NCT00852657

Brief Summary

The purpose of this study is to compare treatment benefits from surgical treatment by tendon repair and from physiotherapy for small and medium-sized rotator cuff tears.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2009

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

18.5 years

First QC Date

February 26, 2009

Last Update Submit

March 13, 2023

Conditions

Rotator Cuff Tear

Keywords

Rotator cuff tearsurgical repairPhysiotherapyTreatment benefitSurgery

Outcome Measures

Primary Outcomes (1)

  • Constant score

    baseline, 6 months, 1, 2, 5, 10, 15 years

Secondary Outcomes (3)

  • self report section of the American Shoulder and Elbow Surgeons score (ASES)

    baseline, 6 months, 1, 2, 5, 10, 15 years

  • Short Form 36 Health Survey (SF-36)

    baseline, 6 months, 1, 2, 5, 10, 15 years

  • Patient satisfaction

    1, 2, 5, 10, 15 years

Study Arms (2)

Surgical treatment

ACTIVE COMPARATOR

Open or mini-open tendon repair with acromioplasty

Procedure: Tendon repair with acromioplasty

Physiotherapy

ACTIVE COMPARATOR

Physiotherapy by exercises

Procedure: Physiotherapy

Interventions

Tendon repair with acromioplastyPROCEDURE

Open or mini-open tendon repair in combination with an acromioplasty and eventually a tenodesis of the long head of the biceps

Surgical treatment
PhysiotherapyPROCEDURE

According to a rehabilitation program which was established prior to study start.

Physiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical history and imaging findings of a rotator cuff tear

You may not qualify if:

  • Presence of other local or systemic diseases influencing on shoulder function
  • History of earlier rotator cuff surgery
  • Medical contraindications for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martina Hansen's Hospital

Sandvika, 1306, Norway

Location

Related Publications (3)

  • 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: 20044684RESULT

  • 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: 25232074RESULT

  • Moosmayer S, Lund G, Seljom US, Haldorsen B, Svege IC, Hennig T, Pripp AH, Smith HJ. At a 10-Year Follow-up, Tendon Repair Is Superior to Physiotherapy in the Treatment of Small and Medium-Sized Rotator Cuff Tears. J Bone Joint Surg Am. 2019 Jun 19;101(12):1050-1060. doi: 10.2106/JBJS.18.01373.

    PMID: 31220021RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Stefan Moosmayer, MD

    Vestre Viken Hospital Trust

    PRINCIPAL INVESTIGATOR

  • Hans-Joergen Smith, MD, PhD

    University of Oslo, Rikshospitalet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 26, 2009

First Posted

February 27, 2009

Study Start

September 1, 2004

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

March 15, 2023

Record last verified: 2023-03

Locations

NO(1)