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

Completed

• Conditions: Scheker Total Distal Radioulnar Joint Prosthesis

• Registration Number: NCT02676999
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-01-14
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-09
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Last Update Submitted: 2020-11-09
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Zurich, Center for Reconstructive Surgery; 🇨🇭 Zurich, ZH, Switzerland