NCT05623540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27,405

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
16 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

16 years

First QC Date

November 13, 2022

Last Update Submit

November 20, 2022

Conditions

Diphosphonates

Keywords

BisphosphonatesTotal joint arthroplastyRevision surgeryPeriprosthetic fracture

Outcome Measures

Primary Outcomes (1)

  • revision rate of joint arthroplasty

    revision rate of joint arthroplasty after primary surgery

    a 15-year period (January 2000- December 2015 inclusive)

Secondary Outcomes (4)

  • The rate of secondary total joint arthroplasty

    a 15-year period (January 2000- December 2015 inclusive)

  • The rate of periprosthetic joint infection

    a 15-year period (January 2000- December 2015 inclusive)

  • The rate of periprosthetic fracture

    a 15-year period (January 2000- December 2015 inclusive)

  • Mortality rate

    a 15-year period (January 2000- December 2015 inclusive)

Study Arms (2)

bisphosphonates users

Patients who underwent primary total joint arthroplasty with bisphosphonates use

Drug: Bisphosphonates, Combinations

bisphosphonates nonusers

Patients who underwent primary total joint arthroplasty without bisphosphonates use

Drug: Bisphosphonates, Combinations

Interventions

Bisphosphonates, CombinationsDRUG
bisphosphonates nonusersbisphosphonates users

Eligibility Criteria

Age40 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) was used to identify diagnoses and related procedures. The target cohort in NHIRD were those who underwent primary total joint arthroplasty during the study period (January 1, 2000 to December 31, 2015).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-Service General Hospital, National Defense Medical Center

Taipei, 11472, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 38492035DERIVED

MeSH Terms

Conditions

Periprosthetic Fractures

Interventions

Diphosphonates

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, department of Orthopedics, school of Medicine

Study Record Dates

First Submitted

November 13, 2022

First Posted

November 21, 2022

Study Start

January 1, 2000

Primary Completion

December 31, 2015

Study Completion

November 2, 2022

Last Updated

November 22, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

There is no plans to make individual participant data (IPD) available to other researchers.

Locations

TW(1)