Clinical trial NCT03868085: The Natural History of Injury-Related Disuse Osteopenia
Official title: The Natural History of Injury-Related Disuse Osteopenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteopenia
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -Patients with one or more of the following lower extremity peri-articular fractures with restricted weight bearing for 12 weeks: (OTA types A,B,C). Injuries may be unilateral or bilateral.

1. Acetabulum fracture
2. Distal Femur fracture
3. Tibial plateau fracture
4. Pilon fracture
5. Talus fracture
6. Calcaneus fracture

Brief 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Determine the natural history of disuse osteopenia following restricted weight bearing from a lower extremity articular injury
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: John S Reid, MD
role: PRINCIPAL_INVESTIGATOR
References: