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

ConditionsOsteoporosisArthroplasty ComplicationsFragility Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

>50

DEXA-confirmed diagnosis of osteoporosis

Disqualifiers

Prior diagnosis of osteoporosis

Prior treatment for osteoporosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Surgeon-Initiated Bone Health Referral Pathway

    Combination product

    Described in arm description

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Surgeon-Initiated Bone Health Referral PathwayExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of All-Cause Revision following Lower Extremity Arthroplasty

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

Time frame
2-years postoperatively
2

Incidence of Fragility Fracture following Lower Extremity Arthroplasty

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

Time frame
2-years postoperatively

Secondary outcomes

1

Incidence of Aseptic Loosening following Lower Extremity Arthroplasty

2-year incidence of aseptic loosening indicated revision following lower extremity arthroplasty

Time frame
2-years postoperatively
2

Incidence of Periprosthetic Fracture following Lower Extremity Arthroplasty

2-year incidence of periprosthetic fracture indicated revision following lower extremity arthroplasty

Time frame
2-years postoperatively
3

Incidence of Periprosthetic Joint Infection following Lower Extremity Arthroplasty

2-year incidence of periprosthetic joint infection indicated revision following lower extremity arthroplasty

Time frame
2-years postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Source ClinicalTrials.gov
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