Clinical trial NCT00695981: Operative Versus Non-operative Management of Rotator Cuff Tear
Official title: The Effectiveness and Cost-Effectiveness of Operative and Non-operative Management of Rotator Cuff Tear
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: Rotator cuff
Arthroscopic surgery
Open surgery
Physiotherapy
Physical therapy
Effectiveness
RCT
cost-effectiveness
Lead sponsor: Central Finland Hospital District
Sponsor class: OTHER
Collaborators: name: Academy of Finland
name: Oulu University Hospital
First posted: 2008-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain (VAS) and objective shoulder function (Constant score)
timeFrame: 24 months
Secondary outcomes:
measure: Change in pain (VAS) and objective shoulder function (Constant score)
timeFrame: 3 months
measure: Change in pain (VAS) and objective shoulder function (Constant score)
timeFrame: 6 months
measure: Change in pain (VAS) and objective shoulder function (Constant score)
timeFrame: 12 months
measure: Change in pain (VAS) and objective shoulder function (Constant score)
timeFrame: 5 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki
city: Jyväskylä
country: Finland
facility: Central Finland Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Central Finland Health Care District, University of Eastern Finland
name: Juha Paloneva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.
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.
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.
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.
citation: Cederqvist S, Flinkkila T, Sormaala M, Ylinen J, Kautiainen H, Irmola T, Lehtokangas H, Liukkonen J, Pamilo K, Ridanpaa T, Sirnio K, Leppilahti J, Kiviranta I, Paloneva J. Non-surgical and surgical treatments for rotator cuff disease: a pragmatic randomised clinical trial with 2-year follow-up after initial rehabilitation. Ann Rheum Dis. 2021 Jun;80(6):796-802. doi: 10.1136/annrheumdis-2020-219099. Epub 2020 Dec 3.