M19.92
Conditions
Interventions
Group 1: Shoulder TEP patients with refixation of the subscapularis
Group 2: Shoulder TEP patients without refixation of the subscapularis
Sponsors
Waldkliniken Eisenberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients with osteoarthritis of the shoulder or rotator cuff deficient arthropathy who receive an inverse shoulder TEP. - Willingness to participate in the study and signing of the informed consent form.
Exclusion criteria
Exclusion criteria: - Patients with relevant pre-existing conditions that could affect the outcome of the operation (e.g. advanced neurological diseases, rheumatoid arthritis, post-traumatic arthrosis) - Previous operations that significantly impair shoulder function. - Lack of willingness to participate or lack of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of the modified Constant Score postoperatively The only planned change from the previous standardised measures for an inverse shoulder TEP is the collection of a modified Constant score with extended strength measurement and length measurement. The postoperative follow-up checks, including radiological follow-up checks, are carried out according to the in-house standard and will not be changed for the study. The data collection includes clinical examinations, the modified Constant Score including strength and length measurements as well as pre- and post-operative radiological checks. The results will then be analysed to investigate the influence of subscapularis tendon refixation on the clinical and functional outcome. Data collected during routine clinical practice will be analysed for the study at a minimum of 4 time points. Preoperative - Gender, age, height, weight, surgical site, secondary diagnoses, medication - Clinical scores (modified Constant Score) - X-ray (shoulder in 2 planes, CT if necessary) Postoperative - Occurrence of any complications - Clinical scores (modified Constant Score) - X-ray (shoulder in 2 planes, CT if necessary) - Time points: - After 12 weeks - After 6 months - After 1 year - After 2 years if necessary - After 5 years, if applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| • Difference in force measurements between the groups with and without subscapularis refixation • Radiological findings regarding implant position and any complications • Patient satisfaction and subjective pain perception • Functional outcomes based on specific ranges of motion • Occurrence of complications | — |
Countries
Germany
Contacts
Public ContactStefan Pietsch
Waldkliniken Eisenberg
Outcome results
None listed