Operative Versus Non-operative Management of Rotator Cuff Tear

NCT00695981 | Active Not Recruiting DMC

• 1 other identifier: B07103-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Rotator Cuff Tear

Keywords

Rotator cuff; Arthroscopic surgery; Open surgery; Physiotherapy; Physical therapy; Effectiveness; RCT; cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Change in pain (VAS) and objective shoulder function (Constant score)

  VAS (0 to 100 mm), Constant score (0 to 100 points)

  24 months

Secondary Outcomes (4)

• Change in pain (VAS) and objective shoulder function (Constant score)

  3 months

• Change in pain (VAS) and objective shoulder function (Constant score)

  6 months

• Change in pain (VAS) and objective shoulder function (Constant score)

  12 months

• Change in pain (VAS) and objective shoulder function (Constant score)

  5 years

Study Arms (2)

Rotator cuff repair

ACTIVE COMPARATOR

Surgery following a 3 months period of active non-operative treatment

Procedure: Rotator cuff repair

Conservative treatment

ACTIVE COMPARATOR

Physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment

Procedure: Conservative treatment

Interventions

Rotator cuff repair PROCEDURE

Rotator cuff repair + physical therapy according to a standardized protocol

Also known as: Arthroscopic or open rotator cuff repair

Rotator cuff repair

Conservative treatment PROCEDURE

Physiotherapy according to a standardized protocol

Also known as: Physical therapy, Non-operative treatment

Conservative treatment

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Finland Hospital District: lead
• Academy of Finland: collaborator
• Oulu University Hospital: collaborator

Study Sites (3)

University of Helsinki

Helsinki, Finland

Location

Central Finland Hospital

Jyväskylä, FIN-40620, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Related Publications (9)

• 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.

  PMID: 17179786 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.

  PMID: 26537160 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.

  PMID: 24395315 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.

  PMID: 26189808 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.

  PMID: 25232074 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.

  PMID: 20044684 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.

  PMID: 26265152 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.

  PMID: 25340548 BACKGROUND

• 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.

  PMID: 33272959 DERIVED

Related Links

• Clinical Musculoskeletal Diseases Research Group internet pages

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Conservative Treatment; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Juha Paloneva, MD, PhD

  Central Finland Health Care District, University of Eastern Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, PhD

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: June 12, 2008
• Study Start: June 1, 2008
• Primary Completion: January 1, 2017
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

FI (3)