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Early Weight Bearing on Supracondylar Distal Femur Fractures in Elderly Patients

Primary Purpose

Distal Femur Fractures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non Weight bearing
Early Weight Bearing
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Femur Fractures focused on measuring geriatric fractures

Eligibility Criteria

64 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wellstar
  • St. Louis Medical Center
  • Duke University
  • Wake Forest University
  • Grennville Health Sysytems
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early Weight Bearing

Non Weight Bearing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual Analog Scale to assess pain
Assess pain to compare between two groups
Oxford Knee Score to measure knee function
Validated outcome measure to document knee function to compare between two groups
SF12 to measure return to function
Measures patients outcome based on their return to function.

Full Information

First Posted
June 4, 2015
Last Updated
November 12, 2019
Sponsor
St. Louis University
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1. Study Identification

Unique Protocol Identification Number
NCT02475941
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 11, 2016 (Actual)
Primary Completion Date
January 2, 2019 (Actual)
Study Completion Date
September 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Femur Fractures
Keywords
geriatric fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Weight Bearing
Arm Type
Experimental
Arm Description
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.
Arm Title
Non Weight Bearing
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Non Weight bearing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Early Weight Bearing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fracture Healing in Early Weight Bearing assessed by radiographs
Description
Will assess radiographs to assess for a healed fracture with no loss of fixation or need for secondary surgery
Time Frame
Post op-3 months
Secondary Outcome Measure Information:
Title
Visual Analog Scale to assess pain
Description
Assess pain to compare between two groups
Time Frame
Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury
Title
Oxford Knee Score to measure knee function
Description
Validated outcome measure to document knee function to compare between two groups
Time Frame
Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury
Title
SF12 to measure return to function
Description
Measures patients outcome based on their return to function.
Time Frame
Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
64 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Place, MD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wellstar
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
St. Louis Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Grennville Health Sysytems
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29604
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19484169
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.
Results Reference
result
PubMed Identifier
16766943
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.
Results Reference
result
PubMed Identifier
9294798
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.
Results Reference
result
PubMed Identifier
15611863
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.
Results Reference
result
PubMed Identifier
16768683
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.
Results Reference
result
PubMed Identifier
23760176
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.
Results Reference
result
PubMed Identifier
21248560
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.
Results Reference
result
PubMed Identifier
16439229
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.
Results Reference
result
PubMed Identifier
15475846
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.
Results Reference
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PubMed Identifier
15346082
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.
Results Reference
result
PubMed Identifier
10565645
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.
Results Reference
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PubMed Identifier
22868607
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.
Results Reference
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PubMed Identifier
20661762
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.
Results Reference
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PubMed Identifier
23344005
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.
Results Reference
result

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Early Weight Bearing on Supracondylar Distal Femur Fractures in Elderly Patients

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