Clinical trial

The Impact of a Surgeon-Initiated Bone Health Referral Pathway on Implant-Related Complications in Patients With Osteoporosis Undergoing Lower Extremity Arthroplasty

Name

IRB00386940

Description

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.

Trial arms

Trial start

2023-09-27

Estimated PCD

2024-10-01

Trial end

2028-07-01

Status

Recruiting

Treatment

Surgeon-Initiated Bone Health Referral Pathway

Described in arm description

Arms:

Surgeon-Initiated Bone Health Referral Pathway

Size

2000

Primary endpoint

Incidence of All-Cause Revision following Lower Extremity Arthroplasty

2-years postoperatively

Incidence of Fragility Fracture following Lower Extremity Arthroplasty

2-years postoperatively

Eligibility criteria

Inclusion Criteria: * \>50 * DEXA-confirmed diagnosis of osteoporosis Exclusion Criteria: * Prior diagnosis of osteoporosis * Prior treatment for osteoporosis

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 2000, 'type': 'ESTIMATED'}}

Updated at

2023-11-09

1 organization

1 product

3 indications

Organization

Johns Hopkins University

Product

Surgeon-Initiated Bone Health Referral Pathway

Indication

Osteoporosis

Indication

Arthroplasty Complications

Indication

Fragility Fracture