PRONT-O
Research type
Research Study
Full title
Patient Reported Outcomes following Nerve Transfer (Oberlin’s)
IRAS ID
337288
Contact name
Hazel Brown
Contact email
Sponsor organisation
royal national orthopaedic hospital
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 7 months, 1 days
Research summary
Brachial Plexus injuries affecting the musculocutaneous nerve result in a loss of nerve supply to the elbow flexors (biceps and brachialis). In these situations, the ability to actively bend the elbow is lost. This has a profound effect on patients’ lives as it renders the individual unable to do day-to-day activities with their affected arm such as brushing their teeth, bringing food and drink to their mouth and lifting and placing objects.
A special type of nerve surgery (an Oberlin’s nerve transfer) can be carried out to allow nerves to regrow into the affected muscles. Historically, the outcomes of this surgery have been based on what strength the person gets back in their arm, measured by a clinician or researcher within the hospital or research environment. However, the outcome of surgery for a patient goes beyond what clinicians assesses. Self-reported recovery has been highlighted by our PPI group as something that nerve injured patients would like to be formalised (so that they do not have to wait for a hospital appointment to be able to see their progress). This study aims to address this perceived un-met need through the validation of a patient-reported outcome measure (PROM) which has been developed with feedback from patients.
The study will recruit up to 110 individuals who have had an Oberlin’s nerve transfer (at the host institution) as a purposeful sample to investigate for:
1.Correlation between the PROM and clinician/researcher measured strength of the participant (tested using hand-held dynamometry).
2.The responsiveness of the PROM to detect changes in the patient’s recovery over time.
3.Assess the reliability of the PROM to give accurate information.
The study will take place over a time period of 6 years to fully assess these components in a staged approach.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0052
Date of REC Opinion
15 Mar 2024
REC opinion
Favourable Opinion