The Natural History of Injury-Related Disuse Osteopenia

NCT ID: NCT03868085

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-31

Study Completion Date

2020-12-10

Brief Summary

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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

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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

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Osteopenia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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dual energy x-ray absorptiometry

DXA scan

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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J. Spence Reid

Professor and Chief, Division of Orthopaedic Trauma

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John S Reid, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

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Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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00006601

Identifier Type: -

Identifier Source: org_study_id

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