Full Thickness Rotator Cuff TearNCT01557309
Clinical and Structural Outcome After Early Repair of the Traumatic Rotator Cuff Tear
An observational study of Full Thickness Rotator Cuff Tear, run by Helsingborgs Hospital at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Full Thickness Rotator Cuff Tear
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2010to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- trauma to the shoulder with sudden onset of symptoms
- asymptomatic shoulder before trauma
- mr positive for full thickness rotator cuff tear
Who cannot join
- fracture
- severe comorbidity
- more than 6 weeks after trauma
- glenohumeral degeneration signs or osteoarthritis on x-ray
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Orthopaedic Surgery, Helsingborg Hospital
Helsingborg, 25187
About this study
Official title: Arthroscopic Repair of Traumatic Rotator Cuff Tears. A Prospective Trial
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.
- Conditions
- Full Thickness Rotator Cuff Tear
- Keywords
- traumatic rotator cuff tear, arthroscopic rotator cuff repair, age, early rotator cuff repair
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Rotator Cuff Index (WORC)
Measured: Two years
Secondary outcomes (4)
Constant Shoulder Score (CS)
Measured: One year
standardised measure of health status with EQ-5D
Measured: Two years
cuff integrity
Measured: One year
Complications
Measured: within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startNov 2010
- Primary completionOct 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Full Thickness Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsingborgs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Knut Aagaard, MD, Lund University
- Investigators
- Karl Lunsjo, Ass Prof, Study director, Helsingborgs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557309
- Sponsor's protocol ID
- KAstudy2
- Status last verified
- Aug 2016
- First submitted
- 27 Jan 2012
- Last updated
- 17 Aug 2016
- Results posted
- No
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 6839586Lahteenmaki 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 17621294Bjornsson 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 21434791Petersen 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 20675154Sorensen 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 17169582Nho 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Repair of Traumatic Rotator Cuff Tears. A Prospective Trial
- ClinicalTrials.gov ID
- NCT01557309
- Acronym / sponsor ID
- KAstudy2
- Conditions
- Full Thickness Rotator Cuff Tear
- Keywords
- traumatic rotator cuff tear, arthroscopic rotator cuff repair, age, early rotator cuff repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Helsingborgs HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- trauma to the shoulder with sudden onset of symptoms
- asymptomatic shoulder before trauma
- mr positive for full thickness rotator cuff tear
Key exclusion criteria (4 listed)
- fracture
- severe comorbidity
- more than 6 weeks after trauma
- glenohumeral degeneration signs or osteoarthritis on x-ray
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Western Ontario Rotator Cuff Index (WORC)
Time frame: Two years
4 secondary outcomes
Constant Shoulder Score (CS)
Time frame: One year
standardised measure of health status with EQ-5D
Time frame: Two years
cuff integrity
Time frame: One year
Complications
Time frame: within one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Background: PubMed 6839586Bassett RW, Cofield RH. Acute tears of the rotator cuff. The timing of surgical repair. Clin Orthop Relat Res. 1983 May;(175):18-24.
- Background: PubMed 17621294Lahteenmaki R, Lawrence S. Public biotech 2006 - the numbers. Nat Biotechnol. 2007 Jul;25(7):729-37. doi: 10.1038/nbt0707-729. No abstract available.
- Background: PubMed 21434791Bjornsson 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.
- Background: PubMed 20675154Petersen 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.
- Background: PubMed 17169582Sorensen 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.
- Background: PubMed 19531660Nho 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.
Related trials for Full Thickness Rotator Cuff Tear
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Recruiting
Biceps Tenodesis With 360 Suture Anchor Versus Self Locking Tenodesis In the Absence of Rotator Cuff Tears
SLAP Lesion
RecruitingObservational study
Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant
Rotator Cuff Injuries
Recruiting
Cold and Compression After Rotator Cuff Repair (RCR)
High-grade Partial or Full Thickness Rotator Cuff Tears
RecruitingPhase 4
Bioinductive Patch for Full-Thickness Rotator Cuff Tears
Rotator Cuff Tears, Rotator Cuff Tear Arthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Lunsjo, Ass Prof study director
Helsingborgs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Full Thickness Rotator Cuff Tear, run by Helsingborgs Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Rotator Cuff Index (WORC) (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01557309, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.