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

• Status: Completed
• Conditions: Rhizarthrosis
• Intervention / Treatment: Device: Regjoint

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1040
    • Clinique du Parc Leopold
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brugmann University Hospital
• Investigators: Principal Investigator: Morgan Gason, MD, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): October 10, 2018
• Study Completion (Actual): October 10, 2018

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Rhizarthrosis; Regjoint; Trapeziectomy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CHUB-Regjoint_TMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No