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ID
Source
Brief title
Health condition
shoulder complaints based on omarthrosis, rotator cuff arthropathy, avascular necrosis and (late) post traumatic
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the difference in Oxford Shoulder Score (OSS) from preoperative to 6 weeks postoperative.
Secondary outcome
Secondary study parameters are:
1. Difference in (ROM), VAS pain scores in rest and during activity and the quality of life (EQ-5D) from preoperative to 6 weeks postoperative.
2. Difference in OSS, (ROM), VAS pain scores in rest and during activity and the quality of life (EQ-5D) from preoperative to 3 months postoperative
3. Difference in OSS, (ROM), VAS pain scores in rest and during activity and the quality of life (EQ-5D) from preoperative to 1 year postoperative
4. Complications and re-admissions until 1 year postoperative.
5. Society costs including healthcare costs, patient and family costs and lost productivity costs.
Background summary
In the Dijklander hospital and St Anna hospital, the technique without reattachement of the subscapularis tendon during surgery for a reversed shoulder prosthesis (rTSA) has been used for the last few years with excellent results. The rTSA being used has been designed to increase stability. Without the need to reattach the subscapularis tendon and the stability provided by the rTSA patients mobilization can start directly postoperative, providing improved range of motion (ROM) and an increased independent daily life. When patients start mobilization immediately post-operative and immobilization will not be necessary, we expect them to be less dependent on care of a district nurse or family members. Also a faster recovery is expected with an increased shoulder function and self-reported functional outcome on short term.
Study objective
When patients start mobilization immediately post-operative and immobilization will not be necessary, we expect them to be less dependent on care of a district nurse or family members. Also a faster recovery is expected with an increased shoulder function and self-reported functional outcome on short term.
Study design
Preoperative, and 6 weeks, 3 months and 1 year postoperative
Intervention
not applicable
Inclusion criteria
• 50 years and older
• Selected for rTSA surgery
• Complete understandig of the study and signed informed consent
Exclusion criteria
• Selected for rTSA with the indication of fracture treatment after an acute trauma
• Individuals who are unable to follow an intense mobilization program.
• Individuals who are unable to complete the PROMs questionnaires.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7656 |
| Other | METC VUmc : METC VUmc 2019.111 |