Clinical trial NCT02475941: Early Weight Bearing on Supracondylar Distal Femur Fractures in Elderly Patients
Official title: Early Weight Bearing on Supracondylar Distal Femur Fractures in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Femur Fractures
Keywords: geriatric fractures
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 50
Sex: ALL
Minimum age (years): 64
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will be looking at geriatric distal femur fractures. The investigators will prospectively enroll these patients and allow patients to either weight bear as tolerated or limit their weight bearing post operatively. The investigators will evaluate functional outcomes.

Detailed description: Supracondylar femur fractures represent 4-7% of femur fractures. These are a common orthopaedic injury with an overall incidence of 37 per 100,000 person-years. These fractures are complex and challenging for orthopaedic surgeons. The fracture needs to be correctly reduced and, like nearly all fractures, fixed with enough stability to permit early joint motion. This allows for earlier patient rehabilitation, which can improve outcomes. There are a number of different fixation devices. Fixed angle implants such as retrograde intramedullary nails, angled blade plates, and 95-degree side plates have had good clinical outcomes with resistance to varus collapse. Recently, locking plates have become the standard method for distal femoral fracture fixation. Hendersen et al. provided a systematic review of locking plate fixation and demonstrated the range of complications as 0% to 32% and implant failure occurring late with 75% of failures occurring after 3 months and 50% occurring after 6 months. Ricci et al. sought to determine risk factors associated with failure of locked plate fixation of distal femur fractures and found that 19% required reoperation. The risk factors for reoperation found in this study were diabetes, smoking, increased body mass index, shorter plate length and open fracture. Most factors are out of surgeon control but are important to evaluate when considering prognosis.

After the fracture has been open reduced and internally fixed, there is debate on postoperative management of weight bearing. Weight bearing following fixation is generally restricted for 6 to 12 weeks until radiologic evidence of evidence demonstrates sufficient callous. This restricted weight bearing is primarily due to concerns of implant failure and loss of reduction. A study by Brumback et al. examined intramedullary nail fixation of distal femur fractures and concluded to allow full weight bearing of comminuted femoral shaft fractures with antegrade intramedullary nail. This study led surgeons to accelerate their rehabilitation protocols.

The post-operative weight bearing recommendations for distal femur fractures treated with locking plate vary widely which motivated Granata et al. to evaluate the biomechanics of immediate weight bearing of distal femur fractures treated with locked plate fixation. They found that the fatigue limit of the locked plate constructs was 1.9 times body weight for an average 70-kilogram patient over a simulated 10-week postoperative course. Although this study could not fully support immediate weight bearing due to the fact that femoral loads during gait have been estimated to be around 2 times body weight, it demonstrated adequate hardware fixation with weight bearing.

The benefits of early weight bearing are accelerated functional recovery, increased independence, decreased impact on the family, increased psychological benefits, reduced use of healthcare resources, decreased need for family intervention, and family to take care of the patient. The downside is the strength of fixation, the risk of implant failure, and the risk of loss of reduction. The goals are to evaluate the fracture, the complication rate, the mortality rate, and the risks of healthcare resources that have been used.

Eligibility criteria: Inclusion Criteria:

* Distal femur fractures, including periprosthetic fractures
* AO/OTA classification 33
* Above 64 years of age and below 90 years of age
* Household ambulators: defined as an individual who can walk continuously for distances that are considered reasonable for walking inside the home but limited for walking in the community due of endurance, strength, or safety concerns

Exclusion Criteria:

* Those who do not fit the inclusion criteria
* Concomitant ipsilateral lower extremity injury
* Contralateral lower extremity injury.
* Vascular injury of concomitant lower extremity requiring repair
* Pathologic fracture
* Definitive treatment delay of more than 2 weeks from initial injury
* Unable to comply with post-operative rehabilitation protocols or instructions
* Current or impending incarceration

