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| Name | Class |
|---|---|
| Academy of Finland | OTHER |
| Oulu University Hospital | OTHER |
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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.
Subgroup analyses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotator cuff repair | Active Comparator | Surgery following a 3 months period of active non-operative treatment |
|
| Conservative treatment | Active Comparator | Physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotator cuff repair | Procedure | Rotator cuff repair + physical therapy according to a standardized protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain (VAS) and objective shoulder function (Constant score) | VAS (0 to 100 mm), Constant score (0 to 100 points) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain (VAS) and objective shoulder function (Constant score) | VAS (0 to 100 mm), Constant score (0 to 100 points) | 3 months |
| Change in pain (VAS) and objective shoulder function (Constant score) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juha Paloneva, MD, PhD | Central Finland Health Care District, University of Eastern Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Helsinki | Helsinki | Finland | ||||
| Central Finland Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17179786 | Background | 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. | |
| 26537160 | Background | 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. |
| Label | URL |
|---|---|
| Clinical Musculoskeletal Diseases Research Group internet pages | View source |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Conservative treatment | Procedure | Physiotherapy according to a standardized protocol |
|
|
VAS (0 to 100 mm), Constant score (0 to 100 points)
| 6 months |
| Change in pain (VAS) and objective shoulder function (Constant score) | VAS (0 to 100 mm), Constant score (0 to 100 points) | 12 months |
| Change in pain (VAS) and objective shoulder function (Constant score) | VAS (0 to 100 mm), Constant score (0 to 100 points) | 5 years |
| Jyväskylä |
| FIN-40620 |
| Finland |
| Oulu University Hospital | Oulu | Finland |
| 24395315 | Background | 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. |
| 26189808 | Background | 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. |
| 25232074 | Background | 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. |
| 20044684 | Background | 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. |
| 26265152 | Background | 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. |
| 25340548 | Background | 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. |
| 33272959 | Derived | 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. |