Supraspinatus Injury
Conditions
Brief summary
The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling). Both groups will be also treated according to standard of care with physiotherapy and progressive introduction of movements.
Detailed description
The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling). Both groups will then perform only passive movements according to pain for the first 6 weeks supported by the physiotherapy, according to standard therapy. The following six weeks passive movements will be associated with active movements . No brace nor normal sling will be used anymore. Patients are in study for 6 months. During this period quality of life and pain questionnaires are submitted to the patients and a MRI will be done at the end of the study.
Interventions
PROCEDUREBrace
A brace to be weared according to protocol
PROCEDURENormal sling
A normal sling to be weared according to protocol
Sponsors
Clinical Trial Unit Ente Ospedaliero Cantonale
Christian Candrian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized 1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* Males or females between 18 and 65 years old; * Presence of an isolated lesion of supraspinatus that can be documented with the MRI and which can be treated surgically by arthroscopy; * Presence of a supraspinatus lesion according to the Patte criteria with stage 1, 2 or 3 frontal plane ; * Presence of adipose degeneration ≤ 2 according to Goutallier; * Written informed consent to participate in the study
Exclusion criteria
* Presence of a lesion of other rotator cuff tendons; * Previous surgical procedures of the shoulder; * Presence of a massive lesion, therefore irreparable, of the cuff detected intra-operatively and not observed during preoperative MRI; * Presence of relapsing shoulder dislocations; * Presence of lesions of the glenoidine cercine that require intervention; * Difficulties to follow the rehabilitation programs; * Presence of neoplastic diseases, metabolic diseases, inflammatory and systemic diseases, autoimmune diseases and immunosuppressed patients; * State of pregnancy (presumed or established) or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy in the rehabilitative therapy | 6 months | The primary objective of the study is to evaluate two different rehabilitative therapies. Efficacy is measured with a pre and post MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessment | 6 months | Evaluation of the quality of live in both groups through Constant Quality of Life questionnair up to 6 months |
| re-rupture rate of the supraspinatus tendon | 6 months | Evaluation of the re-rupture of the supraspinatus tendon though a follow up MRI at 6 months |
Countries
Switzerland
Outcome results
None listed