Rotator Cuff TearNCT01458665
Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma (PRP) in Medium to Large Rotator Cuff Tears
A study testing Conventional arthroscopic rotator cuff repair and Arthroscopic rotator cuff repair with PRP in people with Rotator Cuff Tear, run by Seoul National University Hospital at 1 site in South Korea.
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 medium to large rotator cuff tears. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Conventional arthroscopic rotator cuff repair and Arthroscopic rotator cuff repair with PRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- medium to large rotator cuff tear as a determined by clinical examination and MR prior to surgery.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul, 156-707
About this study
Official title: Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma (PRP) in Medium to Large Rotator Cuff Tears: A Randomized Controlled Trial
- 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 medium to large 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | Not described Receives: Procedure: Arthroscopic rotator cuff repair with PRP |
| Conventional group | Placebo comparator | Not described Receives: Procedure: Conventional arthroscopic rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant-Murley shoulder score
The Constant score assesses pain, function, ROM, and strength. Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points. The component scores are summated to achieve a maximum possible total score of 100.
Measured: Postoperative 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2013
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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyunchul Jo, Seoul National University Hospital
- Investigators
- Chris H. Jo, M.D., Ph.D, Principal investigator, Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458665
- Sponsor's protocol ID
- BRM-11-01
- Status last verified
- Jun 2014
- First submitted
- 21 Oct 2011
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma (PRP) in Medium to Large Rotator Cuff Tears: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01458665
- Acronym / sponsor ID
- BRM-11-01
- Conditions
- Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 medium to large 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Procedure: Arthroscopic rotator cuff repair with PRP |
| Conventional group | Placebo comparator | Procedure: Conventional arthroscopic rotator cuff repair |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- medium to large rotator cuff tear as a determined by clinical examination and MR prior to surgery.
Key exclusion criteria (10 listed)
- previous history of shoulder surgery
- acute trauma
- chronic dislocation
- pyogenic infection
- rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head
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 |
|---|---|---|
| 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. | Procedure or surgery | Conventional group |
| 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. | Procedure or surgery | PRP group |
Primary outcome
Constant-Murley shoulder score
Time frame: Postoperative 3months
The Constant score assesses pain, function, ROM, and strength. Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points. The component scores are summated to achieve a maximum possible total score of 100.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
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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.
Chris H. Jo, M.D., Ph.D principal investigator
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional arthroscopic rotator cuff repair and Arthroscopic rotator cuff repair with PRP in people with Rotator Cuff Tear, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 10 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 18 Jun 2014. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Constant-Murley shoulder score (time frame: Postoperative 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2014.