DIFFIR - Geriatric Distal Femur Fixation Versus Replacement

NCT04076735 | Recruiting

• 1 other identifier: 19-145
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The current standard of care for most intra-articular distal femur fractures (above the knee joint) in geriatric patients is a surgical fixation using plates and screws to hold the fracture pieces in the correct position, until the fracture as healed. However, surgical fixation of these complex fractures in geriatric patients, is associated with significant complications, such as non-union (when the broken bone does not heal properly), infection and the need for revision surgery. Additionally, surgical fixation requires prolonged immobilization of of the affected limb (typically around 6-12 weeks post-operatively), which can lead to disability and other complications. Geriatric patients, especially those frail and with cognition impairment, are unable to adhere to the immobilization restrictions, which leads to an increased risk of fixation failure (broken bone does not heal). Another treatment option for those patients is an acute distal femoral replacement (artificial knee), where damaged parts of the knee joint are replaced with artificial prosthesis. This procedure allows patients to walk immediately after the surgery and faster return to previous level of function, therefore avoiding the complications for immobilization. There is a lack of guideline and evidence to suggest which surgical technique is best to provide superior function outcomes, lower complications and reduced costs. The proposed study seeks to answer this question by performing a large clinical trial comparing knee replacement versus surgical fixation in geriatric patients with distal femur fracture.

Conditions

Distal Femur Fracture

Keywords

Distal Femur Fracture; Geriatric fracture

Outcome Measures

Primary Outcomes (1)

• Oxford Knee Score (OKS)

  A short questionnaire consists of 12 questions ranging from 0 to 48 points, designed to assess function and pain after knee replacement surgery. Higher values represent a better outcome. Scores between 40-48 indicate satisfactory joint function.

  Our primary outcome is knee pain and function as measured by repeated measures of the Oxford Knee Score at 3, 6, 9 and 12 -months post-surgery to detect a 5 point improvement on the OKS with 0.5 correlation between assessments.

Secondary Outcomes (6)

• Daily morphine equivalent usage while in hospital

  The outcome will be assessed daily from the day of the surgery until the patient gets discharge from the hospital (24 hours up to 7 days)

• Visual Analog Pain Scale (VAS)

  Pain scale will be assessed immediately after surgery at 24 hours 48 hours, and then at each follow up visit at 3, 6, 9, 12, and 24 months post-surgery

• Health status and quality of life - EQ-5D questionnaire

  Questionnaire will be completed by patients at 3, 6, 9, 12, and 24 months post-surgery

• knee range of movement (ROM)

  Test will be completed at each follow up visit at 3, 6,12 and 24 months post surgery

• Timed Up and Go (TUG) test

  Test will be completed at each follow up visit at 3, 6, 12 and 24 months post surgery

Study Arms (2)

Distal femoral replacement (DFR)

EXPERIMENTAL

Distal femoral replacement will be performed by excising the distal portion of the femur (up to two thirds) and replacing with a prosthesis incorporating a hinged total knee replacement. Surgical approach and implant selection will be at the discretion of the treating surgeon and within the standard of care. Surgeons performing this procedure will be qualified by training and experience in arthroplasty.

Procedure: Distal femoral replacement

Surgical Fixation (ORIF)

ACTIVE COMPARATOR

Surgical fixation of the distal femoral fracture will be performed with the goals of obtaining and maintaining anatomic reduction and stable fixation of the distal portion of the femur. Surgical approach and implant selection for the surgical fixation (ORIF) will be at the discretion of the treating surgeon and within the standard of care. Surgeons performing this procedure will be qualified by training and experience in trauma of the knee.

Procedure: Surgical Fixation (ORIF)

Interventions

Distal femoral replacement PROCEDURE

The distal portion of the femur (up to two thirds) is excised and replaced by a endoprosthesis incorporating a hinged total knee replacement.

