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

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238302
• Other study ID #: BRM-10-03
• Status: Completed
• Phase: N/A
• First received: November 8, 2010
• Last updated: February 23, 2017
• Start date: July 2009
• Est. completion date: December 2012

Study information

• Verified date: February 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Tear

Intervention

Procedure:
• Conventional arthroscopic rotator cuff repair
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
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.

Locations

Country	Name	City	State
Korea, Republic of	Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	structural integrity of repaired rotator cuff tendon	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.	postoperative 9months