Arthropathy of Hand
Conditions
Brief summary
Rhizarthrosis is a frequently occurring pathology leading to severe limitations in daily life due to pain and loss of function. Good clinical results have been reported for some carpometacarpal (CMC) joint prosthesis designs, but high failure rates due to loosening and dislocation must be considered. The study aim was to investigate a new, double mobility CMC-prosthesis design with special focus on (1) the functional outcome and (2) patient quality of life (QOL)
Detailed description
The Epping resection-suspension arthroplasty procedure was described in 1983 to address the proximal migration of the first ray while providing pain free grip strength without any implants. It has shown rather good functional outcome and pain relief. A reduction in thumb opposition strength of 27% compared to the contralateral side and intermittent pain in physical activity is reported, however. Further, studies comparing trapeziectomy and trapeziectomy with tendon interposition recommend trapeziectomy due to the simple technique and comparable outcome. Endoprosthesis of the first carpometacarpal (CMC) joint represents a different treatment strategy aiming at an exact reconstruction of the joint geometry. Some studies report excellent functional outcome and pain relief. However, there are some prosthesis designs (cemented and uncemented) with high rates of loosening, luxation and poor subjective results. To address these issues, a prosthesis was designed combining a cylindric, double mobility cup and a hydroxyapatite covered stem and cup available in different sizes. The aim of this study was to compare this new prosthesis design to the Epping arthroplasty as the current standard in the investigator's institution regarding (1) the functional outcome with special focus on mobility and strength and (2) patient quality of life (QOL) and pain relief. Note: The registration of this trial on Clinicaltrials.gov was carried out retrospectively after primary completion of the study.
Interventions
PROCEDUREEpping resection arthroplasty
Follwing the described epping resection arthroplasty, The first ray was immobilized using an orthosis for four weeks postoperatively in both study groups followed by eight weeks of physical therapy.
PROCEDURECMC I prosthesis
Follwing the described CMC I prosthesis procedure, The first ray was immobilized using an orthosis for four weeks postoperatively in both study groups followed by eight weeks of physical therapy.
Sponsors
Stryker Instruments
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Patients are radomized into two groups prior to the surgical intervention using the radomizing programm of the medical university of graz.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* symptomatic rhizarthrosis grade 2 and 3 according to Eaton's classification, * failed conservative treatment prior to surgery, * written informed consent to the study.
Exclusion criteria
* scaphotrapezotrapezoidal (STT) arthrosis, * former CMC joint surgery, * patients under custodianship.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome- Thumb opposition | twelve months postoperative | Measurement of thumb opposition (scale from 1 to 10) range according to Kapandji. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition. |
| Functional outcome - Thumb retropulsion | twelve months postoperative | Measurement of thumb retropulsion (scale from 1 to 3) range according to Kapandji |
| Functional outcome - maximal palmar abduction | twelve months postoperative | measurement of the maximal palmar abduction using a goniometer. |
| Functional outcome - maximal radial abduction | twelve months postoperative | measurement of the maximal radial abduction using a goniometer. |
| Functional outcome - tip-to-tip force | twelve months postoperative | The tip-to-tip force (between thumb and index finger) was measured in Newton (N) using a handheld dynamometer (Cit Technics, Haren, Netherlands). |
Outcome results
None listed