Clinical trial NCT05623540: Bisphosphonates Use After Total Joint Arthroplasty
Official title: Postoperative Use of Bisphosphonates Reduces Adverse Outcome After Primary Total Joint Arthroplasty: A Nationwide Population-based Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diphosphonates
Keywords: Bisphosphonates
Total joint arthroplasty
Revision surgery
Periprosthetic fracture
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 27405
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: revision rate of joint arthroplasty
timeFrame: a 15-year period (January 2000- December 2015 inclusive)
Secondary outcomes:
measure: The rate of secondary total joint arthroplasty
timeFrame: a 15-year period (January 2000- December 2015 inclusive)
measure: The rate of periprosthetic joint infection
timeFrame: a 15-year period (January 2000- December 2015 inclusive)
measure: The rate of periprosthetic fracture
timeFrame: a 15-year period (January 2000- December 2015 inclusive)
measure: Mortality rate
timeFrame: a 15-year period (January 2000- December 2015 inclusive)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital, National Defense Medical Center
Study officials:
References: