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Completed

NCT Number: NCT05623540

Bisphosphonates Use After Total Joint Arthroplasty

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.

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Key information

Conditions

Diphosphonates Fractures, Bone Periprosthetic Fractures Wounds and Injuries

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tri-Service General Hospital, National Defense Medical Center

Taipei, 11472, Taiwan

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Bisphosphonates, Combinations

Drug

Primary outcomes

  1. revision rate of joint arthroplasty

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

    revision rate of joint arthroplasty after primary surgery

Secondary outcomes

  1. The rate of secondary total joint arthroplasty

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

    The rate of secondary total joint arthroplasty

  2. The rate of periprosthetic joint infection

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

    The rate of periprosthetic joint infection

  3. The rate of periprosthetic fracture

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

    The rate of periprosthetic fracture

  4. Mortality rate

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

    Mortality rate

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Official study title

Postoperative Use of Bisphosphonates Reduces Adverse Outcome After Primary Total Joint Arthroplasty: A Nationwide Population-based Cohort Study

Important dates

Study start
2000
Primary completion
2015
Study completion
2022
First posted
Nov 21, 2022
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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