Comparison of the Safety and Cost of a Simplified Post-Operative Radiograph (SPOR) Protocol

NCT04110470 | Unknown DMC

• 1 other identifier: HS22019 (B2018:067)
• Study Type: interventional
• Target: 1,612
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At six weeks.

Secondary Outcomes (1)

• Patient satisfaction: with a simplified post-operative radiographic protocol.

  At six weeks.

Study Arms (2)

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.

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.

Diagnostic Test: No-Xray

Interventions

X-ray DIAGNOSTIC_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.

Control Group

No-Xray DIAGNOSTIC_TEST

These patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

MeSH Terms

Conditions

Fractures, Bone

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Tudor V Tufescu, BSc, MD, FRCSC

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nigar Sultana

CONTACT

(204) 787-8691; nsultana@hsc.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: October 1, 2019
• Study Start: February 1, 2020
• Primary Completion: February 1, 2024
• Study Completion: May 1, 2024
• Last Updated: October 1, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share