Clinical trial NCT01039571: Single Versus Double Row Suture Anchor Repair in Medium to Large Rotator Cuff Tears
Official title: Prospective Randomized Case-controlled Blinded Study of Single Versus Double Row Suture Anchor Repair in Medium to Large Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: rotator cuff tear
arthroscopic repair
single row repair
double row repair
retear rate
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-12-25
Enrollment: 71
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rotator cuff tear patients

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Retear rate in each group(single row repair group and double row repair group)
timeFrame: MRI after 6 months from surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
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.
citation: 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.
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. doi: 10.1177/0363546507302218. Epub 2007 Jun 6.
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. doi: 10.1177/0363546507301661. Epub 2007 Apr 23.
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. doi: 10.1177/0363546505279575. Epub 2005 Oct 6.
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.