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Completed

NCT Number: NCT03167099

Immediate Weight Bearing Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures

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.

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Key information

Conditions

Closed Supracondylar Fracture of Femur

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University

Morgantown, West Virginia, 26506, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Full Weight Bearing

Procedure

full weight bearing after fixation of a distal femur fracture

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

Immediate Weight Bearing as Tolerated Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures; a Prospective, Randomized Study

Acronym: WtBrFemFx

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 25, 2017
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.