a major discontinuity
Type I, II, and III were considered as healed, while type IV, and V were considered as retear.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears : A Randomized Controlled Trial

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Nov 10, 2010
Registry last updated: Feb 27, 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.

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