The Natural History of Injury-Related Disuse Osteopenia

NCT03868085 | Completed

• 1 other identifier: 00006601
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopenia

Outcome Measures

Primary Outcomes (1)

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

  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.

  36 months

Interventions

dual energy x-ray absorptiometry DIAGNOSTIC_TEST

DXA scan

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Presence of a total or hemi hip prosthesis in the injured extremity
• Presence of lumbar fusion L1-L4
• Previous ipsilateral lower extremity trauma
• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• John S Reid, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief, Division of Orthopaedic Trauma

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: March 8, 2019
• Study Start: May 31, 2017
• Primary Completion: November 4, 2020
• Study Completion: December 10, 2020
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)