The Natural History of Injury-Related Disuse Osteopenia

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03868085
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Anticipated Duration (Months): 67
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteopenia	Diagnostic Test: dual energy x-ray absorptiometry

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).

Study Design

• Study Type: Observational
• Actual Enrollment: 51 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Natural History of Injury-Related Disuse Osteopenia
• Actual Study Start Date: May 31, 2017
• Anticipated Primary Completion Date: May 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Milton S. Hershey Medical Center

Investigators

• Principal Investigator: John S Reid, MD, Milton S. Hershey Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: J. Spence Reid, Professor and Chief, Division of Orthopaedic Trauma, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT03868085
• Other Study ID Numbers: 00006601
• First Posted: Mar 8, 2019
• Last Update Posted: Aug 25, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bone Diseases, Metabolic

Study Results

No Results Posted as of Aug 25, 2021