Nonunion of Fracture of Scaphoid BoneSNAPUNCT02383160
Scaphoid Non-union and Low-intensity Pulsed Ultrasound Trial
A study testing Bioventus Exogen 4000: Low-intensity pulsed ultrasound in people with Nonunion of Fracture of Scaphoid Bone and Fractures, Ununited, run by University of Calgary at 6 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Nonunion of Fracture of Scaphoid Bone, Fractures, Ununited
- What is being tested?
- Bioventus Exogen 4000: Low-intensity pulsed ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 6 sitesCanada
- Study dates
- Sep 2014to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
South Health Campus
Calgary, Alberta, T3M1M4
Peter Lougheed Centre
Calgary, Alberta
Hôpital du Sacré-Coeur de Montreal
Montreal, Quebec
The Ottawa Hospital (Civic Campus)
Ottawa, Ontario
St. Paul's Hospital
Vancouver, British Columbia
PanAM Clinic Foundation
Winnipeg, Manitoba
About this study
Official title: A Randomized Controlled Trial Comparing Low-Intensity, Pulsed Ultrasound to Placebo in the Treatment of Operatively Managed Scaphoid Non-Unions
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.
Read the detailed 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.
- Being tested
- Bioventus Exogen 4000: Low-intensity pulsed ultrasound, Sham device
- Keywords
- Low-intensity pulsed ultrasound, Nonunion, Scaphoid, Operative
- Medical subject headings
- Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioventus Exogen 4000: Low-intensity pulsed ultrasoundDevice
Also called Bioventus Exogen 4000
Active low-intensity pulsed ultrasound
Sham deviceDevice
Also called Bioventus Exogen 4000 Sham Unit
Placebo device with no active therapy
| Study group | Role | What they receive |
|---|---|---|
| Active LIPUS Unit | Active comparator | Low-intensity pulsed ultrasound treatment 20 minutes/day until the fracture is deemed united clinically and on CT scan. Receives: Device: Bioventus Exogen 4000: Low-intensity pulsed ultrasound |
| Sham LIPUS Unit | Sham comparator | Sham device treatment 20 minutes/day until the fracture is deemed united clinically and on CT scan. Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to radiographic union as evidenced on serial CT scans
Measured: up to 52 weeks
Secondary outcomes (6)
Percentage of union
Measured: 8 weeks post-op
Percentage of union
Measured: 12 weeks post-op
Rate of change of percent union
Measured: 8-12 weeks, 12-16 weeks
Pattern of partial union on initial CT scan
Measured: 8 weeks
Time to return to work
Measured: up to 52 weeks
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
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startSep 2014
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonunion of Fracture of Scaphoid BoneStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Workers' Compensation Board, Alberta, Calgary Orthopaedic Research and Education Fund, Bioventus LLC
- Responsible party
- Principal investigator, Neil White, University of Calgary
- Investigators
- Neil White, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383160
- Sponsor's protocol ID
- REB13-0849
- Acronym
- SNAPU
- Status last verified
- May 2022
- First submitted
- 26 Feb 2015
- Last updated
- 18 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Low-Intensity, Pulsed Ultrasound to Placebo in the Treatment of Operatively Managed Scaphoid Non-Unions
- ClinicalTrials.gov ID
- NCT02383160
- Acronym / sponsor ID
- SNAPU / REB13-0849
- Keywords
- Low-intensity pulsed ultrasound, Nonunion, Scaphoid, Operative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Workers' Compensation Board, Alberta, Calgary Orthopaedic Research and Education Fund, Bioventus LLC
- Study start
- Sep 2014
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active LIPUS Unit | Active comparator | Device: Bioventus Exogen 4000: Low-intensity pulsed ultrasoundLow-intensity pulsed ultrasound treatment 20 minutes/day until the fracture is deemed united clinically and on CT scan. |
| Sham LIPUS Unit | Sham comparator | Device: Sham deviceSham device treatment 20 minutes/day until the fracture is deemed united clinically and on CT scan. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioventus Exogen 4000: Low-intensity pulsed ultrasoundAlso: Bioventus Exogen 4000Active low-intensity pulsed ultrasound | Device | Active LIPUS Unit |
| Sham deviceAlso: Bioventus Exogen 4000 Sham UnitPlacebo device with no active therapy | Device | Sham LIPUS Unit |
Primary outcome
Time to radiographic union as evidenced on serial CT scans
Time frame: up to 52 weeks
6 secondary outcomes
Percentage of union
Time frame: 8 weeks post-op
Percentage of union
Time frame: 12 weeks post-op
Rate of change of percent union
Time frame: 8-12 weeks, 12-16 weeks
Pattern of partial union on initial CT scan
Time frame: 8 weeks
Time to return to work
Time frame: up to 52 weeks
Functional outcomes as measured by range of motion and grip strength
Time frame: up to 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil White, MD principal investigator
University of Calgary
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioventus Exogen 4000: Low-intensity pulsed ultrasound in people with Nonunion of Fracture of Scaphoid Bone and Fractures, Ununited, run by University of Calgary at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to radiographic union as evidenced on serial CT scans (time frame: up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.