Rhizarthrosis
Conditions
Keywords
Rhizarthrosis, Regjoint, Trapeziectomy
Brief summary
In a society based on the use of everyday tools and objects, the loss of function of one or both thumbs due to Rhizarthrosis can drastically reduce the quality of life. Many patients are refractory to preservative treatments.Therefore, multiple arthroplasty techniques were developed. Trapeziectomy, with or without tendon interposition, gives very good results in terms of pain, function or force. However, it can result in a reduction of the size of the column of the thumb, therefore leading to a loss of force. Replacement of the trapezo-metacarpal joint with prosthetic material is also proposed and has the advantage to avoid the reduction of the thumb column. Several models are available, mono or bipolar, with a conical or hemispherical cup. Another option is the placement of implants. They were first used when a partial trapeziectomy was possible to counter the collapse of the column and are made of different materials such as metal, silicone, ceramic, pyrocarbon , and gelfoam. The bioabsorbable poly-LD-lactide implant (PLDLA) is a relatively new possibility for the reconstruction of small joints. Studies have previously revealed that the PLDLA implant is biocompatible and represents a good alternative to arthroplasty by tendon interposition in the reconstruction of the trapezo-metacarpal articulation with osteoarthritis. In this study, the investigators will investigate the long term effects (1 year after placement) of the Regjoint, a poly-LD-lactide implant (PLDLA).
Interventions
DEVICERegjoint
Implant of poly-L / D-lactide (Regjoints®) in the treatment of trapezo-metacarpal osteoarthritis
Sponsors
Brugmann University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults\> 18 years * Patients having had a trapeziectomy for more than one year, because of chronic Rhizarthrosis defined by pain and Radiographic Signs, aka articular pinching, bone erosion and potential subluxation of the trapezo-metacarpal joint.
Exclusion criteria
* Surgery less than 1 year ago. * Concomitant pathology of the thumb or wrist (Recent injury or trauma, Quervain tenosynovitis, Carpal tunnel syndrome, Dupuytren, jumping finger). * Trapeziectomy secondary to distal prosthesis and scaphoidectomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain visual assessment scale (EVA scale) | 1 year post surgery | Pain evaluation in the thumb column by means of the EVA scale. The EVA scale consists of a 10cm graduated strip. The patient must point its pain level on the strip: 0 cm means 'no pain' (one end of the strip) and 10 cm means 'unbearable pain' (other end of the strip). |
| Quick-DASH questionnaire | 1 year post surgery | Evaluation of the return to daily life activities (work and sport) |
| Prehension force | 1 year post surgery | Measured with a Standard Dynamometer or Hydraulic Pinch Gauge, with the contralateral hand used for comparison. |
| Maximal amplitude of the articulation | 1 year post surgery | Measurement of the angle between the axis of the thumb and the index finger, palmar, with a goniometer |
| Eroded depth | 1 year post surgery | Evaluation of the bone erosion by means of a radiography (face/profile/oblique). Measure of the degree of subluxation/dislocation. |
| Kapandji score | 1 year post surgery | Evaluation of the mobility of the thumb carpal-metacarpal joint |
| metacarpus length | 1 year post surgery | Computed by radiography |
| metacarpal space length | 1 year post surgery | Computed by radiography |
Countries
Belgium
Outcome results
None listed