An interventional study of Regjoint in Rhizarthrosis, sponsored by Brugmann University Hospital. Completed at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-17.
Sponsored by Brugmann University Hospital · Not applicable, Interventional, and Treatment
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).
Exclusion Criteria:
Device: Regjoint
Implant of poly-L / D-lactide (Regjoints®) in the treatment of trapezo-metacarpal osteoarthritis
Pain visual assessment scale (EVA scale)
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).
Time frame: 1 year post surgery
Quick-DASH questionnaire
Evaluation of the return to daily life activities (work and sport)
Time frame: 1 year post surgery
Prehension force
Measured with a Standard Dynamometer or Hydraulic Pinch Gauge, with the contralateral hand used for comparison.
Time frame: 1 year post surgery
Maximal amplitude of the articulation
Measurement of the angle between the axis of the thumb and the index finger, palmar, with a goniometer
Time frame: 1 year post surgery
Maximal amplitude of the articulation
Measurement of the angle between the axis of the thumb and the index finger, radial, with a goniometer
Time frame: 1 year post surgery
Eroded depth
Evaluation of the bone erosion by means of a radiography (face/profile/oblique). Measure of the degree of subluxation/dislocation.
Time frame: 1 year post surgery
Kapandji score
Evaluation of the mobility of the thumb carpal-metacarpal joint
Time frame: 1 year post surgery
metacarpus length
Computed by radiography
Time frame: 1 year post surgery
metacarpal space length
Computed by radiography
Time frame: 1 year post surgery
Plan to share: No
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Brugmann University Hospital