Cuff Injury, Rotator, Arthroscopic Surgical Procedures, Stem Cell, PRP
Conditions
Brief summary
The goal of this observational study is to evaluate the clinical and radiographic outcomes of the biological enhancement of the arthroscopic rotator cuff repair with stem cells from the acromial bursa and PRP in individuals who undergo arthroscopic cuff repair The main question it aims to answer is: Do the stems cells from the acromial bursa and PRP promote healing and produce better results in arthroscopic cuff repair? Researchers will compare this population to three others the first do bnot receive any biological enchancement, the second receive only stem cells and the third receive only PRP to see if there are any differences.
Interventions
BIOLOGICALSubacromial Bursa Tissue Reimplantation
Autologous minced subacromial bursal tissue harvested arthroscopically using a tissue collection device and applied at the bone-tendon interface immediately after rotator cuff repair.
PROCEDUREArthroscopic Rotator Cuff Repair
Standard arthroscopic repair of full-thickness isolated supraspinatus tendon tears using suture anchors.
BIOLOGICALPlatelet-Rich Plasma (PRP) Injections
Autologous platelet-rich plasma prepared from preoperatively collected peripheral blood and applied at the bone-tendon interface immediately after repair completion.
OTHERNormal Saline (0.9% NaCl)
Three milliliters of sterile normal saline applied at the bone-tendon interface immediately after arthroscopic rotator cuff repair as placebo comparator.
Sponsors
National and Kapodistrian University of Athens
Athens Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients aged ≥18 years. Patients undergoing arthroscopic rotator cuff repair. Patients with a full-thickness, isolated, primary tear of the supraspinatus tendon. Patients considered eligible for arthroscopic rotator cuff repair using suture anchors. Ability and willingness to provide written informed consent. Willingness and ability to comply with the study protocol and scheduled follow-up visits.
Exclusion criteria
Partial-thickness rotator cuff tears. Massive or irreparable rotator cuff tears. Revision rotator cuff repair. Concomitant tears of the subscapularis tendon, infraspinatus tendon, long head of the biceps tendon requiring surgical treatment, or glenoid labrum. Previous surgery on the affected shoulder. Glenohumeral osteoarthritis or advanced cuff tear arthropathy. Active infection or systemic inflammatory disease affecting the shoulder. Use of other biological augmentation techniques during surgery, such as collagen patch, stem cells, bone marrow aspirate concentrate, or other scaffold-based augmentation. Inability to provide informed consent. Inability or unwillingness to comply with the postoperative rehabilitation protocol or follow-up schedule.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Outcome Assessed by Constant-Murley Score and ASES Score | The primary outcome measure will be the functional outcome of the shoulder assessed using the Constant-Murley Score and the American Shoulder and Elbow Surgeons (ASES) score at 3, 6, and 12 months postoperatively. Both scores are validated instruments ev | The primary outcome measure will be the functional outcome of the shoulder assessed using the Constant-Murley Score and the American Shoulder and Elbow Surgeons (ASES) score at 3, 6, and 12 months postoperatively. Both scores are validated instruments evaluating pain, daily activities, and shoulder function, with higher scores indicating better clinical outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rotator Cuff Tendon Integrity Assessed by MRI (Sugaya Classification) | 12 months postoperatively | Tendon integrity will be evaluated using magnetic resonance imaging (MRI) at 12 months postoperatively. Repair integrity will be classified according to the Sugaya classification system and categorized to assess healing or re-tear. |
| Pain Intensity Assessed by Numeric Rating Scale (NRS) | 3, 6, and 12 months postoperatively | Postoperative pain will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain), at 3, 6, and 12 months postoperatively. |
| Health-Related Quality of Life Assessed by SF-12 | 3, 6, and 12 months postoperatively | Quality of life will be evaluated using the 12-Item Short Form Health Survey (SF-12) at 3, 6, and 12 months postoperatively. The questionnaire provides physical and mental health composite scores. |
| Patient Satisfaction | 3, 6, and 12 months postoperatively | Patient satisfaction will be assessed using a Numeric Rating Scale from 0 to 10 at 3, 6, and 12 months postoperatively, with higher scores indicating greater satisfaction. |
| Postoperative Complications and Retear Rate | Up to 12 months postoperatively | All postoperative complications and symptomatic retears will be recorded throughout the follow-up period. |
Contacts
CONTACTANDRIANI ZAFEIRI, MEDICAL DOCTOR
PRINCIPAL_INVESTIGATORAndriani Zafeiri
Outcome results
None listed