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NCT00695981 Clinical Trial

Operative Versus Non-operative Management of Rotator Cuff Tear

Rotator Cuff Tear Clinical Trial

Official title:
The Effectiveness and Cost-Effectiveness of Operative and Non-operative Management of Rotator Cuff Tear

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00695981
Other study ID # B07103-2
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 2008
Est. completion date June 2024

Study information
Verified date February 2024
Source Central Finland Hospital District
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims at determining the effectiveness and cost-effectiveness of surgical management of full-thickness rotator cuff tears compared to conservative treatment. The research setting is prospective, randomised, and controlled. The aim of the study is to search out evidence based data of indications for rotator cuff repair. The investigators also aim at offering patients the most efficient and effective treatment and reduce the number of operations that do not have sufficient effectiveness. The data obtained will facilitate developing guidelines for referrals to a specialist when rotator cuff tear is suspected. The investigators hypothesize that there are subgroups of patients suffering from rotator cuff tears that benefit from surgery whereas other subgroups are best treated conservatively.

Description:

Subgroup analyses: - age - sex - duration of symptoms - presence of trauma before symptoms - size of tear - degenerative findings - other findings in MRI or arthroscopy - type of operation - co-morbidities - occupation - pain (VAS) - objective shoulder function - activities of daily living

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date June 2024
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 35 Years and older
Eligibility Inclusion Criteria: - age over 35 years old - duration of symptoms at least three months despite of non-operative treatment - the patient accepts both treatment options (operative and conservative) - a full-thickness rotator cuff tear in MRI arthrography Exclusion Criteria: - previous shoulder operations - too high risk for operation - any disease or social problem reducing the ability to co-operate - rheumatoid arthritis - severe arthrosis of the glenohumeral or acromioclavicular joint - irreparable rotator cuff tear (including rotator cuff tear arthropathy) - progressive malign disease - adhesive capsulitis - high-energy trauma before symptoms - cervical syndrome - shoulder instability

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Rotator cuff repair
Rotator cuff repair + physical therapy according to a standardized protocol
• Conservative treatment
Physiotherapy according to a standardized protocol

Locations
Country Name City State
Finland University of Helsinki Helsinki
Finland Central Finland Hospital Jyväskylä
Finland Oulu University Hospital Oulu

Sponsors (3)
Lead Sponsor Collaborator
Central Finland Hospital District Academy of Finland, Oulu University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (8)

Kukkonen J, Joukainen A, Lehtinen J, Mattila KT, Tuominen EK, Kauko T, Aarimaa V. Treatment of non-traumatic rotator cuff tears: A randomised controlled trial with one-year clinical results. Bone Joint J. 2014 Jan;96-B(1):75-81. doi: 10.1302/0301-620X.96B1.32168. — View Citation

Kukkonen J, Joukainen A, Lehtinen J, Mattila KT, Tuominen EK, Kauko T, Aarimaa V. Treatment of Nontraumatic Rotator Cuff Tears: A Randomized Controlled Trial with Two Years of Clinical and Imaging Follow-up. J Bone Joint Surg Am. 2015 Nov 4;97(21):1729-37. doi: 10.2106/JBJS.N.01051. Erratum In: J Bone Joint Surg Am. 2016 Jan 6;98(1):e1. — View Citation

Lambers Heerspink FO, van Raay JJ, Koorevaar RC, van Eerden PJ, Westerbeek RE, van 't Riet E, van den Akker-Scheek I, Diercks RL. Comparing surgical repair with conservative treatment for degenerative rotator cuff tears: a randomized controlled trial. J Shoulder Elbow Surg. 2015 Aug;24(8):1274-81. doi: 10.1016/j.jse.2015.05.040. — View Citation

Moosmayer S, Lund G, Seljom U, Svege I, Hennig T, Tariq R, Smith HJ. Comparison between surgery and physiotherapy in the treatment of small and medium-sized tears of the rotator cuff: A randomised controlled study of 103 patients with one-year follow-up. J Bone Joint Surg Br. 2010 Jan;92(1):83-91. doi: 10.1302/0301-620X.92B1.22609. — View Citation

Moosmayer S, Lund G, Seljom US, Haldorsen B, Svege IC, Hennig T, Pripp AH, Smith HJ. Tendon repair compared with physiotherapy in the treatment of rotator cuff tears: a randomized controlled study in 103 cases with a five-year follow-up. J Bone Joint Surg Am. 2014 Sep 17;96(18):1504-14. doi: 10.2106/JBJS.M.01393. — View Citation

Oh LS, Wolf BR, Hall MP, Levy BA, Marx RG. Indications for rotator cuff repair: a systematic review. Clin Orthop Relat Res. 2007 Feb;455:52-63. doi: 10.1097/BLO.0b013e31802fc175. — View Citation

Paloneva J, Lepola V, Aarimaa V, Joukainen A, Ylinen J, Mattila VM. Increasing incidence of rotator cuff repairs--A nationwide registry study in Finland. BMC Musculoskelet Disord. 2015 Aug 12;16:189. doi: 10.1186/s12891-015-0639-6. — View Citation

Paloneva J, Lepola V, Karppinen J, Ylinen J, Aarimaa V, Mattila VM. Declining incidence of acromioplasty in Finland. Acta Orthop. 2015 Apr;86(2):220-4. doi: 10.3109/17453674.2014.977703. Epub 2014 Oct 23. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in pain (VAS) and objective shoulder function (Constant score) VAS (0 to 100 mm), Constant score (0 to 100 points) 24 months
Secondary Change in pain (VAS) and objective shoulder function (Constant score) VAS (0 to 100 mm), Constant score (0 to 100 points) 3 months
Secondary Change in pain (VAS) and objective shoulder function (Constant score) VAS (0 to 100 mm), Constant score (0 to 100 points) 6 months
Secondary Change in pain (VAS) and objective shoulder function (Constant score) VAS (0 to 100 mm), Constant score (0 to 100 points) 12 months
Secondary Change in pain (VAS) and objective shoulder function (Constant score) VAS (0 to 100 mm), Constant score (0 to 100 points) 5 years
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