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NCT Number: 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).

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Key information

Conditions

Rhizarthrosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brugmann, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Regjoint

Device

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

Primary outcomes

  1. 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).

  2. Quick-DASH questionnaire

    Time frame: 1 year post surgery

    Evaluation of the return to daily life activities (work and sport)

  3. Prehension force

    Time frame: 1 year post surgery

    Measured with a Standard Dynamometer or Hydraulic Pinch Gauge, with the contralateral hand used for comparison.

  4. Maximal amplitude of the articulation

    Time frame: 1 year post surgery

    Measurement of the angle between the axis of the thumb and the index finger, palmar, with a goniometer

  5. Maximal amplitude of the articulation

    Time frame: 1 year post surgery

    Measurement of the angle between the axis of the thumb and the index finger, radial, with a goniometer

  6. Eroded depth

    Time frame: 1 year post surgery

    Evaluation of the bone erosion by means of a radiography (face/profile/oblique). Measure of the degree of subluxation/dislocation.

  7. Kapandji score

    Time frame: 1 year post surgery

    Evaluation of the mobility of the thumb carpal-metacarpal joint

  8. metacarpus length

    Time frame: 1 year post surgery

    Computed by radiography

  9. metacarpal space length

    Time frame: 1 year post surgery

    Computed by radiography

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 25, 2017
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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