---
title: Long-term Evaluation of Primary Trapeziectomy and Placement of a RegJoint Implant in the Treatment of Rhizarthrosis
nct_id: NCT03320291
overall_status: COMPLETED
phase: NA
sponsor: Brugmann University Hospital
study_type: INTERVENTIONAL
primary_condition: Rhizarthrosis
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03320291.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03320291"
ct_last_update_post_date: 2019-04-17
last_seen_at: "2026-05-12T06:05:02.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Long-term Evaluation of Primary Trapeziectomy and Placement of a RegJoint Implant in the Treatment of Rhizarthrosis

**NCT ID:** [NCT03320291](https://clinicaltrials.gov/study/NCT03320291)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 27
- **Lead Sponsor:** Brugmann University Hospital
- **Conditions:** Rhizarthrosis
- **Start Date:** 2017-11-01
- **Completion Date:** 2018-10-10
- **CT.gov Last Update:** 2019-04-17

## 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).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Regjoint** (EXPERIMENTAL)

## Interventions

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

## Primary Outcomes

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

## Locations (2)

- CHU Brugmann, Brussels, Belgium
- Clinique du Parc Léopold, Brussels, Belgium

## Recent Field Changes (last 30 days)

- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.chu brugmann|brussels||belgium` — added _(2026-05-12)_
- `locations.clinique du parc léopold|brussels||belgium` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03320291*  
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