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ID
Source
Brief title
Health condition
Total elbow arthroplasty for all indications.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Fixed Flexion Deformity
Secondary outcome
Pain, function of the elbow, stability, quality of life, positioning of the prosthesis.
Background summary
Total elbow arthroplasty (TEA) is increasingly used to treat a variety of debilitating elbow pathologies. The number of TEAs performed in the Netherlands has grown over the last couple of years, but unfortunately the reported complication rates remain high. New surgical approaches have been developed to lower complication rates. There are several surgical options including the triceps-splitting approach and the upcoming triceps-sparing approach, but it is not clear which would yield better outcomes. Both approaches have their advantages and disadvantages. The main advantage of a triceps splitting approach is the great exposure, while a triceps-sparing approach offers the possibility of direct functional treatment. We want to investigate the functional and radiological outcomes and complication rates after the triceps splitting and triceps-sparing approaches in TEA.
The aim of this study is to investigate the functional and radiological outcomes and complication rates after the triceps-sparing and triceps splitting approaches in TEA.
This study will be conducted as a prospective cohort study comparing the triceps-sparing technique to triceps splitting technique. All patients >18 years old with an indication for a primary elbow prosthesis will be included.
Study objective
The null hypothesis is that there is no statistical difference between outcomes and complication rates of the two groups.
Study design
pre-operative, 6 months post-operative, 12 months post-operative
Inclusion criteria
Age ≥ 18 years old with an indication for a primary total elbow prosthesis
Ability to participate during the entire follow up schedule
Exclusion criteria
Total elbow prosthesis surgery in the past (at the ipsilateral side)
Previous elbow surgery that influences the function of the triceps muscle
Other upper extremity injuries to the ipsilateral limb that would compromise postoperative rehabilitation
Inability to follow post-rehabilitation (due to head injury, dementia, mental illness etc.)
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 | NL8488 |
| Other | METc UMCG : METc 2019/544 |