Fractures, BoneSPORNCT04110470
Comparison of the Safety and Cost of a Simplified Post-Operative Radiograph (SPOR) Protocol
A study testing X-ray and No-Xray in people with Fractures, Bone and Fracture Complications, run by University of Manitoba.
Trial summary
The standard post-operative radiographic protocol for the monitoring of fractures at Health Sciences Centre includes post-operative in hospital radiographs as well as radiographs at the two week follow up appointment. This is in addition to good quality intra-operative radiographs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures, Bone, Fracture Complications, Xray Complication
- What is being tested?
- X-ray and No-Xray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,612 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 1 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one lag screw for each fracture line
- At least one compression plate across each fracture line
- Locked intramedullary nail
- Articular/peri-articular fracture with antiglide/under-contoured plate
- Tension band technique (plate included) in simple fracture pattern
- Operating surgeon is confident in fixation construct, despite non-load sharing criteria.
Who cannot join
- Fracture >21 days old
- Age <18 years, or open growth plates
- Articular fracture with depression
- Multiple orthopaedic fractures
- History or radiographic appearance of osteoporosis/osteopenia or poor operative bone quality
- Likely difficulty with follow-up in first 6 weeks
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Definitive Study for Non-inferiority Randomized Control Trial Comparing the Safety and Cost of a Simplified Post-Operative Radiographic (SPOR) Protocol for Selected Fractures
The standard post-operative radiographic protocol for the monitoring of fractures at Health Sciences Centre includes post-operative in hospital radiographs as well as radiographs at the two week follow up appointment. This is in addition to good quality intra-operative radiographs. With current operative techniques and implants, orthopaedic surgeons can achieve reliably stable internal fixation. In fact, patients are often allowed to take weight through the fractured limb immediately post-operatively. In these cases, redundant post-operative radiographs likely represent an avoidable cost to the system financially, and an avoidable cost to the patient in additional time spent in hospital and unnecessary radiation exposure.
- Conditions
- Fractures, Bone, Fracture Complications, Xray Complication
- Being tested
- X-ray, No-Xray
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-rayDiagnostic test
Patients will receive standard radiographs post-operative day one or two in hospital, as well as radiographs in clinic at two and six weeks.
No-XrayDiagnostic test
These patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients will receive standard radiographs post-operative day one or two in hospital, as well as radiographs in clinic at two and six weeks. Receives: Diagnostic Test: X-ray |
| Treatment Group | Experimental | These patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated. Receives: Diagnostic Test: No-Xray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of a simplified post-operative radiographic protocol for fractures with stable fixation.
Incidence of adverse events with a simplified X-ray protocol within the first six weeks of treatment compared to the standard protocol.
Adverse events are defined as radiographic signs of implant related failure within the first six weeks of treatment and noted on the six week radiographs.
Measured: At six weeks.
Cost-effectiveness of a simplified post-operative radiographic protocol for fractures with stable fixation.
Cost of a simplified X-ray protocol compared to the standard protocol. Cost-effectiveness will be measured by calculating cost of x-ray, patient care and time spent by patients in clinic.
Measured: At six weeks.
Secondary outcomes (1)
Patient satisfaction: with a simplified post-operative radiographic protocol.
A validated 17 question survey tool is used with each question in a 10 centimeter visual analog scale format. Examples of scale ranges (0-10) are provided. The following is a list of some questions asked of participants:
- Staff don't seem to listen to anything I tell them during my consultation. Agree Disagree
- I feel that I'm in good hands when I come to the clinic. Agree Disagree
- I'm always given a clear explanation of why I am having tests done. Agree Disagree
- There are some things about my care in the clinic which could be improved. Agree Disagree
- The person I see in clinic really
Measured: At six weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Feb 2020 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,612 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tudor V Tufescu, BSc, MD, FRCSC, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110470
- Sponsor's protocol ID
- HS22019 (B2018:067)
- Acronym
- SPOR
- Status last verified
- Oct 2018
- First submitted
- 22 Nov 2018
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definitive Study for Non-inferiority Randomized Control Trial Comparing the Safety and Cost of a Simplified Post-Operative Radiographic (SPOR) Protocol for Selected Fractures
- ClinicalTrials.gov ID
- NCT04110470
- Acronym / sponsor ID
- SPOR / HS22019 (B2018:067)
- Conditions
- Fractures, Bone, Fracture Complications, Xray Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,612 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 1 Oct 2019 (actual)
- 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.
The standard post-operative radiographic protocol for the monitoring of fractures at Health Sciences Centre includes post-operative in hospital radiographs as well as radiographs at the two week follow up appointment. This is in addition to good quality intra-operative radiographs. With current operative techniques and implants, orthopaedic surgeons can achieve reliably stable internal fixation. In fact, patients are often allowed to take weight through the fractured limb immediately post-operatively. In these cases, redundant post-operative radiographs likely represent an avoidable cost to the system financially, and an avoidable cost to the patient in additional time spent in hospital and unnecessary radiation exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Diagnostic Test: X-rayPatients will receive standard radiographs post-operative day one or two in hospital, as well as radiographs in clinic at two and six weeks. |
| Treatment Group | Experimental | Diagnostic Test: No-XrayThese patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least one lag screw for each fracture line
- At least one compression plate across each fracture line
- Locked intramedullary nail
- Articular/peri-articular fracture with antiglide/under-contoured plate
- Tension band technique (plate included) in simple fracture pattern
Key exclusion criteria (6 listed)
- Fracture >21 days old
- Age <18 years, or open growth plates
- Articular fracture with depression
- Multiple orthopaedic fractures
- History or radiographic appearance of osteoporosis/osteopenia or poor operative bone quality
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 |
|---|---|---|
| X-rayPatients will receive standard radiographs post-operative day one or two in hospital, as well as radiographs in clinic at two and six weeks. | Diagnostic test | Control Group |
| No-XrayThese patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated. | Diagnostic test | Treatment Group |
Primary outcome
Safety of a simplified post-operative radiographic protocol for fractures with stable fixation.
Time frame: At six weeks.
Incidence of adverse events with a simplified X-ray protocol within the first six weeks of treatment compared to the standard protocol. Adverse events are defined as radiographic signs of implant related failure within the first six weeks of treatment and noted on the six week radiographs.
Cost-effectiveness of a simplified post-operative radiographic protocol for fractures with stable fixation.
Time frame: At six weeks.
Cost of a simplified X-ray protocol compared to the standard protocol. Cost-effectiveness will be measured by calculating cost of x-ray, patient care and time spent by patients in clinic.
1 secondary outcome
Patient satisfaction: with a simplified post-operative radiographic protocol.
Time frame: At six weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Tudor V Tufescu, BSc, MD, FRCSC principal investigator
University of Manitoba
Questions about this trial
What is this clinical trial studying?
A study testing X-ray and No-Xray in people with Fractures, Bone and Fracture Complications, run by University of Manitoba.
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 6 inclusion and 6 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 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Nigar Sultana ((204) 787-8691, nsultana@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of a simplified post-operative radiographic protocol for fractures with stable fixation. (time frame: At six weeks.). The study lists 2 primary outcomes in all. 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 1 Oct 2019.