DIFFIR - Geriatric Distal Femur Fixation Versus Replacement

Official title

DIFFIR: Geriatric Distal Femur Fixation Versus Replacement - A Randomized Controlled Trial of Acute Open Reduction Internal Fixation (ORIF) Versus Distal Femoral Replacement (DFR)

Overview

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.

Detailed description

The proposed study is a prospective, randomized controlled trial, involving multiple centers across North America, to compare distal femur replacement (knee prosthesis) versus surgical fixation as a treatment for geriatric distal femur fracture.

Patients 65 years of age and older, with closed, displaced ( when the two ends of the bone are not lined up straight), comminuted (bone is in many pieces) distal femur fracture, who meet the inclusion criteria and agree to participate in the study, will be randomly assigned (by chance like flipping a coin) to receive either acute distal femoral replacement or surgical fixation.

The hypothesis is that patients in the acute distal femoral replacement group will have superior function, range of motion (full movement potential of a joint), general health status, reduced pain, and lower complications when compared to patients in the surgical fixation group.

Interventions

• Procedure Distal femoral replacement
  The distal portion of the femur (up to two thirds) is excised and replaced by a endoprosthesis incorporating a hinged total knee replacement.
• Procedure Surgical Fixation (ORIF)
  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

Primary outcome measures

• Oxford Knee Score (OKS) [Time frame: 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 outcome measures (6)

• Daily morphine equivalent usage while in hospital [Time frame: 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) [Time frame: 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 [Time frame: Questionnaire will be completed by patients at 3, 6, 9, 12, and 24 months post-surgery]
• knee range of movement (ROM) [Time frame: Test will be completed at each follow up visit at 3, 6,12 and 24 months post surgery]
• Timed Up and Go (TUG) test [Time frame: Test will be completed at each follow up visit at 3, 6, 12 and 24 months post surgery]
• Knee Extension lag [Time frame: Test will be completed at each follow up visit at 3, 6,12 and 24 months post surgery]

Eligibility criteria

Inclusion criteria

• Male and female patients
• 65 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• St Michael's Hospital - Unity Health Toronto — Toronto

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT04076735 · 19-145

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