Long-term Evaluation of Primary Trapeziectomy and Placement of a RegJoint Implant in the Treatment of Rhizarthrosis

Study Overview
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Brief Summary
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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).

Official Title
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Long-term Evaluation of Primary Trapeziectomy and Placement of a RegJoint Implant in the Treatment of Rhizarthrosis

Conditions
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Rhizarthrosis

Intervention / Treatment
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* Device: Regjoint


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regjoint<br> | Device: Regjoint<br>* Implant of poly-L / D-lactide (Regjoints®) in the treatment of trapezo-metacarpal osteoarthritis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 year post surgery | 
| Quick-DASH questionnaire | Evaluation of the return to daily life activities (work and sport) | 1 year post surgery | 
| Prehension force | Measured with a Standard Dynamometer or Hydraulic Pinch Gauge, with the contralateral hand used for comparison. | 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 | 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 | 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. | 1 year post surgery | 
| Kapandji score | Evaluation of the mobility of the thumb carpal-metacarpal joint | 1 year post surgery | 
| metacarpus length | Computed by radiography | 1 year post surgery | 
| metacarpal space length | Computed by radiography | 1 year post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhizarthrosis, Regjoint, Trapeziectomy