RecruitingACTRN12619000770167

A clinical registry to monitor outcomes of upper limb pathology (PRULO)

Prospective collection of outcomes for patients undergoing surgery of the upper limb (shoulder, elbow, hand or wrist)


Sponsor

Mr Kevin Eng

Enrollment

3,000 participants

Start Date

Oct 13, 2020

Study Type

Observational

Conditions

Summary

This is an implementation study, aiming to design and implement a clinical outcomes orthopaedic registry for patients presenting to a single centre practice with upper limb pathologies. The purpose of this registry is to report patient outcomes after treatment through a prospective, consecutive observational cohort study design. This clinical registry will collate and store patient outcomes collected routinely as part of the standard clinical pathway for upper limb pathology treatments. Outcomes will include objective joint function, patient reported outcomes (pain, satisfaction, quality of life), radiological findings and rates of revision surgery or complications. Recruitment will include all patients presenting with upper limb pathology to the principal or associate investigators at a single clinical practice (Geelong Orthopaedics). Patients will undergo standard of care consultation for diagnosis and treatment, including the collection of demographic data, patient medical history, radiological findings, pathology, and functional analysis. Patient evaluation will be completed routinely as part of the standard clinical pathway performed by the principal and associate investigators via the consulting rooms at Geelong Orthopaedics or hospital clinics. Patients will in addition be requested to complete a set of questionnaires (EQ-5D, Oxford shoulder scores (Pain and Instability scores), Quick DASH (upper limb function score), American Shoulder and Elbow Society (ASES) Score, Western Ontario Rotator Cuff (WORC) Score) and return to activity questions to enable evaluation of patient reported outcomes and complete physical assessments as part of the post- treatment follow up. The clinical outcomes of individual patients will be monitored for up to 5 years.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This is a clinical outcomes registry — a long-term database that tracks how patients with shoulder, elbow, hand, and wrist problems do after treatment at a single orthopaedic practice (Geelong Orthopaedics). Rather than testing a specific treatment, this registry collects detailed information about a wide range of patients over time to understand what really works in the real world. Participants will undergo their normal clinical care but will also be asked to complete a set of questionnaires about pain, function, and quality of life at various points over up to five years. The information collected will include X-ray findings, details of any surgery or procedures, and how patients feel about their recovery. Anyone aged 16 or over who is receiving treatment for an upper limb condition at Geelong Orthopaedics by one of the participating surgeons is eligible, as long as they consent to their information being used for research. People with certain neurological or psychiatric conditions that prevent them from completing questionnaires are excluded. This type of registry research is essential for understanding long-term outcomes and improving future treatment decisions in orthopaedic care.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients presenting with pathologies of the upper limb and referred to specialist orthopaedic review are requested to provide consent to inclusion in the study (incorporating access to records relatin

Patients presenting with pathologies of the upper limb and referred to specialist orthopaedic review are requested to provide consent to inclusion in the study (incorporating access to records relating to consultations and procedures undertaken by the Surgeon, and patient completion of pre and postoperative questionnaires). Orthopaedic interventions consist of the following: 1. Patients diagnosed with rotator cuff pathology (subacromial impingement; tendinopathy; tear): Treated with non-operative management or surgical repair. Followed for a minimum duration of 2 years. 2. Patients diagnosed with glenohumeral arthritis of any aetiology: Treated with arthroscopic surgery or total shoulder arthroplasty. Followed for a minimum duration of 2 years. 3. Patients diagnosed with either a recent shoulder dislocation or clinically defined glenohumeral instability: Treated with surgical stabilisation. Followed for a minimum duration of 2 years. 4. Patients diagnosed with frozen shoulder/adhesive capsulitis managed non-operatively or treated surgically. Followed for a minimum duration of 2 years. 5. Patients diagnosed with a shoulder pathology not fitting matching other cohorts. Managed nonoperatively or treated surgically. Followed for a minimum duration of 2 years. 6. Patients diagnosed with an elbow pathology of any aetiology diagnosed by the consulting surgeon. Managed nonoperatively or treated surgically. Followed for a minimum duration of 2 years. 7. Patients diagnosed with carpal tunnel syndrome treated with arthoscopic carpal tunnel release. Followed for a minimum duration of 2 years. 8. Patients diagnosed with a hand or wrist pathology not matching other cohorts. Managed nonoperatively or treated surgically. Followed for a minimum duration of 2 years.


Locations(1)

VIC, Australia

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ACTRN12619000770167


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