NCT02261701

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration 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, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

2.9 years

First QC Date

September 3, 2014

Last Update Submit

May 3, 2018

Conditions

Rotator Cuff Injury

Keywords

shoulder surgeryrotator cuff injuryrehabilitationfunctionpainquality of life

Outcome Measures

Primary Outcomes (1)

  • Shoulder function

    Shoulder function is assessed by Constant score

    6 months after surgery

Secondary Outcomes (1)

  • Pain

    6 months after surgery

Other Outcomes (5)

  • EQ-5D

    6 months after surgery

  • Quality of life shoulder specific

    6 months after surgery

  • Pain

    12 months after surgery

  • +2 more other outcomes

Study Arms (2)

Early mobilization

EXPERIMENTAL

Intervention is early mobilization, four weeks immobilization postsurgery with collar´n cuff only.

Other: Early mobilization

Post surgery shoulder lock

OTHER

Post surgery shoulder lock with abduction cushion 3 weeks and after this period collar´n cuff 3 weeks

Other: Post surgery shoulder lock

Interventions

Early mobilizationOTHER

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

Also known as: Collar´n cuff 4 weeks post surgery and early mobilization
Early mobilization
Post surgery shoulder lockOTHER

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.

Also known as: Shoulder lock three weeks post surgery
Post surgery shoulder lock

Eligibility Criteria

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

You may qualify if:

  • planned shoulder surgery, rotator cuff repair

You may not qualify if:

  • not swedish speaking
  • reoperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedic surgery, Physiotherapy

Västerås, Västmanland County, 721 89, Sweden

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesPain

Interventions

Early AmbulationPostoperative Period

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPerioperative PeriodSurgical Procedures, OperativeHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ann Christin Johansson, PhD

    Center for Clinical Research County Västmanland, Sweden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2014

First Posted

October 10, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2017

Study Completion

October 30, 2017

Last Updated

May 9, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)