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

NCT05845021 | Recruiting

• 1 other identifier: IRB00386940
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis; Arthroplasty Complications; Fragility Fracture

Outcome Measures

Primary Outcomes (2)

• Incidence of All-Cause Revision following Lower Extremity Arthroplasty

  2-year incidence of all-cause revision following lower extremity arthroplasty

  2-years postoperatively

• Incidence of Fragility Fracture following Lower Extremity Arthroplasty

  2-year incidence of a fragility fracture in any location following lower extremity arthroplasty

  2-years postoperatively

Secondary Outcomes (3)

• Incidence of Aseptic Loosening following Lower Extremity Arthroplasty

  2-years postoperatively

• Incidence of Periprosthetic Fracture following Lower Extremity Arthroplasty

  2-years postoperatively

• Incidence of Periprosthetic Joint Infection following Lower Extremity Arthroplasty

  2-years postoperatively

Study Arms (2)

Surgeon-Initiated Bone Health Referral Pathway

EXPERIMENTAL

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.

Combination Product: Surgeon-Initiated Bone Health Referral Pathway

Standard of Care

NO INTERVENTION

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.

Interventions

Surgeon-Initiated Bone Health Referral Pathway COMBINATION_PRODUCT

Described in arm description

Surgeon-Initiated Bone Health Referral Pathway

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>50
• DEXA-confirmed diagnosis of osteoporosis

You may not qualify if:

• Prior diagnosis of osteoporosis
• Prior treatment for osteoporosis

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Charter Professional Center

Columbia, Maryland, 21044, United States

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Savyasachi Thakkar, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Savyasachi C Thakkar, MD

CONTACT

443-997-2663; sthakka2@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: September 27, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)