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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06440863
Other study ID # Y7MQG7gO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date May 1, 2024

Study information

Verified date June 2024
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 459
Est. completion date May 1, 2024
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Total Knee Arthroplasty
Patients undergoing total knee arthroplasty
Total Hip arthroplasty
Patients undergoing total hip arthroplasty

Locations

Country Name City State
Turkey Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine Istanbul Fatih

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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