- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03320291
Long-term Evaluation of Primary Trapeziectomy and Placement of a RegJoint Implant in the Treatment of Rhizarthrosis
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).
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brussel, Belgium, 1040
- Clinique du Parc Leopold
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Brussels, Belgium, 1020
- CHU Brugmann
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Regjoint
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Implant of poly-L / D-lactide (Regjoints®) in the treatment of trapezo-metacarpal osteoarthritis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain visual assessment scale (EVA scale)
Time Frame: 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).
|
1 year post surgery
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Quick-DASH questionnaire
Time Frame: 1 year post surgery
|
Evaluation of the return to daily life activities (work and sport)
|
1 year post surgery
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Prehension force
Time Frame: 1 year post surgery
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Measured with a Standard Dynamometer or Hydraulic Pinch Gauge, with the contralateral hand used for comparison.
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1 year post surgery
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Maximal amplitude of the articulation
Time Frame: 1 year post surgery
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Measurement of the angle between the axis of the thumb and the index finger, palmar, with a goniometer
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1 year post surgery
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Maximal amplitude of the articulation
Time Frame: 1 year post surgery
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Measurement of the angle between the axis of the thumb and the index finger, radial, with a goniometer
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1 year post surgery
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Eroded depth
Time Frame: 1 year post surgery
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Evaluation of the bone erosion by means of a radiography (face/profile/oblique).
Measure of the degree of subluxation/dislocation.
|
1 year post surgery
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Kapandji score
Time Frame: 1 year post surgery
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Evaluation of the mobility of the thumb carpal-metacarpal joint
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1 year post surgery
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metacarpus length
Time Frame: 1 year post surgery
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Computed by radiography
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1 year post surgery
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metacarpal space length
Time Frame: 1 year post surgery
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Computed by radiography
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1 year post surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Morgan Gason, MD, CHU Brugmann
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUB-Regjoint_TMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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