Rotator Cuff Tear Clinical Trial
Official title:
Prospective Randomized Case-controlled Blinded Study of Single Versus Double Row Suture Anchor Repair in Medium to Large Rotator Cuff Tears
| Verified date | April 2011 |
| Source | Samsung Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Ministry for Health and Welfare |
| Study type | Observational |
The purpose of this study is to determine whether double row repair is better in healing
than traditional single row repair in arthroscopic rotator cuff repair.
Our null hypothesis is there are no differences in clinical and structural results
| Status | Completed |
| Enrollment | 71 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Rotator cuff tears - tear size between 2cm~4cm Exclusion Criteria: - Subscapularis tear requiring repair - open repair - any prior history of surgery on the affected shoulder - any fracture history around shoulder girdle(clavicle, humerus, acromion) - glenohumeral joint arthritis - inflammatory arthropathy |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Samsung Medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Samsung Medical Center |
Korea, Republic of,
Burks RT, Crim J, Brown N, Fink B, Greis PE. A prospective randomized clinical trial comparing arthroscopic single- and double-row rotator cuff repair: magnetic resonance imaging and early clinical evaluation. Am J Sports Med. 2009 Apr;37(4):674-82. doi: 10.1177/0363546508328115. Epub 2009 Feb 9. — View Citation
Charousset C, Grimberg J, Duranthon LD, Bellaiche L, Petrover D. Can a double-row anchorage technique improve tendon healing in arthroscopic rotator cuff repair?: A prospective, nonrandomized, comparative study of double-row and single-row anchorage techniques with computed tomographic arthrography tendon healing assessment. Am J Sports Med. 2007 Aug;35(8):1247-53. Epub 2007 Apr 23. — View Citation
Franceschi F, Ruzzini L, Longo UG, Martina FM, Zobel BB, Maffulli N, Denaro V. Equivalent clinical results of arthroscopic single-row and double-row suture anchor repair for rotator cuff tears: a randomized controlled trial. Am J Sports Med. 2007 Aug;35(8):1254-60. Epub 2007 Jun 6. — View Citation
Grasso A, Milano G, Salvatore M, Falcone G, Deriu L, Fabbriciani C. Single-row versus double-row arthroscopic rotator cuff repair: a prospective randomized clinical study. Arthroscopy. 2009 Jan;25(1):4-12. doi: 10.1016/j.arthro.2008.09.018. Epub 2008 Nov 1. — View Citation
Mazzocca AD, Millett PJ, Guanche CA, Santangelo SA, Arciero RA. Arthroscopic single-row versus double-row suture anchor rotator cuff repair. Am J Sports Med. 2005 Dec;33(12):1861-8. Epub 2005 Oct 6. — View Citation
Park JY, Lhee SH, Choi JH, Park HK, Yu JW, Seo JB. Comparison of the clinical outcomes of single- and double-row repairs in rotator cuff tears. Am J Sports Med. 2008 Jul;36(7):1310-6. doi: 10.1177/0363546508315039. Epub 2008 Apr 15. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Retear rate in each group(single row repair group and double row repair group) | MRI after 6 months from surgery | No |
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