NCT02059473

Brief Summary

The purpose of this project is to compare operative repair of traumatically torn rotator cuff tendon with physiotherapy in a randomized prospective study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

2.1 years

First QC Date

February 4, 2014

Last Update Submit

February 7, 2014

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

  • Constant-Murley Shoulder Assessment score

    Twelve months

Secondary Outcomes (2)

  • Western Ontario Rotator Cuff score

    Twelve months

  • MRI

    Twelve months

Other Outcomes (2)

  • Euro-Qol-five-Dimensions (EQ-5D)

    Twelve months

  • Patient Global Impression of Change (PGIC)

    Twelve months

Study Arms (2)

Physiotherapy & Surgery

EXPERIMENTAL

Mini-open rotator cuff repair

Procedure: Rotator cuff repairProcedure: Physiotherapy

Physiotherapy

ACTIVE COMPARATOR

Structured physiotherapy

Procedure: Physiotherapy

Interventions

Rotator cuff repairPROCEDURE

Physiotherapy \& Surgery

Physiotherapy & Surgery
PhysiotherapyPROCEDURE
PhysiotherapyPhysiotherapy & Surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Trauma to the shoulder
  • Full thickness cranial rotator cuff tear
  • Operation possible within 3 months

You may not qualify if:

  • or more rotator cuff tendons involved
  • Fracture
  • Dislocation
  • Previous shoulder condition (symptomatic osteoarthritis (Gleno-humeral (GH) joint, Acromial-Clavicular (AC) joint), frozen shoulder, instability, tumor)
  • Malignancy
  • Rheumatic disease
  • Inability to understand swedish
  • Substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedic Clinic, Linköping University Hospital

Linköping, 58185, Sweden

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Lars Adolfsson, Professor

    Linkoeping University

    PRINCIPAL INVESTIGATOR

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
PHD, Orthopeadic shouldersurgeon

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 11, 2014

Study Start

November 1, 2013

Primary Completion

December 1, 2015

Study Completion

November 1, 2017

Last Updated

February 11, 2014

Record last verified: 2014-02

Locations

SE(1)