Rotator Cuff Tear Clinical Trial
Official title:
Treatment of Small Acute Full-thickness tears-a Prospective Randomised Controlled Trial
The purpose of this project is to compare operative repair of traumatically torn rotator cuff tendon with physiotherapy in a randomized prospective study.
In clinical practice most patients with a traumatic acute rotator cuff tear are treated with
operative repair. The results of surgery are in most cases good but there are also good
results in the literature from conservative treatment. So far there has been no prospective
randomized comparison between the two treatments. When it comes to degenerative
non-traumatic tears, level 1 and 2 studies have not been able to show the superiority of
surgery.
This study takes place in 2 clinics in Sweden (Linköping and Kalmar). Patients who have no
previous shoulder conditions, a trauma to the shoulder and pain and/or inability to lift
their arm will undergo magnetic resonance imaging (MRI). If this indicates a full-thickness
rotator cuff tear of the cranial part of the rotator cuff the patient will be randomized to
surgery or physiotherapy. Surgical intervention is mini-open repair.
Follow-up takes place at 3 months, 6 months and 12 months with patient scores taken by a
blinded independent physiotherapist. At 12 months a new MRI is conducted as well.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
| Completed |
NCT03663036 -
Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis
|
N/A | |
| Suspended |
NCT03290196 -
The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics
|
Phase 4 | |
| Active, not recruiting |
NCT03091075 -
Oxandrolone Rotator Cuff Trial
|
N/A | |
| Completed |
NCT03380533 -
Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair
|
Phase 2/Phase 3 | |
| Completed |
NCT04566939 -
A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine
|
||
| Active, not recruiting |
NCT02716441 -
Rotator Cuff Failure With Continuity
|
||
| Completed |
NCT03540030 -
Opioid-Free Shoulder Arthroplasty
|
Phase 4 | |
| Completed |
NCT02298023 -
Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)
|
Phase 2 | |
| Completed |
NCT02850211 -
A Selective COX-2 Inhibitor Provides Pain Control But Hinders Healing Following Arthroscopic Rotator Cuff Repair
|
Phase 4 | |
| Completed |
NCT01383239 -
Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs
|
N/A | |
| Completed |
NCT01459536 -
Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear
|
N/A | |
| Completed |
NCT01170312 -
Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation
|
N/A | |
| Completed |
NCT01204606 -
Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)
|
N/A | |
| Terminated |
NCT00936559 -
Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair
|
Phase 1 | |
| Completed |
NCT00852657 -
Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff
|
N/A | |
| Active, not recruiting |
NCT00182299 -
An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS
|
Phase 4 | |
| Recruiting |
NCT06120998 -
Quality of Life After Arthroscopic Rotator Cuff Repair
|
||
| Completed |
NCT05897866 -
Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM)
|
N/A | |
| Completed |
NCT02644564 -
Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries
|
N/A |