NCT02943005

Brief Summary

The aim of this study is to compare rehabilitation with the wearing of a sling, to rehabilitation without any immobilization after an arthroscopic repair of the supraspinatus tendon. The goal is to offer to patients a simplified rehabilitation management, with a faster recovery, less pain and a quicker return to normal life.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

October 9, 2016

Last Update Submit

December 15, 2016

Conditions

Rotator Cuff

Outcome Measures

Primary Outcomes (1)

  • ASES score

    Clinical score (0-100)

    3 months

Secondary Outcomes (1)

  • Retear or non healing of the rotator cuff

    6 months

Other Outcomes (9)

  • Return to sports

    6 months

  • Work absenteeism

    6 months

  • Complications (i.e frozen shoulder)

    6 months

  • +6 more other outcomes

Study Arms (2)

Rotator cuff repair with sling

ACTIVE COMPARATOR

Patients wear a sling during 4 weeks, they also move passively during this period. Then progressive active mobilization is done.

Procedure: Rotator cuff repair

Rotator cuff repair without sling

EXPERIMENTAL

Patients don't wear any sling, they move passively in all axes during 4 weeks. Then progressive active mobilization is done.

Procedure: Rotator cuff repair

Interventions

Rotator cuff repairPROCEDURE
Rotator cuff repair with slingRotator cuff repair without sling

Eligibility Criteria

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

You may qualify if:

  • Patients over 18 years old
  • Small tear (\< 3cm) of the supraspinatus tendon
  • Arthroscopic cuff repair

You may not qualify if:

  • Lesion of the anterior or posterior rotator cuff
  • Significant other trauma of the involved upper member (e.g. associated scapular or clavicular fractures, acromioclavicular dislocation)
  • Preoperative shoulder stiffness
  • Inability to follow properly post-surgery recommendations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Tour Hospital

Meyrin, Canton of Geneva, 1217, Switzerland

RECRUITING

Study Officials

  • Alexandre Lädermann, MD

    La Tour Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Lädermann, MD

CONTACT

227197555alexandre.laedermann@gmail.com

Adrien Switzguebel, MD

CONTACT

227197555adrien.schwitzguebel@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

October 9, 2016

First Posted

October 24, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2019

Last Updated

December 16, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)