Distal femoral replacement (DFR)

Surgical Fixation (ORIF) PROCEDURE

A trained orthopaedic surgeon uses open or minimally invasive reduction techniques and achieves stable fixation with internal fixation devices (plates/screws or intramedullary nail) to restore structural integrity and alignment of the distal femur

Also known as: open reduction and internal fixation

Surgical Fixation (ORIF)

Eligibility Criteria

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

You may qualify if:

• Male and female patients
• years and older
• Isolated fracture of the distal femur (Classification 33)
• Fracture is amendable to both treatments
• Fracture is acute (within 2 weeks from time of injury)
• Patient was ambulatory (with or without walking aids) prior to the injury
• Independent or moderately frail with score of 3 to 6 on the Clinical Frailty Scale
• Patient is able to read and understand English, French, or Spanish
• Patient or substitute decision maker is able to provide written informed consent to participate in the study

You may not qualify if:

• Active or previous infection around the fracture (soft tissue or bone)
• Open fracture
• Bilateral femur fractures
• Major vascular injuries requiring intervention, compartment syndrome and major neurologic injuries
• Pathological fracture excluding osteoporosis
• Previous surgical fixation or total knee replacement of the distal femur or proximal tibia
• Previous surgical fixation or hemi/total replacement of the hip
• Current or previous extensor mechanism (patellar tendon, quadriceps tendon, or patella fracture) disruption or repair
• Polytrauma (Injury Severity Score \> 15) or any associated major injuries of the lower extremities
• Previous medical diagnosis of dementia
• Medical or surgical contra-indication to surgery

Sponsors & Collaborators

• Unity Health Toronto: lead
• Mount Sinai Hospital, Canada: collaborator
• NYU Langone Health: collaborator
• OrthoCincy Orthopaedics & Sports Medicine: collaborator
• University of California: collaborator
• Hospital for Special Surgery, New York: collaborator
• Stanford University: collaborator
• Cedars-Sinai Medical Center: collaborator
• Thunder Bay Regional Health Sciences Centre: collaborator
• University of California, San Francisco: collaborator
• University of Arkansas: collaborator
• University of Calgary: collaborator
• Ascension Health: collaborator
• University of Otago: collaborator
• Gold Coast University Hospital, Australia: collaborator
• Humber River Hospital: collaborator
• Brigham and Women's Hospital: collaborator
• Queen Elizabeth II Health Sciences Centre: collaborator
• Hamilton Health Sciences Corporation: collaborator
• Oregon Health and Science University: collaborator
• Ottawa Hospital Research Institute: collaborator
• Yale New Haven Health System Center for Healthcare Solutions: collaborator

Study Sites (1)

St Michael's Hospital - Unity Health Toronto

Toronto, Ontario, Canada

RECRUITING

Related Publications (14)

• Heiney JP, Barnett MD, Vrabec GA, Schoenfeld AJ, Baji A, Njus GO. Distal femoral fixation: a biomechanical comparison of trigen retrograde intramedullary (i.m.) nail, dynamic condylar screw (DCS), and locking compression plate (LCP) condylar plate. J Trauma. 2009 Feb;66(2):443-9. doi: 10.1097/TA.0b013e31815edeb8.

  PMID: 19204519 BACKGROUND

• Papadopoulos EC, Parvizi J, Lai CH, Lewallen DG. Total knee arthroplasty following prior distal femoral fracture. Knee. 2002 Dec;9(4):267-74. doi: 10.1016/s0968-0160(02)00046-7.

  PMID: 12424033 BACKGROUND

• Chen F, Li R, Lall A, Schwechter EM. Primary Total Knee Arthroplasty for Distal Femur Fractures: A Systematic Review of Indications, Implants, Techniques, and Results. Am J Orthop (Belle Mead NJ). 2017 May/Jun;46(3):E163-E171.

  PMID: 28666042 BACKGROUND

• Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

  PMID: 16129869 BACKGROUND

• Stevenson M, Segui-Gomez M, Lescohier I, Di Scala C, McDonald-Smith G. An overview of the injury severity score and the new injury severity score. Inj Prev. 2001 Mar;7(1):10-3. doi: 10.1136/ip.7.1.10.

