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

Rhizarthrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320291
• Other study ID #: CHUB-Regjoint_TMC
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: October 10, 2018

Study information

• Verified date: April 2019
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 10, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Rhizarthrosis

Intervention

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

Locations

Country	Name	City	State
Belgium	Clinique du Parc Léopold	Brussel
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

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