rotator cuff tear shoulder tendon tear
Conditions
Interventions
Patients are randomized into two groups: all patients are treated for
supraspinatus/infraspinatus tendon lesion using a standardized arthroscopic
rotator cuff repair
Group one (control group) will receive standard
postoperative immobilization (e.g. a sling for a period of 6 weeks) and group
two (BTA group) consists of patients in which the supra/infraspinatus mu
Sponsors
HagaZiekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - willing and able to participate in the study protocol - age * 18 years - symptomatic tear of the supraspinatus tendon, not responding to conservative treatment. - male and female patients
Exclusion criteria
Exclusion criteria: - hypersensitivity to Botox - neuromuscular diseases - diabetes - pregnant or nursing - aged under eighteen - a language barrier - mental disabilities - additional injury as in fractures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether postoperative immobilization of the rotator cuff, after arthroscopic rotator cuff repair using botulinum toxin, leads to improved postoperative pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine whether postoperative immobilization of the rotator cuff, after arthroscopic rotator cuff repair using botulinum toxin, leads to no more surgical failures than using traditional six-week sling immobilization. Endpoint: re-tears in the supra/ infraspinatus tendon (ultra sound, mri).To determine whether postoperative immobilization of the rotator cuff, after arthroscopic rotator cuff repair using botulinum toxin, leads to improved functional outcome and strength. To determine the difference in electrical muscle activity (EMG) and if the surgery leads to a spontaneous reversible neuropraxia. | — |
Countries
Netherlands
Outcome results
None listed