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Immediate Weight Bearing Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures (WtBrFemFx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03167099
Recruitment Status : Completed
First Posted : May 25, 2017
Results First Posted : August 5, 2022
Last Update Posted : August 5, 2022
Sponsor:
Information provided by (Responsible Party):
David Hubbard, MD, West Virginia University

Brief Summary:
This study is designed to examine if immediate weight bearing on a distal femur fracture fixed with a primary locking plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), is safe and promotes more rapid fracture healing than partial weight bearing, which is standard of care.

Condition or disease Intervention/treatment Phase
Closed Supracondylar Fracture of Femur Procedure: Full Weight Bearing Not Applicable

Detailed Description:
This study is designed to examine if immediate weight bearing on a distal femur fracture fixed with a primary locking plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), is safe and promotes more rapid fracture healing than partial weight bearing, which is standard of care. Historically and currently patients are kept partial weight bearing after fixation of these fractures for 6-12 weeks until callous formation is observed on radiographs. The hypothesis is that participants allowed to bear weight immediately will heal at least as quickly as those who have weight bearing status protected with the added benefits from early mobilization. Fracture healing will be monitored closely by follow up appointments and complications will be documented.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Both investigators and participants are aware of the assignment. There is no masking; only randomization.
Primary Purpose: Treatment
Official Title: Immediate Weight Bearing as Tolerated Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures; a Prospective, Randomized Study
Actual Study Start Date : April 2015
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Full Weight Bearing
Participants assigned to full weight bearing after fixation of distal femur fracture.
Procedure: Full Weight Bearing
full weight bearing after fixation of a distal femur fracture

No Intervention: Partial Weight Bearing
Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.



Primary Outcome Measures :
  1. Time to Distal Femur Fracture Healing by Radiographic Evidence [ Time Frame: up to 12 weeks ]
    Radiographs were analyzed postoperatively to determine bridging of 3 or 4 cortices per standard of care during follow-up office visits.


Secondary Outcome Measures :
  1. Time to Ambulation [ Time Frame: up to 24 weeks ]
    Investigators measure time to ambulation

  2. Time of Participation in Physical Therapy [ Time Frame: up to 1 year ]
    Investigators measure the length of time of physical therapy participation


Other Outcome Measures:
  1. Number of Days to Discharge [ Time Frame: Up to 30 days ]
    Investigators record the number of days from surgery to discharge

  2. Discharge Disposition [ Time Frame: Up to 30 days ]
    Investigators record the participants' discharge location, e.g. home, rehabilitation facility

  3. Change in Pain [ Time Frame: 2 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months ]
    Investigators record the pain from 0-10 at each time point

  4. Change in Knee Society Score [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]
    Participants complete the Knee Society survey at the listed time points

  5. Knee Flexion [ Time Frame: 12 months ]
    Investigators measure knee flexion

  6. Number of Participants With Non Union [ Time Frame: 12 months ]
    Investigators assess non union at 1 year

  7. Number of Participants With Malunion [ Time Frame: 12 months ]
    Investigators assess malunion at 1 year

  8. Number of Participants With Infection [ Time Frame: 12 months ]
    Investigators check for infection

  9. Deep Vein Thrombosis at Each Time Point [ Time Frame: 12 months ]
    Investigators check for Deep Vein Thrombosis

  10. Number of Participants With Pulmonary Embolism [ Time Frame: 12 months ]
    Investigators check for Pulmonary Embolism

  11. Number of Participants With Implant Failure [ Time Frame: 12 months ]
    Investigators check for implant failure at 12 months

  12. Change in Vit D Level in Age 65 and Older [ Time Frame: baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months ]
    Investigators assess Vit D level in subject age 65 and older at all time points listed

  13. Study Mortality [ Time Frame: 12 months ]
    Investigators record any deaths at 12 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged > 18 yo
  • distal supracondylar femur fracture (Supracondylar distal femur fractures treated with a locked plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), including peri-prosthetic fractures)
  • both male and female

Exclusion Criteria:

  • Patients with an intracondylar split,
  • polytrauma patients with associated trauma that will inhibit their ability to weight bear,
  • metastatic disease,
  • incomplete follow up,
  • subjects with questionable ability to bear weight (ie advanced dementia),
  • open fractures with bone loss.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167099


Locations
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United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
Investigators
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Principal Investigator: David F Hubbard, MD West Virginia University
  Study Documents (Full-Text)

Documents provided by David Hubbard, MD, West Virginia University:
Informed Consent Form  [PDF] September 11, 2019

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Responsible Party: David Hubbard, MD, MD, Chief, Orthopaedic Trauma Service, Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT03167099    
Other Study ID Numbers: 1408401969A
First Posted: May 25, 2017    Key Record Dates
Results First Posted: August 5, 2022
Last Update Posted: August 5, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared with other researchers. Shared group data will be presented at Orthopaedic conferences and through manuscript submission.
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries