Health Condition 1: M751- Rotator cuff tear or rupture, notspecified as traumatic
Conditions
Interventions
Intervention1: Human amniotic membrane augmented rotator cuff repair: Routine technique of arthroscopic rotator cuff repair supplemented by human amniotic membrane at last step. Duration - one time su
Sponsors
RAGULAJAY B G
Eligibility
Inclusion criteria
Inclusion criteria: Recipient Inclusion criteria (patients undergoing rotator cuff surgery) 1. Partial/full thickness rotator cuff tear 2. All traumatic tears 3. Degenerative tears with failed conservative management Donor inclusion criteria (from whom amniotic membrane will be harvested) Healthy, consenting mothers 18-35 years of age undergoing elective lower segment caesarean section (LSCS) at term (37 weeks gestation or more), with two documented negative serological screenings for HIV, HBsAg, and HCV, one during the first trimester, and one within 7 days prior to delivery
Exclusion criteria
Exclusion criteria: Recipient exclusion criteria 1. Irreparable tears 2. Associated glenohumeral arthritis/cuff tear arthropathy 3. Prior shoulder infection or surgery including revision rotator cuff surgery 4. Any pathology that may influence the assessment of outcome (Eg. neurological disorder, prior fracture or dislocation of shoulder etc.,) Donor exclusion criteria (from whom amniotic membrane will not be harvested) 1. Vaginal delivery 2. Emergency caesarean section 3. Any chronic infection or immune disorder 4. Any blood or blood product transfusion during pregnancy after the first serology test 5. Any history of high risk behaviour (intravenous drug abuse, multiple partners, sexually transmitted disease) 6. Preterm delivery (less than 37 weeks) 7. Meconium-stained liquor, intrauterine fetal demise, or premature rupture of membranes 8. Evidence or suspicion of chorioamnionitis, prolonged labor, or maternal infection 9. Suspicious gross appearance of membrane 10. Inadequate or missing serologic documentation
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Structural tendon healing between the two groups based on MRI findings using Sugaya classificationTimepoint: 9 months after surgery | — |
Primary
| Measure | Time frame |
|---|---|
| Functional outcomes between the two groups using American shoulder and elbow surgeon (ASES) score and Shoulder Pain and Disability Index (SPADI)Timepoint: Before surgery, time 0 and 9 months after surgery | — |
Countries
India
Contacts
Public ContactRagulajay B G
All India Institute of Medical Sciences, Rishikesh
Outcome results
None listed