Scaphoid Non-union and Low-intensity Pulsed Ultrasound Trial

Launched by UNIVERSITY OF CALGARY · Mar 6, 2015

Keywords

ClinConnect Summary

This is a prospective, double-blind, multicentered, randomized controlled trial to determine the effectiveness of low-intensity pulsed ultrasound in decreasing the time to union of scaphoid non-unions after operative fixation as measured by serial CT scanning. Multiple centers across Canada will be involved in the study. Blinding will include patients, surgeons, research assistants, as well as all data handlers and analysts until trial completion or mid-term analysis. Baseline demographics including age, hand dominance, work status and medical co-morbidities of the patients will be collecte...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject has a scaphoid fracture \> 3 months-old with at least one feature of non-union including, collapse or humpback deformity, sclerosis at the fracture site or cystic changes evident on pre-operative diagnostic imaging
• • Subject has consented to surgical fixation at surgeon discretion
• • Subject is willing and has the ability to operate the LIPUS device for at least four to six months post-operatively
• Exclusion Criteria:
• • Subject with concomitant fracture or dislocation of another ipsilateral carpal bone, distal radius or ulna, or bilateral scaphoid fractures
• • Subject has an open or pathological fracture
• • Subject who are actively receiving treatment of a rheumatologic disorder with a biologic medication or other arthritic condition
• • Subject has a history of fibrous dysplasia, chronic renal failure, Paget's disease, osteopetrosis or other impairing disease/condition of the musculoskeletal system
• • Subject with an active infection of the affected limb
• • Subject with a high risk of death within the follow up period
• • Subject is a prisoner or at high risk of incarceration
• • Subject who are unlikely to complete follow-up (no fixed address, states they are unlikely to complete follow up, psychiatric condition at surgeon discretion)
• • Subject has cognitive impairment or language difficulties that would impede the completion of questionnaires
• • Subject who are pregnant or anticipate getting pregnant