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OpenTrials
Completed

NCT Number: NCT02261701

Rehabilitation After Rotator Cuff Repair

A new postoperative regimen with a new bandage technique after surgery results in a better shoulder function and quality of life after surgery - than traditional postoperative regimen with shoulder lock and abductor cushion.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopaedic surgery, Physiotherapy

Västerås, Västmanland County, 721 89, Sweden

About this study

A new postoperative regimen , with a new bandage technique with shorter immobilization time and without shoulder lock, is supposed to results in a better shoulder function 6 and 12 months after surgery. Function is measured by Constant score, pain with VAS and quality of life with EQ5D, 3 and 12 months after surgery. The two treatment groups are compared.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • planned shoulder surgery, rotator cuff repair

Exclusion criteria

  • not swedish speaking
  • reoperation

Treatment and study plan

Early mobilization

Other

Early mobilization, collar´n cuff 4 weeks post surgery and after this light exercises start and no further bandage.

Other names: Collar´n cuff 4 weeks post surgery and early mobilization

Post surgery shoulder lock

Other

Post surgery: Shoulder lock with abduction cushion, additionally 3 weeks with collar´n cuff, and after this period light exercises are allowed and nu further bandage.

Other names: Shoulder lock three weeks post surgery

Primary outcomes

  1. Shoulder function

    Time frame: 6 months after surgery

    Shoulder function is assessed by Constant score

Secondary outcomes

  1. Pain

    Time frame: 6 months after surgery

    Visual analogue scale

Other outcomes

  1. EQ-5D

    Time frame: 6 months after surgery

    Quality of life

  2. Quality of life shoulder specific

    Time frame: 6 months after surgery

    Western Ontario Rotator Cuff Index (WORC)

  3. Pain

    Time frame: 12 months after surgery

    Visual analogue scale

  4. Euro quality of Life 5D

    Time frame: 12 months after surgery

    Quality of life

  5. Quality of life shoulder specific

    Time frame: 12 months after surgery

    Western Ontario Rotator Cuff Index (WORC)

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

Rehabilitation After Rotator Cuff Repair a Randomised Controlled Study

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 10, 2014
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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