NCT01039571

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 25, 2009

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

April 22, 2011

Status Verified

April 1, 2011

Enrollment Period

5 years

First QC Date

December 23, 2009

Last Update Submit

April 21, 2011

Conditions

Rotator Cuff Tear

Keywords

rotator cuff teararthroscopic repairsingle row repairdouble row repairretear rate

Outcome Measures

Primary Outcomes (1)

  • Retear rate in each group(single row repair group and double row repair group)

    MRI after 6 months from surgery

Interventions

double row repairPROCEDURE

double row repair for torn rotator cuff were performed to compare with the conventional single row repair

Also known as: dual row repair

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Rotator cuff tear patients

You may qualify if:

  • Rotator cuff tears
  • tear size between 2cm\~4cm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (6)

  • 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.

    PMID: 19111212BACKGROUND

  • 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.

    PMID: 19204365BACKGROUND

  • 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.

    PMID: 17554104BACKGROUND

  • 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.

    PMID: 17452513BACKGROUND

  • 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.

    PMID: 16210578BACKGROUND

  • 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.

    PMID: 18413680BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 23, 2009

First Posted

December 25, 2009

Study Start

January 1, 2005

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

April 22, 2011

Record last verified: 2011-04

Locations

KR(1)