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Operative Versus Non-operative Management of Rotator Cuff Tear

Primary Purpose

Rotator Cuff Tear

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Rotator cuff repair
Conservative treatment
Sponsored by
Central Finland Hospital District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Rotator cuff, Arthroscopic surgery, Open surgery, Physiotherapy, Physical therapy, Effectiveness, RCT, cost-effectiveness

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Helsinki
  • Central Finland Hospital
  • Oulu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rotator cuff repair

Conservative treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in pain (VAS) and objective shoulder function (Constant score)
VAS (0 to 100 mm), Constant score (0 to 100 points)

Secondary Outcome Measures

Change in pain (VAS) and objective shoulder function (Constant score)
VAS (0 to 100 mm), Constant score (0 to 100 points)
Change in pain (VAS) and objective shoulder function (Constant score)
VAS (0 to 100 mm), Constant score (0 to 100 points)
Change in pain (VAS) and objective shoulder function (Constant score)
VAS (0 to 100 mm), Constant score (0 to 100 points)
Change in pain (VAS) and objective shoulder function (Constant score)
VAS (0 to 100 mm), Constant score (0 to 100 points)

Full Information

First Posted
March 17, 2008
Last Updated
February 7, 2023
Sponsor
Central Finland Hospital District
Collaborators
Academy of Finland, Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00695981
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2008 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Finland Hospital District
Collaborators
Academy of Finland, Oulu University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
Rotator cuff, Arthroscopic surgery, Open surgery, Physiotherapy, Physical therapy, Effectiveness, RCT, cost-effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rotator cuff repair
Arm Type
Active Comparator
Arm Description
Surgery following a 3 months period of active non-operative treatment
Arm Title
Conservative treatment
Arm Type
Active Comparator
Arm Description
Physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment
Intervention Type
Procedure
Intervention Name(s)
Rotator cuff repair
Other Intervention Name(s)
Arthroscopic or open rotator cuff repair
Intervention Description
Rotator cuff repair + physical therapy according to a standardized protocol
Intervention Type
Procedure
Intervention Name(s)
Conservative treatment
Other Intervention Name(s)
Physical therapy, Non-operative treatment
Intervention Description
Physiotherapy according to a standardized protocol
Primary Outcome Measure Information:
Title
Change in pain (VAS) and objective shoulder function (Constant score)
Description
VAS (0 to 100 mm), Constant score (0 to 100 points)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change in pain (VAS) and objective shoulder function (Constant score)
Description
VAS (0 to 100 mm), Constant score (0 to 100 points)
Time Frame
3 months
Title
Change in pain (VAS) and objective shoulder function (Constant score)
Description
VAS (0 to 100 mm), Constant score (0 to 100 points)
Time Frame
6 months
Title
Change in pain (VAS) and objective shoulder function (Constant score)
Description
VAS (0 to 100 mm), Constant score (0 to 100 points)
Time Frame
12 months
Title
Change in pain (VAS) and objective shoulder function (Constant score)
Description
VAS (0 to 100 mm), Constant score (0 to 100 points)
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juha Paloneva, MD, PhD
Organizational Affiliation
Central Finland Health Care District, University of Eastern Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Helsinki
City
Helsinki
Country
Finland
Facility Name
Central Finland Hospital
City
Jyväskylä
ZIP/Postal Code
FIN-40620
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17179786
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.
Results Reference
background
PubMed Identifier
26537160
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.
Results Reference
background
PubMed Identifier
24395315
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.
Results Reference
background
PubMed Identifier
26189808
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.
Results Reference
background
PubMed Identifier
25232074
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.
Results Reference
background
PubMed Identifier
20044684
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.
Results Reference
background
PubMed Identifier
26265152
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.
Results Reference
background
PubMed Identifier
25340548
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.
Results Reference
background
PubMed Identifier
33272959
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.
Results Reference
derived
Links:
URL
http://www.ksshp.fi/musculoskeletalresearch
Description
Clinical Musculoskeletal Diseases Research Group internet pages

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Operative Versus Non-operative Management of Rotator Cuff Tear

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