  PMID: 11289527 BACKGROUND

• Marsh JL, Slongo TF, Agel J, Broderick JS, Creevey W, DeCoster TA, Prokuski L, Sirkin MS, Ziran B, Henley B, Audige L. Fracture and dislocation classification compendium - 2007: Orthopaedic Trauma Association classification, database and outcomes committee. J Orthop Trauma. 2007 Nov-Dec;21(10 Suppl):S1-133. doi: 10.1097/00005131-200711101-00001.

  PMID: 18277234 BACKGROUND

• Kammerlander C, Riedmuller P, Gosch M, Zegg M, Kammerlander-Knauer U, Schmid R, Roth T. Functional outcome and mortality in geriatric distal femoral fractures. Injury. 2012 Jul;43(7):1096-101. doi: 10.1016/j.injury.2012.02.014. Epub 2012 Mar 8.

  PMID: 22405338 BACKGROUND

• Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg Br. 1998 Jan;80(1):63-9. doi: 10.1302/0301-620x.80b1.7859.

  PMID: 9460955 BACKGROUND

• Wright NC, Looker AC, Saag KG, Curtis JR, Delzell ES, Randall S, Dawson-Hughes B. The recent prevalence of osteoporosis and low bone mass in the United States based on bone mineral density at the femoral neck or lumbar spine. J Bone Miner Res. 2014 Nov;29(11):2520-6. doi: 10.1002/jbmr.2269.

  PMID: 24771492 BACKGROUND

• Myers P, Laboe P, Johnson KJ, Fredericks PD, Crichlow RJ, Maar DC, Weber TG. Patient Mortality in Geriatric Distal Femur Fractures. J Orthop Trauma. 2018 Mar;32(3):111-115. doi: 10.1097/BOT.0000000000001078.

  PMID: 29462121 BACKGROUND

• Smith JR, Halliday R, Aquilina AL, Morrison RJ, Yip GC, McArthur J, Hull P, Gray A, Kelly MB; Collaborative - Orthopaedic Trauma Society (OTS). Distal femoral fractures: The need to review the standard of care. Injury. 2015;46(6):1084-8. doi: 10.1016/j.injury.2015.02.016. Epub 2015 Feb 26.

  PMID: 25840789 BACKGROUND

• Larsen P, Ceccotti AA, Elsoe R. High mortality following distal femur fractures: a cohort study including three hundred and two distal femur fractures. Int Orthop. 2020 Jan;44(1):173-177. doi: 10.1007/s00264-019-04343-9. Epub 2019 May 12.

  PMID: 31081515 BACKGROUND

• Boureau F, Benad K, Putman S, Dereudre G, Kern G, Chantelot C. Does primary total knee arthroplasty for acute knee joint fracture maintain autonomy in the elderly? A retrospective study of 21 cases. Orthop Traumatol Surg Res. 2015 Dec;101(8):947-51. doi: 10.1016/j.otsr.2015.09.021. Epub 2015 Nov 14.

  PMID: 26589193 BACKGROUND

• DeFrancesco CJ. CORR Insights(R): How Often Do Complications and Mortality Occur After Operatively Treated Periprosthetic Proximal and Distal Femoral Fractures? A Register-based Study. Clin Orthop Relat Res. 2023 Oct 1;481(10):1950-1953. doi: 10.1097/CORR.0000000000002686. Epub 2023 May 2. No abstract available.

  PMID: 37133402 DERIVED

MeSH Terms

Conditions

Femoral Fractures, Distal

Interventions

Open Fracture Reduction; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Amir Khoshbin, MD

  St Michael's Hospital - Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Jesse Wolfstadt, MD

  Mount Sinai Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassandra Tardif-Theriault, BKin

CONTACT

+1416-864-6060; cassandra.tardif-theriault@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, randomized controlled trial comparing acute distal femoral replacement versus surgical fixation as a treatment for geriatric comminuted bi-condylar distal femur fractures

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: September 3, 2019
• Study Start: October 1, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)