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CompletedNCT01557309Updated Aug 17, 2016

Clinical and Structural Outcome After Early Repair of the Traumatic Rotator Cuff Tear

An observational study in Full Thickness Rotator Cuff Tear, sponsored by Helsingborgs Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-08-17.

Sponsored by Helsingborgs Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

There exists controversy in the current literature regarding timing for surgical repair of traumatic rotator cuff tears. We have seen no prospective studies describing the progression of shoulder function improvement the first year after arthroscopic rotator cuff repair.

We hypothesize that early arthroscopic repair of traumatic rotator cuff tears yields successful functional and structural outcomes but there will be a progression of shoulder function improvement during the hole first postoperative year.

02

Conditions studied

  • Full Thickness Rotator Cuff Tear

Keywords

  • traumatic rotator cuff tear
  • arthroscopic rotator cuff repair
  • age
  • early rotator cuff repair
03

In context

Lead sponsor

Helsingborgs Hospital is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (actual)
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Western Ontario Rotator Cuff Index (WORC)

    Time frame: Two years

Secondary outcomes

  1. Constant Shoulder Score (CS)

    Time frame: One year

  2. standardised measure of health status with EQ-5D

    Time frame: Two years

  3. cuff integrity

    Time frame: One year

  4. Complications

    Time frame: within one year

07

Study locations

1 site
  • Department of Orthopaedic Surgery, Helsingborg Hospital
    Helsingborg, 25187, Sweden
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References and documents

Publications

  • Bassett RW, Cofield RH. Acute tears of the rotator cuff. The timing of surgical repair. Clin Orthop Relat Res. 1983 May;(175):18-24. PubMed 6839586 ↗
  • 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. PubMed 17621294 ↗
  • 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. PubMed 21434791 ↗
  • 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. PubMed 20675154 ↗
  • 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. PubMed 17169582 ↗
  • 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. PubMed 19531660 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2010, a primary completion of Oct 2013 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2012
First posted
Mar 19, 2012
Start
Nov 2010
Primary completionActual
Oct 2013
CompletionActual
Apr 2014
Last update
Aug 17, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01557309
Lead sponsor
Helsingborgs Hospital
Responsible party
Knut Aagaard, MD (MD., Lund University) — Principal investigator
First posted
Mar 19, 2012
Start date
Nov 2010
Primary completion
Oct 2013
Completion
Apr 2014
Last update
Aug 17, 2016

Study contacts

Karl Lunsjo, Ass Prof
study director · Helsingborgs Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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