Early Weight Bearing on Supracondylar Distal Femur Fractures in Elderly Patients

NCT02475941 | Completed DMC

• 1 other identifier: 24664
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

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.

Conditions

Distal Femur Fractures

Keywords

geriatric fractures

Outcome Measures

Primary Outcomes (1)

• Fracture Healing in Early Weight Bearing assessed by radiographs

  Will assess radiographs to assess for a healed fracture with no loss of fixation or need for secondary surgery

  Post op-3 months

Secondary Outcomes (3)

• Visual Analog Scale to assess pain

  Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury

• Oxford Knee Score to measure knee function

  Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury

• SF12 to measure return to function

  Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury

Study Arms (2)

Early Weight Bearing

EXPERIMENTAL

Surgeon based prospective cohort supported in the literature to answer research questions in which surgeons have a preferred treatment type. Early weight bearing are those who are permitted in the post operative instructions to be Weight Bear as tolerated after fracture fixation.

Other: Early Weight Bearing

Non Weight Bearing

ACTIVE COMPARATOR

Surgeon based prospective cohort supported in the literature to answer research questions in which surgeons have a preferred treatment type. Non weight bearing are those who are NOT permitted in the post operative instructions to be Weight Bear after fracture fixation.

Other: Non Weight bearing

Interventions

Non Weight bearing OTHER

The design will be a surgeon based prospective cohort supported in the literature to answer research questions in which surgeons may have a preferred treatment type. Each surgeon will treat study subjects by his or her single chosen method (weight bearing as tolerated post operatively versus non 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.

Non Weight Bearing

Early Weight Bearing OTHER

The design will be a surgeon based prospective cohort supported in the literature to answer research questions in which surgeons may have a preferred treatment type. Each surgeon will treat study subjects by his or her single chosen method (weight bearing as tolerated post operatively versus non 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.

Early Weight Bearing

Eligibility Criteria

• Age: 64 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (6)

Wellstar

Atlanta, Georgia, 30312, United States

Location

St. Louis Medical Center

St Louis, Missouri, 63110, United States

Location

Duke University

Durham, North Carolina, 27703, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Grennville Health Sysytems

Greenville, South Carolina, 29604, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (14)

• 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.

  PMID: 19484169 RESULT

• 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.

  PMID: 16766943 RESULT

• 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.

  PMID: 9294798 RESULT

• 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.

  PMID: 15611863 RESULT

• 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.

  PMID: 16768683 RESULT

• 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.

  PMID: 23760176 RESULT

• 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.

  PMID: 21248560 RESULT

• 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.

  PMID: 16439229 RESULT

• 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.

  PMID: 15475846 RESULT

• 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.

  PMID: 15346082 RESULT

• 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.

  PMID: 10565645 RESULT

• 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.

  PMID: 22868607 RESULT

• 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.

  PMID: 20661762 RESULT

• 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.

  PMID: 23344005 RESULT

MeSH Terms

Conditions

Femoral Fractures, Distal

Condition Hierarchy (Ancestors)

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

Study Officials

• Howard Place, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 19, 2015
• Study Start: May 11, 2016
• Primary Completion: January 2, 2019
• Study Completion: September 27, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

US (6)