Bisphosphonates Use After Total Joint Arthroplasty

Completed

• Conditions: Diphosphonates
• Interventions: Drug: Bisphosphonates, Combinations

• Registration Number: NCT05623540
• Lead Sponsor: National Defense Medical Center, Taiwan

Brief Summary

Background Bisphosphonates has been associated with a decreased risk of revision total joint replacements because of its effects on decreased periprosthetic bone loss and prosthetic migration. However, the results in the early literature are inconsistent and the influence of bisphosphonates on associated complications and subsequent total joint arthroplasty (TJA) remains unknown. This study is to investigate the association between the use of bisphosphonates and risk of adverse outcomes after primary TJA.

Materials and Methods This matched cohort study utilized National Health Insurance Research Database in Taiwan to identify patients who underwent primary TJA over a 15-year period (January 2000- December 2015 inclusive). Study participants were further categorized into two groups: bisphosphonates users and nonusers, using propensity score matching. The Kaplan-Meier curve analysis and adjusted hazard ratios (aHR) of revision surgery, adverse outcomes of primary surgery and undergoing subsequent TJA were calculated using Cox regression analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01-01
• Primary Completion: 2015-12-31
• Status Verified: 2022-11
• Study Completion: 2022-11-02
• Study First Submitted: 2022-11-13
• Study First Submitted QC: 2022-11-18
• Last Update Submitted: 2022-11-20
• Study First Posted: 2022-11-21
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27405

Inclusion Criteria

1. Patients who underwent primary total joint arthroplasty during the study period (January 1, 2000 to December 31, 2015).

Exclusion Criteria

1. Patients with total joint arthroplasty before the index date,
2. Patients with existing pathologic fracture, nonunion of fracture and partial joint replacement,
3. Patients who were lost to follow-up
4. Patients < 40 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bisphosphonates users	Bisphosphonates, Combinations	Patients who underwent primary total joint arthroplasty with bisphosphonates use
bisphosphonates nonusers	Bisphosphonates, Combinations	Patients who underwent primary total joint arthroplasty without bisphosphonates use

Primary Outcome Measures

Name	Time	Method
revision rate of joint arthroplasty	a 15-year period (January 2000- December 2015 inclusive)	revision rate of joint arthroplasty after primary surgery

Secondary Outcome Measures

Name	Time	Method
The rate of secondary total joint arthroplasty	a 15-year period (January 2000- December 2015 inclusive)	The rate of secondary total joint arthroplasty
The rate of periprosthetic joint infection	a 15-year period (January 2000- December 2015 inclusive)	The rate of periprosthetic joint infection
The rate of periprosthetic fracture	a 15-year period (January 2000- December 2015 inclusive)	The rate of periprosthetic fracture
Mortality rate	a 15-year period (January 2000- December 2015 inclusive)	Mortality rate

Trial Locations

Locations (1)

Tri-Service General Hospital, National Defense Medical Center; 🇨🇳 Taipei, Taiwan