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Rotator Cuff TearNCT00695981

Operative Versus Non-operative Management of Rotator Cuff Tear

A study testing Rotator cuff repair and Conservative treatment in people with Rotator Cuff Tear, run by Central Finland Hospital District at 3 sites in Finland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Rotator Cuff Tear
What is being tested?
Rotator cuff repair and Conservative treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesFinland
Study dates
Jun 2008to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • progressive malign disease
  • adhesive capsulitis
  • high-energy trauma before symptoms
  • cervical syndrome
  • shoulder instability

Trial locations and contacts

3 sites in 1 country.

Finland3 sites

  • University of Helsinki

    Helsinki

  • Central Finland Hospital

    Jyväskylä, FIN-40620

  • Oulu University Hospital

    Oulu

Other trials in Finland

About this study

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

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.

Read the 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
Being tested
Rotator cuff repair, Conservative treatment
Keywords
Rotator cuff, Arthroscopic surgery, Open surgery, Physiotherapy, Physical therapy, Effectiveness, RCT, cost-effectiveness
Medical subject headings
Rotator Cuff Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rotator cuff repairProcedure or surgery

    Also called Arthroscopic or open rotator cuff repair

    Rotator cuff repair + physical therapy according to a standardized protocol

  • Conservative treatmentProcedure or surgery

    Also called Physical therapy, Non-operative treatment

    Physiotherapy according to a standardized protocol

Study groups in NCT00695981
Study groupRoleWhat they receive
Rotator cuff repairActive comparatorSurgery following a 3 months period of active non-operative treatment
Receives: Procedure: Rotator cuff repair
Conservative treatmentActive comparatorPhysiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment
Receives: Procedure: Conservative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 24 months

Secondary outcomes (4)

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

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

    Measured: 3 months

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

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

    Measured: 6 months

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

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

    Measured: 12 months

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

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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJan 2017
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00695981
Sponsor's protocol ID
B07103-2
Status last verified
Aug 2024
First submitted
17 Mar 2008
Last updated
22 Aug 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 17179786

  • 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.

    PubMed 26537160

  • 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.

    PubMed 24395315

  • 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.

    PubMed 26189808

  • 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.

    PubMed 25232074

  • 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.

    PubMed 20044684

  • 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.

    PubMed 26265152

  • 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.

    PubMed 25340548

  • 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.

    PubMed 33272959

Questions about this trial

What is this clinical trial studying?

A study testing Rotator cuff repair and Conservative treatment in people with Rotator Cuff Tear, run by Central Finland Hospital District at 3 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain (VAS) and objective shoulder function (Constant score) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00695981, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.

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