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)
Mr Kevin Eng
3,000 participants
Oct 13, 2020
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
Plain Language Summary
Simplified for easier understanding
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.
Interested in this trial?
Get notified about updates and connect with the research team.
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 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)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12619000770167