Clinical Trials Directory

Trials / Completed

CompletedNCT03868085

The Natural History of Injury-Related Disuse Osteopenia

Status
Completed
Phase
Study type
Observational
Enrollment
51 (actual)
Sponsor
Milton S. Hershey Medical Center · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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).

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTdual energy x-ray absorptiometryDXA scan

Timeline

Start date
2017-05-31
Primary completion
2020-11-04
Completion
2020-12-10
First posted
2019-03-08
Last updated
2023-02-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03868085. Inclusion in this directory is not an endorsement.