Completed

NCT Number: NCT02676999

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

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.

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Key information

Conditions

Scheker Total Distal Radioulnar Joint Prosthesis

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich, Center for Reconstructive Surgery

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Implantation of a Scheker total distal radioulnar joint prosthesis

Procedure

Primary outcomes

Primary outcomes of this study are active DRUJ range of motion (pronation and supination) and weight-bearing ability in neutral and pronated position.

Time frame: Follow-up time between 12-60 months after primary implantation of the Scheker prothesis

Secondary outcomes

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.

Time frame: Follow- up time between 12-60 months after primary implantation of the Scheker prothesis

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2020
First posted: Feb 9, 2016
Registry last updated: Nov 10, 2020

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.