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

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 Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Rotator Cuff Tear

Being tested

Conventional arthroscopic rotator cuff repair, Arthroscopic rotator cuff repair with PRP

Medical subject headings

Rotator Cuff Injuries

What participants receive

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

• Conventional arthroscopic rotator cuff repairProcedure or surgery

  • 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 PRPProcedure or surgery

  • 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.

What is being measured

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

1. 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.

   Measured: postoperative 9months

Timeline

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

1. First posted10 Nov 2010 (estimated)
2. Study startJul 2009
3. Primary completionOct 2012
4. Study completionDec 2012

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
• More trials run by Seoul National University HospitalThe sponsor's other registered studies.
• 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.