Primary outcomes:
measure: Fracture Healing in Early Weight Bearing assessed by radiographs
timeFrame: Post op-3 months
Secondary outcomes:
measure: Visual Analog Scale to assess pain
timeFrame: Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury
measure: Oxford Knee Score to measure knee function
timeFrame: Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury
measure: SF12 to measure return to function
timeFrame: Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Wellstar
state: Georgia
city: Saint Louis
country: United States
facility: St. Louis Medical Center
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Greenville
country: United States
facility: Grennville Health Sysytems
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: St. Louis University
name: Howard Place, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nieves JW, Bilezikian JP, Lane JM, Einhorn TA, Wang Y, Steinbuch M, Cosman F. Fragility fractures of the hip and femur: incidence and patient characteristics. Osteoporos Int. 2010 Mar;21(3):399-408. doi: 10.1007/s00198-009-0962-6. Epub 2009 May 30.
citation: Zlowodzki M, Bhandari M, Marek DJ, Cole PA, Kregor PJ. Operative treatment of acute distal femur fractures: systematic review of 2 comparative studies and 45 case series (1989 to 2005). J Orthop Trauma. 2006 May;20(5):366-71. doi: 10.1097/00005131-200605000-00013.
citation: David SM, Harrow ME, Peindl RD, Frick SL, Kellam JF. Comparative biomechanical analysis of supracondylar femur fracture fixation: locked intramedullary nail versus 95-degree angled plate. J Orthop Trauma. 1997 Jul;11(5):344-50. doi: 10.1097/00005131-199707000-00008.
citation: Christodoulou A, Terzidis I, Ploumis A, Metsovitis S, Koukoulidis A, Toptsis C. Supracondylar femoral fractures in elderly patients treated with the dynamic condylar screw and the retrograde intramedullary nail: a comparative study of the two methods. Arch Orthop Trauma Surg. 2005 Mar;125(2):73-9. doi: 10.1007/s00402-004-0771-5. Epub 2004 Dec 21.
citation: Hartin NL, Harris I, Hazratwala K. Retrograde nailing versus fixed-angle blade plating for supracondylar femoral fractures: a randomized controlled trial. ANZ J Surg. 2006 May;76(5):290-4. doi: 10.1111/j.1445-2197.2006.03714.x.
citation: Ricci WM, Streubel PN, Morshed S, Collinge CA, Nork SE, Gardner MJ. Risk factors for failure of locked plate fixation of distal femur fractures: an analysis of 335 cases. J Orthop Trauma. 2014 Feb;28(2):83-9. doi: 10.1097/BOT.0b013e31829e6dd0.
citation: Henderson CE, Kuhl LL, Fitzpatrick DC, Marsh JL. Locking plates for distal femur fractures: is there a problem with fracture healing? J Orthop Trauma. 2011 Feb;25 Suppl 1:S8-14. doi: 10.1097/BOT.0b013e3182070127.
citation: Forster MC, Komarsamy B, Davison JN. Distal femoral fractures: a review of fixation methods. Injury. 2006 Feb;37(2):97-108. doi: 10.1016/j.injury.2005.02.015. Epub 2005 Apr 25.
citation: Kregor PJ, Stannard JA, Zlowodzki M, Cole PA. Treatment of distal femur fractures using the less invasive stabilization system: surgical experience and early clinical results in 103 fractures. J Orthop Trauma. 2004 Sep;18(8):509-20. doi: 10.1097/00005131-200409000-00006.
citation: Markmiller M, Konrad G, Sudkamp N. Femur-LISS and distal femoral nail for fixation of distal femoral fractures: are there differences in outcome and complications? Clin Orthop Relat Res. 2004 Sep;(426):252-7. doi: 10.1097/01.blo.0000141935.86481.ba.
citation: Brumback RJ, Toal TR Jr, Murphy-Zane MS, Novak VP, Belkoff SM. Immediate weight-bearing after treatment of a comminuted fracture of the femoral shaft with a statically locked intramedullary nail. J Bone Joint Surg Am. 1999 Nov;81(11):1538-44. doi: 10.2106/00004623-199911000-00005.
citation: Granata JD, Litsky AS, Lustenberger DP, Probe RA, Ellis TJ. Immediate weight bearing of comminuted supracondylar femur fractures using locked plate fixation. Orthopedics. 2012 Aug 1;35(8):e1210-3. doi: 10.3928/01477447-20120725-21.
citation: McGraw P, Kumar A. Periprosthetic fractures of the femur after total knee arthroplasty. J Orthop Traumatol. 2010 Sep;11(3):135-41. doi: 10.1007/s10195-010-0099-6. Epub 2010 Jul 27.
citation: Weinstein AM, Rome BN, Reichmann WM, Collins JE, Burbine SA, Thornhill TS, Wright J, Katz JN, Losina E. Estimating the burden of total knee replacement in the United States. J Bone Joint Surg Am. 2013 Mar 6;95(5):385-92. doi: 10.2106/JBJS.L.00206.