Preliminaries

Introduction

This document is a protocol for a human clinical research registry. This registry is conducted according to the framework published by the Australian Commission for Safety and Quality in Healthcare, National Health and Medical Research Council statement on research conduct, Good Clinical Practice (GCP) and the The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) framework.

Rationale

The proposed registry is necessary to monitor: i) the natural history of upper limb pathologies occurring in the general population and ii) the short-term and long-term patient outcomes associated with these pathologies and contemporary treatment options.

Primary aim

To objectively assess patient-centred outcomes of surgical management for upper limb pathologies presenting to Geelong Orthopaedics.

Secondary aims

● To investigate the predictors of poor outcomes following definitive surgical treatment.

● To describe patient outcomes based on a consistent framework defining treatment success.

Registry overview

Figure 1 summarises the structure of this registry manual: Section 1 contains the Registry Framework, Section 2 describes the Registry Cohorts, and Section 3 contains information on Quality Assurance and Data Management.