Postoperative BMI Changes and Functional Outcomes in Knee and Hip Arthroplasty

June 1, 2024 updated by: Mete Ozer, Istanbul University - Cerrahpasa (IUC)

The Effect of Changes in Body Mass Index After Total Knee and Hip Arthroplasty on Patient Functional Scores

PURPOSE Obesity poses challenges to preoperative mobility and functional recovery for arthroplasty patients, yet postoperative weight loss remains elusive. This study aims to investigate postoperative weight changes and their impact on functional scores following knee and hip arthroplasty, exploring factors influencing these changes.

METHODS A total of 459 knee and hip arthroplasty cases with a 2-year follow-up were analyzed. BMI and Oxford scores were tracked, alongside factors including comorbidities, corticosteroid use, physiotherapy, and unilateral vs. bilateral surgery.

EXPECTED OUTCOMES Based on the study's design and the data available, we anticipate observing the impact of changes in patients' BMI on clinical scores as an independent variable. Additionally, we aim to elucidate the effects of comorbidities, corticosteroid use, physiatrist follow-up, and the type of surgical procedure on both BMI and clinical outcomes. Through this analysis, we expect to gain a comprehensive understanding of how these factors interplay to influence postoperative recovery and overall patient health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

459

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34098
        • Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who underwent primary TKA and THA with a 2-year follow-up were included

Exclusion Criteria:

  • Patients who underwent bariatric surgery before or after the surgery
  • Incomplete 2-year follow-up
  • Whom BMI or Oxford scores could not be accessed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Total Knee Arthroplasty
Patients indicated for total knee arthroplasty.
Procedure: Total Knee Arthroplasty
Patients undergoing total knee arthroplasty
Active Comparator: Total Hip Arthroplasty
Patients indicated for total hip arthroplasty.
Procedure: Total Hip arthroplasty
Patients undergoing total hip arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: 2 years
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
2 years
Oxford hip and knee scores
Time Frame: 2 years
It is scored between 0 and 48. 48 is the best function.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Cumhur Deniz Davulcu, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

June 1, 2024

First Posted (Estimated)

June 4, 2024

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 1, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Y7MQG7gO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes All demographic data, clinical scores, and BMI measurement results will be shared.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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