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

NCT03320291 | Completed

• 1 other identifier: CHUB-Regjoint_TMC
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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).

Conditions

Rhizarthrosis

Keywords

Rhizarthrosis; Regjoint; Trapeziectomy

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

Regjoint

EXPERIMENTAL

Device: Regjoint

Interventions

Regjoint DEVICE

Implant of poly-L / D-lactide (Regjoints®) in the treatment of trapezo-metacarpal osteoarthritis

Regjoint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (2)

CHU Brugmann

Brussels, 1020, Belgium

Location

Clinique du Parc Léopold

Brussels, 1040, Belgium

Location

Study Officials

• Morgan Gason, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 25, 2017
• Study Start: November 1, 2017
• Primary Completion: October 10, 2018
• Study Completion: October 10, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)