Post-operative Mobilisation After Rotator Cuff Repair

Rotator Cuff Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02943005
• Other study ID #: 2016-00818
• Status: Recruiting
• Phase: N/A
• First received: October 9, 2016
• Last updated: December 15, 2016
• Start date: September 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2016
• Source: La Tour Hospital
• Contact: Alexandre Lädermann, MD
• Phone: 227197555
• Email: alexandre.laedermann[@]gmail.com
• Is FDA regulated: No
• Health authority: Switzerland: Swissethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff

Intervention

Procedure:
• Rotator cuff repair

Locations

Country	Name	City	State
Switzerland	La Tour Hospital	Meyrin	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
La Tour Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Return to sports	Yes/no	6 months	No
Other	Work absenteeism	Months	6 months	No
Other	Complications (i.e frozen shoulder)	Description of complication	6 months	No
Other	Number of physiotherapy sessions needed.	Clinical evolution	6 months	No
Other	VAS score	Graded between 0 and 10	1.5, 3, and 6 months	No
Other	Constant score	Clinical scores number between 0-100	1.5, 3, and 6 months	No
Other	SANE score	Clinical scores number between 0-10	1.5, 3, and 6 months	No
Other	ASES score	Clinical scores number between 0-100	1.5, 3, and 6 months	No
Other	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	No
Primary	ASES score	Clinical score (0-100)	3 months	No
Secondary	Retear or non healing of the rotator cuff	Ultrasound control	6 months	No