Clinical and Radiographical Analysis of the Distal Radioulnar Joint Following Implantation of a Scheker Total Distal Radioulnar Joint Prosthesis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02676999

Enrollment

Registered

2016-02-09

Start date

2014-09-30

Completion date

2020-06-30

Last updated

2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scheker Total Distal Radioulnar Joint Prosthesis

Brief summary

This project is set to describe by objective measures as the range of motion and weight-bearing ability of the distal radioulnar joint one to five years after primary implantation of a Scheker total distal radioulnar joint prosthesis.The range of motion and stability of the distal radioulnar joint (DRUJ) are important outcomes to preserve function, especially the pronation and supination. Unlike other ulnar endoprostheses that replace only the ulnar head, the Scheker prosthesis replaces the ulnar head, resurfaces the lesser sigmoid notch, and is semi-constrained in design.

Interventions

PROCEDUREImplantation of a Scheker total distal radioulnar joint prosthesis

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patient treated with a Scheker total distal radioulnar joint prosthesis and with a follow-up time between 12 and 60 months after primary implantation * Patient willing and able to give written informed consent to participate in the study

Exclusion criteria

* Inflammatory disease (e.g. rheumatoid arthritis) * Pregnant women * German language barrier to complete the questionnaires * Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder) * Legal incompetence * Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study

Design outcomes

Primary

Measure	Time frame
Primary outcomes of this study are active DRUJ range of motion (pronation and supination) and weight-bearing ability in neutral and pronated position.	Follow-up time between 12-60 months after primary implantation of the Scheker prothesis

Secondary

Measure	Time frame
Secondary outcomes of this study are radiological parameters, pain level by Visual Analog Scale, objective functional parameters (passive stability, grip strength), subjective functional parameters, and complications affecting the examined wrist.	Follow- up time between 12-60 months after primary implantation of the Scheker prothesis

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026