Actively Recruiting
The Impact of a Surgeon-Initiated Bone Health Referral Pathway on Implant-Related Complications in Patients With Osteoporosis Undergoing Lower Extremity Arthroplasty
Led by Johns Hopkins University · Updated on 2025-10-14
2000
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of a surgeon-driven bone health referral pathway compared to the standard care referral by primary care providers in patients undergoing lower extremity arthroplasty with osteoporosis. The study aims to determine how this new referral approach affects implant-related complications and fragility fractures following surgery. This clinical trial is randomized and focuses on patients diagnosed with osteoporosis by preoperative DEXA scans. Patients in the treatment group will be formally referred by their surgeon to endocrinology for bone health clearance before surgery. Additional bone health labs are initiated, and endocrinology providers may conduct virtual consultations to review results, start appropriate medication, and educate patients. The control group receives standard care, where patients are informed of their osteoporosis and advised to follow up with their primary care provider without needing clearance before surgery. This study compares these two pathways over a period of at least five years. Participants will follow routine postoperative visits with their surgeons for up to two years post-surgery. Researchers will collect data on implant-related complications documented in surgical notes and monitor fragility fractures. The study uses an intention-to-treat approach, including patients who decline endocrinology consultation or treatment. No additional study-specific visits are required beyond normal care, and if the study ends early, patients should continue their assigned treatments if applicable.
CONDITIONS
Brief Title
Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Diagnosis of osteoporosis confirmed by DEXA scan
You will not qualify if you...
- Prior diagnosis of osteoporosis
- Prior treatment for osteoporosis
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for preoperative DEXA scan and labs
Duration - Up to the day of lower extremity arthroplasty
Participants are assigned to either the endocrinology bone health referral pathway with additional bone health evaluation and treatment initiation before surgery, or to the standard of care pathway with routine preoperative labs and no mandatory clearance before surgery.
1 referral visit with endocrinology (for those in the referral pathway) plus standard preoperative visits
Duration - Up to 2 years postoperatively
Participants undergo routine post-operative visits with their surgeon for up to 2 years to monitor implant-related outcomes. No study-specific visits occur during this period.
Routine surgical follow-up visits as per standard care
Trial Site Locations
Total: 1 location
1
Charter Professional Center
Columbia, Maryland, United States, 21044
Actively Recruiting
Research Team
S
Savyasachi C Thakkar, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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