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

Primary Purpose

Rhizarthrosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Regjoint
Sponsored by
Brugmann University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhizarthrosis focused on measuring Rhizarthrosis, Regjoint, Trapeziectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Brugmann
  • Clinique du Parc Léopold

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Regjoint

Arm Description

Outcomes

Primary Outcome Measures

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).
Quick-DASH questionnaire
Evaluation of the return to daily life activities (work and sport)
Prehension force
Measured with a Standard Dynamometer or Hydraulic Pinch Gauge, with the contralateral hand used for comparison.
Maximal amplitude of the articulation
Measurement of the angle between the axis of the thumb and the index finger, palmar, with a goniometer
Maximal amplitude of the articulation
Measurement of the angle between the axis of the thumb and the index finger, radial, with a goniometer
Eroded depth
Evaluation of the bone erosion by means of a radiography (face/profile/oblique). Measure of the degree of subluxation/dislocation.
Kapandji score
Evaluation of the mobility of the thumb carpal-metacarpal joint
metacarpus length
Computed by radiography
metacarpal space length
Computed by radiography

Secondary Outcome Measures

Full Information

First Posted
October 10, 2017
Last Updated
April 16, 2019
Sponsor
Brugmann University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03320291
Brief Title
Long-term Evaluation of Primary Trapeziectomy and Placement of a RegJoint Implant in the Treatment of Rhizarthrosis
Official Title
Long-term Evaluation of Primary Trapeziectomy and Placement of a RegJoint Implant in the Treatment of Rhizarthrosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
October 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhizarthrosis
Keywords
Rhizarthrosis, Regjoint, Trapeziectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regjoint
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Regjoint
Intervention Description
Implant of poly-L / D-lactide (Regjoints®) in the treatment of trapezo-metacarpal osteoarthritis
Primary Outcome Measure Information:
Title
Pain visual assessment scale (EVA scale)
Description
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
Title
Quick-DASH questionnaire
Description
Evaluation of the return to daily life activities (work and sport)
Time Frame
1 year post surgery
Title
Prehension force
Description
Measured with a Standard Dynamometer or Hydraulic Pinch Gauge, with the contralateral hand used for comparison.
Time Frame
1 year post surgery
Title
Maximal amplitude of the articulation
Description
Measurement of the angle between the axis of the thumb and the index finger, palmar, with a goniometer
Time Frame
1 year post surgery
Title
Maximal amplitude of the articulation
Description
Measurement of the angle between the axis of the thumb and the index finger, radial, with a goniometer
Time Frame
1 year post surgery
Title
Eroded depth
Description
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
Title
Kapandji score
Description
Evaluation of the mobility of the thumb carpal-metacarpal joint
Time Frame
1 year post surgery
Title
metacarpus length
Description
Computed by radiography
Time Frame
1 year post surgery
Title
metacarpal space length
Description
Computed by radiography
Time Frame
1 year post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morgan Gason, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Clinique du Parc Léopold
City
Brussel
ZIP/Postal Code
1040
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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