Last reviewed · How we verify
NCT05805774: pDIFFIR
pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement
NA trial testing Distal Femur Replacement in Distal Femur Fracture in 148 participants. Currently enrolling.
10 December 2030
Quick facts
| Lead sponsor | Unity Health Toronto |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 148 |
| Start date | 17 October 2025 |
| Primary completion | 10 December 2030 |
| Estimated completion | 10 December 2032 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Distal Femur Replacement
- Surgical fixation
Conditions studied
- Distal Femur Fracture — all drugs for Distal Femur Fracture →
- Periprosthetic Fracture Around Prosthetic Joint Implant Knee — all drugs for Periprosthetic Fracture Around Prosthetic Joint Implant Knee →
- Knee Fracture — all drugs for Knee Fracture →
Sponsor
Unity Health Toronto — full company profile →
Who can join
65 and older, any sex, with Distal Femur Fracture or Periprosthetic Fracture Around Prosthetic Joint Implant Knee. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Periprosthetic distal femur fractures are a significant source of morbidity and mortality for elderly patients. One treatment option involved a surgical fixation with plates or nails, screws and cables/wires along the side of your fractured bone. The second method consists in replacing your knee joint with an artificial knee prosthesis (artificial knee joint). The primary objective is to determine if acute distal femur replacement improves knee pain and functional outcomes compared to surgical fixation. Secondary outcomes are mortality, reoperation, complications, post-operative pain and quality of life. A health economic analysis will be conducted to assess the cost-effectiveness of both treatments. A total of 148 patients (74/group) will be enrolled in the study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05805774
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Distal Femur Fracture
Currently open trials in the same condition.
- NCT07280169 — Carbo-fix Lateral Plate Devices and Standard Plate-Nail Constructs in Distal Femur Fractures · NA · recruiting
- NCT06028971 — Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series · active not recruiting
- NCT05792189 — Distal Femur Fx: ORIF(Open Reduction and Internal Fixation) vs DFR (Distal Femur Replacement Total Knee Arthroplasty) · NA · recruiting
- NCT04076735 — DIFFIR - Geriatric Distal Femur Fixation Versus Replacement · NA · recruiting
Other Unity Health Toronto trials
Trials by the same sponsor.
- NCT07507409 — Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients · Phase 4 · not yet recruiting
- NCT07455487 — First Appendectomy Using Revolve Surgical Robotic Arm · NA · not yet recruiting
- NCT07301632 — Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial · Phase 2 · recruiting
- NCT07314905 — Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp) · Phase 3 · not yet recruiting
- NCT06571916 — Brief Skills for Safer Living (Brief-SfSL) · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05805774 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Unity Health Toronto
- Last refreshed: 18 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05805774.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing