Bisphosphonates Use After Total Joint Arthroplasty

NCT ID: NCT05623540

Last Updated: 2022-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27405 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-01

Study Completion Date

2022-11-02

Brief Summary

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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

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Conditions

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Diphosphonates

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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bisphosphonates users

Patients who underwent primary total joint arthroplasty with bisphosphonates use

Bisphosphonates, Combinations

Intervention Type DRUG

bisphosphonates nonusers

Patients who underwent primary total joint arthroplasty without bisphosphonates use

Bisphosphonates, Combinations

Intervention Type DRUG

Interventions

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Bisphosphonates, Combinations

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Defense Medical Center, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Jen-Ta Shih

Lecturer, department of Orthopedics, school of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tri-Service General Hospital, National Defense Medical Center

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Shih JT, Tan TL, Shen PH, Yeh TT, Wu CC, Pan RY, Chien WC, Chung CH, Wang SH. Postoperative Bisphosphonates Use is Associated with Reduced Adverse Outcomes After Primary Total Joint Arthroplasty of Hip and Knee: A Nationwide Population-Based Cohort Study. Calcif Tissue Int. 2024 May;114(5):451-460. doi: 10.1007/s00223-024-01192-6. Epub 2024 Mar 16.

Reference Type DERIVED
PMID: 38492035 (View on PubMed)

Other Identifiers

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TSGH-D-110103

Identifier Type: -

Identifier Source: org_study_id

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