Scaphoid Non-union and Low-intensity Pulsed Ultrasound Trial

Fractures, Ununited Clinical Trial

— SNAPU  

Official title:

A Randomized Controlled Trial Comparing Low-Intensity, Pulsed Ultrasound to Placebo in the Treatment of Operatively Managed Scaphoid Non-Unions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02383160
• Other study ID #: REB13-0849
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 collected to allow for comparison of the groups to ensure similarity.

Patients will be identified during clinic appointment for the initial consultation for surgical fixation of their scaphoid non-union. Patients consenting to surgical fixation will be assessed for inclusion and exclusion criteria and, if appropriate, will be consented and evaluated for baseline range of motion, grip strength, SF-36, DASH and both resting and activity VAS scores. Pre-operative radiographs will be assessed for the degree of wrist arthritis present. No restrictions will be placed on the selection or scheduling of surgical procedures, but the use of other adjuvants such as bone morphogenic protein will be limited.

Bioventus will provide visually identical active and sham Exogen 4000 units. The units will undergo randomization and will be given consecutively numbered labels. Devices will be securely stored at each clinical study center. All clinical centers and personnel involved will be blinded to the randomization. Two weeks post-operatively subjects will attend the cast clinics and be assigned the next sequential device. The device will be applied through a window cut into the standardized cast with a center point over the anatomic snuffbox. This cast will remain in place until the fracture is united on CT or 7 weeks at a minimum.

Treatment will be self-administered for 20 minutes once daily by the patients. The device will be equipped with a system to document compliance with the treatment. Treatment will continue until the subject has greater than 50% cortical bridging on CT scanning with multi-planar reconstruction. Union will be confirmed by both an orthopedic surgeon and an independent musculoskeletal radiologist. Treatment will also be terminated if the subject continues to have non-union present at 6 months postoperatively. Subjects will be assessed for trabecular bridging using serial CT scans until the union is documented. CT scans will take place every 4-6 weeks until union is established. Standard scaphoid and wrist radiographs will be completed within 1 week of the CT scan. Patients who do not have documented union will be classified as persistent non-unions but will be asked to continue and attend clinical follow-ups until 1 year. Patients will be required to attend follow up visits at 2, 8, 12, 16, 24, 52 and 104 weeks for functional assessments. Patients requiring additional surgery such as bone grafting as deemed necessary by their treating surgeon will be scheduled at the surgeon's discretion and the surgery will be recorded as a trial adverse event.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 154
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Ununited
• Nonunion of Fracture of Scaphoid Bone

Intervention

Device:
• Bioventus Exogen 4000: Low-intensity pulsed ultrasound
Active low-intensity pulsed ultrasound
• Sham device
Placebo device with no active therapy

Locations

Country	Name	City	State
Canada	Peter Lougheed Centre	Calgary	Alberta
Canada	South Health Campus	Calgary	Alberta
Canada	Hôpital du Sacré-Coeur de Montreal	Montréal	Quebec
Canada	The Ottawa Hospital (Civic Campus)	Ottawa	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	PanAM Clinic Foundation	Winnipeg	Manitoba

Sponsors (4)

Lead Sponsor	Collaborator
University of Calgary	Bioventus LLC, Calgary Orthopaedic Research and Education Fund, Workers' Compensation Board, Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to radiographic union as evidenced on serial CT scans		up to 52 weeks
Secondary	Percentage of union		8 weeks post-op
Secondary	Percentage of union		12 weeks post-op
Secondary	Rate of change of percent union		8-12 weeks, 12-16 weeks
Secondary	Pattern of partial union on initial CT scan		8 weeks
Secondary	Time to return to work		up to 52 weeks
Secondary	Functional outcomes as measured by range of motion and grip strength	Range of motion measurements of wrist flexion/extension and forearm supination/pronation; grip strength using a grip dynamometer	up to 52 weeks