Osteoarthritis
Conditions
Brief summary
The primary objective is to investigate the active extension six months after implantation of the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach. This is a randomized controlled trial including 70 patients with PIP OA indicated for CapFlex arthroplasty.
Detailed description
The CapFlex-PIP© implant is a modular gliding surface proximal interphalangeal (PIP) joint prosthesis. For implantation, there are two approaches available: The dorsal central split approach according to Swanson and the volar approach described by Simmen. Our experiences and data from our prospective registry indicate, that the active extension of the PIP joint is better after the dorsal approach, but sometimes related with hyperextension of the PIP joint and secondary swan-neck deformity. Extension is supposed to be better after the volar approach, but associated with active and passive extension lag. Evidence of theses experiences will assist the surgeon in the preoperative planning to select the appropriate approach according to the patient's needs. The primary objective is to investigate the active extension six months after implantation of the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach. This is a randomized controlled trial.
Interventions
PROCEDUREDorsal approach CapFlex arthroplasty
Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the dorsal approach.
PROCEDUREVolar approach CapFlex arthroplasty
Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the volar approach.
Sponsors
Miriam Marks
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication for CapFlex-PIP© arthroplasty * Patient aged 18 years and over * Informed Consent as documented by signature
Exclusion criteria
* Revision surgery * CapFlex-PIP© arthroplasty at the thumb IP joint * Major surgery at the same finger (e.g. DIP arthrodesis) * Ulnar/radial deviation of the PIP joint \> 15° * Patients in which a reconstruction of the collateral ligaments has to be performed * General medical contraindication to surgery * German language barrier to complete the questionnaires * Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder) * Pregnancy * Surgery not planned by Dr. Herren, Dr. Schindele or Dr. Bodmer * Legal incompetence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Active extension of the PIP joint measured with a goniometer | 6 months after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Subjective function using the Brief Michigan Hand Questionnaire (briefMHQ) | 6 months after surgery |
Countries
Switzerland
Outcome results
None listed