NCT06440863

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
459

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

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, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

5 years

First QC Date

May 27, 2024

Last Update Submit

June 1, 2024

Conditions

Keywords

Total Hip ArthroplastyTotal Knee ArthroplastyWeight LossObesityBody Mass Index

Outcome Measures

Primary Outcomes (2)

  • BMI

    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

    It is scored between 0 and 48. 48 is the best function.

    2 years

Study Arms (2)

Total Knee Arthroplasty

ACTIVE COMPARATOR

Patients indicated for total knee arthroplasty.

Procedure: Total Knee Arthroplasty

Total Hip Arthroplasty

ACTIVE COMPARATOR

Patients indicated for total hip arthroplasty.

Procedure: Total Hip arthroplasty

Interventions

Patients undergoing total knee arthroplasty

Total Knee Arthroplasty

Patients undergoing total hip arthroplasty

Total Hip Arthroplasty

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine

Istanbul, Fatih, 34098, Turkey (Türkiye)

Location

Related Publications (3)

  • Woodruff MJ, Stone MH. Comparison of weight changes after total hip or knee arthroplasty. J Arthroplasty. 2001 Jan;16(1):22-4. doi: 10.1054/arth.2001.9826.

    PMID: 11172266BACKGROUND
  • Riddle DL, Singh JA, Harmsen WS, Schleck CD, Lewallen DG. Clinically important body weight gain following knee arthroplasty: a five-year comparative cohort study. Arthritis Care Res (Hoboken). 2013 May;65(5):669-77. doi: 10.1002/acr.21880.

    PMID: 23203539BACKGROUND
  • Inacio MC, Silverstein DK, Raman R, Macera CA, Nichols JF, Shaffer RA, Fithian D. Weight patterns before and after total joint arthroplasty and characteristics associated with weight change. Perm J. 2014 Winter;18(1):25-31. doi: 10.7812/TPP/13-082.

    PMID: 24626069BACKGROUND

MeSH Terms

Conditions

Joint DiseasesObesityWeight Loss

Interventions

Arthroplasty, Replacement, KneeArthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Cumhur Deniz Davulcu

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 27, 2024

First Posted

June 4, 2024

Study Start

January 1, 2018

Primary Completion

December 30, 2022

Study Completion

May 1, 2024

Last Updated

June 4, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations