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Purpose: To assess whether the use of platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair. Hypothesis: Platelet rich plasma used as an adjuvant to arthroscopic rotator cuff repairs decrease the rate of retears.
Platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthroscopic rotator cuff repair and platelet rich plasma | Experimental | A standard double-row arthroscopic rotator cuff repair will be performed and at the end of the procedure 10 ml of autologous platelet-rich plasma will be placed under direct vision at the tendon-bone interface. |
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| Arthroscopic rotator cuff repair | Active Comparator | A standard double-row arthroscopic rotator cuff repair will be performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic rotator cuff repair | Procedure | A double-row rotator cuff repair will be performed. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of re-tear rates between groups. | Postoperative MRI to assess the structural integrity of the repaired rotator cuff. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From baseline in shoulder functional scores at 3, 6 and 12 months | The ASES score (American Shoulder and Elbow Surgeons) and the Constant score will be used. Both scores assess the general function of the shoulder in different activities of daily life, global mobility of the shoulder and pain with usual tasks. They are scores ranging from 0 to 100. Both scores are validated and are the reference scores for clinical research on rotator cuff pathology |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luciano Rossi, MD | Hospital Italiano de Buenos Aires | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano de Buenos Aires | CABA | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38587033 | Derived | Rossi LA, Gorodischer TD, Camino P, Brandariz RN, Tanoira I, Piuzzi NS, Ranalletta M. Leukocyte-Poor Platelet-Rich Plasma as an Adjuvant to Arthroscopic Rotator Cuff Repair Reduces the Retear Rate But Does Not Improve Functional Outcomes: A Double-Blind Randomized Controlled Trial. Am J Sports Med. 2024 May;52(6):1403-1410. doi: 10.1177/03635465241239062. Epub 2024 Apr 8. |
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We are planning on sharing the study protocol and the tables contaning all outcomes for every individual patient
2 years
The IPD may be requested to the principal investigator contacting him through e-mail at luciano.rossi@hospitalitaliano.org.ar
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| platelet rich plasma | Biological | A single dose of 10 ml of autologous platelet rich plasma at the bone-tendon interfase will be administered. |
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| baseline, 3, 6, and 12 months |
| Change From baseline in pain at 3, 6 and 12 months | The visual analog scale (VAS) will be used to assess the level of pain during activities of daily living. 0 will be considered as "no pain" and 10 as "the worst pain of his life." | baseline, 3, 6, and 12 months |
| Number of Participants With Treatment-Related Adverse Events | Adverse effects and postoperative complications will be recorded. | 3, 6, and 12 months |