Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty

Part of paid clinical trials in Columbia, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05845021
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Surgeon-Initiated Bone Health Referral Pathway — COMBINATION_PRODUCT
    Described in arm description

Study Details

The goal of this clinical trial is to observe the impact of a surgeon-driven bone health referral pathway following lower extremity arthroplasty. The main question this study aims to answer is: 1\) What is impact of a surgeon-driven bone health referral pathway on implant-related complications and fragility fractures when compared to standard of care primary care provider referral. Researchers will compare the endocrinology referral pathway and standard of care to see if there is a difference in treatment rates, fragility fractures, and implant-related complications following lower extremity arthroplasty.

Key Dates

Start date
Sep 27, 2023
Status verified
Oct 2025
Primary completion
Oct 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Surgeon-Initiated Bone Health Referral Pathway
    Patients assigned in the endocrinology bone health referral pathway would be formally referred by the surgeon to see endocrinology for clearance before undergoing lower extremity arthroplasty. In addition to normal labs, the surgeon will initiate additional bone health labs in these patients before consultation with endocrinology. Endocrinology providers will be available for a virtual consultation to review the patients DEXA and bone health labs; start the patient on the appropriate medication; and provide patient education regarding osteoporosis and bone health. For those undergoing evaluation by endocrinology, these providers will let the surgical team know when and whether the patient has initiated treatment.
  • No Intervention: Standard of Care
    The control arm will be composed of patients identified in the osteoporotic range like the endocrinology bone health referral pathway. These patients will be told by the surgeon that the patient has osteoporosis based on the DEXA scan and will be told to follow-up these results with the patient's primary care provider. These patients do not need bone health clearance before undergoing surgery. Only serum 25-hydroxyvitamin D levels will be added on to the patient's standard of care pre-operative labs. The control arm is the current standard of care. Comparing this pathway to the endocrinology referral pathway permits an assessment on the efficacy of the new pathway.

Primary Outcome Measure

Incidence of All-Cause Revision following Lower Extremity Arthroplasty [ Time Frame: 2-years postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Charter Professional CenterColumbiaMaryland21044
Savya Thakkar

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By research site
Charter Professional Center· Columbia, MD

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