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OpenTrials
Completed

NCT Number: NCT03868085

The Natural History of Injury-Related Disuse Osteopenia

Determine the severity and time course (natural history) of disuse osteopenia that occurs in the lower extremity(ies) and lumbar spine of patients sustaining lower extremity injuries that require the patient to maintain restricted weight bearing status (12 weeks) following the surgical fixation of the patient's injuries.

The investigators hypothesize that there will be a significant decrease in the bone mineral density in the lower limbs of patients undergoing restricted weight bearing for peri-articular injuries of the lower extremity. This loss of bone mineral density is often prolonged in its duration and may lower subsequent fracture threshold and prolong the time to recovery and return to activities.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

It is well documented that restricted weight bearing even for relatively short periods (12 weeks) associated with the surgical treatment of peri-articular injuries of the lower extremity (ie acetabulum, distal femur, tibial plateau, pilon, talus, calcaneus) can lead to a measurable decrease in bone density in the injured limb. Furthermore, this osteopenia can persist for extended periods of time - much longer than the original period of restricted weight bearing. This relative osteopenia can delay recovery from injury, lower fracture threshold for subsequent injury and potentially delay return to active duty in the case of a wounded warrior. There exists a significant body of research in the modulation of the osteopenia associated with restricted weight bearing as it pertains to long term space flight (microgravity).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-70 at time of injury
  • Previously normal community ambulator (without ambulatory aid) prior to injury

Exclusion criteria

  • Presence of a total or hemi hip prosthesis in the injured extremity
  • Presence of lumbar fusion L1-L4
  • Previous ipsilateral lower extremity trauma
  • History of medical treatment for known osteoporosis (Calcium and Vitamin D supplementation alone is NOT an exclusion criteria)
  • Ambulatory dysfunction prior to injury
  • Inability to cooperate with DXA scanning
  • Head injury on admission requiring invasive monitoring or treatment
  • Inability to adhere to weight bearing restrictions
  • Inability to provide consent
  • Non English speaking
  • Pregnancy

Treatment and study plan

Dual Energy X-ray Absorptiometry

Diagnostic Test

DXA scan

Primary outcomes

  1. Determine the natural history of disuse osteopenia following restricted weight bearing from a lower extremity articular injury

    Time frame: 36 months

    Hip bone mineral density (DXA) of control and injured limb will be measured following weight bearing restrictions as part of treatment of lower limb articular injury and again following resumption of weight bearing after healing of the injury.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2019
Registry last updated
Feb 28, 2023

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.

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