NCT01557309

Brief Summary

The optimal timing for surgical repair of traumatic rotator cuff tears is controversial. Today there are no prospective studies investigating the short to mid-term outcome after early arthroscopic repair of traumatic rotator cuff tears and the Swedish National Musculoskeletal Competence Centre requests more research to this subject. The investigators will follow 60 patients with acute rotator cuff tear undergoing early rotator cuff repair during the first year after surgery. The investigators hypothesise that the outcome after rotator cuff repair is good.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2010

Typical duration 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

November 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 19, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

2.9 years

First QC Date

January 27, 2012

Last Update Submit

August 16, 2016

Conditions

Full Thickness Rotator Cuff Tear

Keywords

traumatic rotator cuff teararthroscopic rotator cuff repairageearly rotator cuff repair

Outcome Measures

Primary Outcomes (1)

  • Western Ontario Rotator Cuff Index (WORC)

    Two years

Secondary Outcomes (4)

  • Constant Shoulder Score (CS)

    One year

  • standardised measure of health status with EQ-5D

    Two years

  • cuff integrity

    One year

  • Complications

    within one year

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A prospective trial analysing the results after early arthroscopic repair of the traumatic rotator cuff tear. Every consecutive patient between Nov 2010 and Oct 2013 who fulfill the inclusion criteria are asked to participate after oral and written information. With a population of 250.000 we approximate an enrollment of 60 participants.

You may qualify if:

  • trauma to the shoulder with sudden onset of symptoms
  • asymptomatic shoulder before trauma
  • mr positive for full thickness rotator cuff tear

You may not qualify if:

  • fracture
  • severe comorbidity
  • more than 6 weeks after trauma
  • glenohumeral degeneration signs or osteoarthritis on x-ray

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedic Surgery, Helsingborg Hospital

Helsingborg, 25187, Sweden

Location

Related Publications (6)

  • Bassett RW, Cofield RH. Acute tears of the rotator cuff. The timing of surgical repair. Clin Orthop Relat Res. 1983 May;(175):18-24.

    PMID: 6839586BACKGROUND

  • Lahteenmaki R, Lawrence S. Public biotech 2006 - the numbers. Nat Biotechnol. 2007 Jul;25(7):729-37. doi: 10.1038/nbt0707-729. No abstract available.

    PMID: 17621294BACKGROUND

  • Bjornsson HC, Norlin R, Johansson K, Adolfsson LE. The influence of age, delay of repair, and tendon involvement in acute rotator cuff tears: structural and clinical outcomes after repair of 42 shoulders. Acta Orthop. 2011 Apr;82(2):187-92. doi: 10.3109/17453674.2011.566144. Epub 2011 Mar 24.

    PMID: 21434791BACKGROUND

  • Petersen SA, Murphy TP. The timing of rotator cuff repair for the restoration of function. J Shoulder Elbow Surg. 2011 Jan;20(1):62-8. doi: 10.1016/j.jse.2010.04.045. Epub 2010 Aug 1.

    PMID: 20675154BACKGROUND

  • Sorensen AK, Bak K, Krarup AL, Thune CH, Nygaard M, Jorgensen U, Sloth C, Torp-Pedersen S. Acute rotator cuff tear: do we miss the early diagnosis? A prospective study showing a high incidence of rotator cuff tears after shoulder trauma. J Shoulder Elbow Surg. 2007 Mar-Apr;16(2):174-80. doi: 10.1016/j.jse.2006.06.010. Epub 2006 Dec 13.

    PMID: 17169582BACKGROUND

  • Nho SJ, Adler RS, Tomlinson DP, Allen AA, Cordasco FA, Warren RF, Altchek DW, MacGillivray JD. Arthroscopic rotator cuff repair: prospective evaluation with sequential ultrasonography. Am J Sports Med. 2009 Oct;37(10):1938-45. doi: 10.1177/0363546509335764. Epub 2009 Jun 16.

    PMID: 19531660BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peroperatively retained rotator cuff biopsy.

Study Officials

  • Karl Lunsjo, Ass Prof

    Helsingborgs Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.

Study Record Dates

First Submitted

January 27, 2012

First Posted

March 19, 2012

Study Start

November 1, 2010

Primary Completion

October 1, 2013

Study Completion

April 1, 2014

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

SE(1)