Post-operative Mobilisation After Rotator Cuff Repair

Post-operative Mobilisation After Rotator Cuff Repair: Sling Versus Nothing. A Randomized Prospective Study.

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.

Study Overview

• Status: Unknown
• Conditions: Rotator Cuff
• Intervention / Treatment: Procedure: Rotator cuff repair

Detailed Description

Rotator cuff tear is a frequent problem, increasing with age1. Thus arthroscopic repair is a frequent surgery. Despite this important number of cuff repair, the re-tear rate varies from 20 to 90% depending on tear severity and type of repair1,2. Many factors are implicated in tendon healing and post-operative clinical results. Some are unchangeable (age, tear size, chronicity…) but some are under the surgeon control like the surgical technique and the post-operative rehabilitation protocol. It exists many surgical repair techniques6, 7, with a massive development of technology during the last twenty years. However in terms of rehabilitation, there is only few studies and evidence of best practices4. The main aspect on which the surgeon can act, is the immobilization time. Actually, standard protocols include an immobilisation of 4 to 6 weeks before physiotherapy beginning5.

A recent review of the literature3 has highlighted five studies comparing different rehabilitation protocols, which include different immobilization periods ranging from 0 to 8 weeks, and different types of mobilization (under physiotherapist supervision or not, with machine or not). They found a similar rate of re-tear between the different protocols. But early passive motion enables to improve the range of motion during first 3-6 months, with similar results at one year.

However in all these studies, all patients had to wear a sling for at least 4 weeks, even in the early mobilization group. But the investigators don't know if this sling is really useful, probably not if the investigators follow the logic of faster recovery and same long term results with early mobilization. At our best knowledge, no study has sought to compare the usefulness of sling wearing after a rotator cuff repair. Removing sling could simplify rehabilitation and should provide a return to normal function faster, with greater satisfaction and a similar rate of re-tear.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandre Lädermann, MD; Phone Number: 0041 227197555; Email: alexandre.laedermann@gmail.com
• Study Contact Backup: Name: Adrien Switzguebel, MD; Phone Number: 0041 227197555; Email: adrien.schwitzguebel@gmail.com

Study Locations

• Switzerland
  • Geneva
    • Meyrin, Geneva, Switzerland, 1217
      • Recruiting
      • La Tour Hospital
      • Contact: Alexandre Lädermann, MD; Phone Number: +41227197555; Email: alexandre.laedermann@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rotator cuff repair with sling; Patients wear a sling during 4 weeks, they also move passively during this period. Then progressive active mobilization is done.	Procedure: Rotator cuff repair
Experimental: Rotator cuff repair without sling; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASES score	Clinical score (0-100)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retear or non healing of the rotator cuff	Ultrasound control	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to sports	Yes/no	6 months
Work absenteeism	Months	6 months
Complications (i.e frozen shoulder)	Description of complication	6 months
Number of physiotherapy sessions needed.	Clinical evolution	6 months
VAS score	Graded between 0 and 10	1.5, 3, and 6 months
Constant score	Clinical scores number between 0-100	1.5, 3, and 6 months
SANE score	Clinical scores number between 0-10	1.5, 3, and 6 months
ASES score	Clinical scores number between 0-100	1.5, 3, and 6 months
Strength of arms in Jobe position	Strength measurement in kilo according to the technique of Int Shoulder Surg Collin et al. In press	6 months

Collaborators and Investigators

• Sponsor: La Tour Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 9, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Estimate): December 16, 2016
• Last Update Submitted That Met QC Criteria: December 15, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2016-00818

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No