Study Evaluating the Efficacy of Joint Replacement

Osteoarthritis, Knee Clinical Trial

— SEVERE  

Official title:

Assessment of Clinical Outcome Following Total Hip and Knee Replacement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04691466
• Other study ID #: WN758
• Status: Recruiting
• Start date: January 2, 2013
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2020
• Source: Nicolaus Copernicus University
• Contact: Przemyslaw T Paradowski, MD, PhD
• Phone: +48575908432
• Email: P.Paradowski[@]cm.umk.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patient-related outcomes were originally designed to measure outcomes in clinical studies. They were not developed to predict outcomes, however, different studies showed close association between values achieved preoperatively and postoperative outcomes. The aim of the present trial is to identify patients with satisfactory and unsatisfactory outcomes after joint replacement and to investigate whether there are any potential predicting potential in preoperative results of the patient-related outcomes and if there exist other predicting factors for functional recovery or treatment failure after joint replacement surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients with primary or secondary hip- and knee osteoarthritis undergoing joint replacement surgery.

Exclusion Criteria:

1. An inability to understand the Polish language,

2. Presence of neuromuscular disease and cognitive impairment,

3. Having a prosthesis in another joint of the ipsilateral or contralateral lower limb placed within 6 months before the current surgery,

4. Having rheumatoid arthritis,

5. Symptoms in several joints (hip, knee or ankle) with expected total joint arthroplasty within 1 year.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Procedure:
• Joint replacement
Routinely performed hip- or knee replacement

Locations

Country	Name	City	State
Poland	Ludwik Rydygier Collegium Medicum, Faculty of Health Sciences, Jagiellonska 13/15	Bydgoszcz

Sponsors (2)

Lead Sponsor	Collaborator
Nicolaus Copernicus University	Warmia and Mazury Oncology Centre

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body mass index (BMI)	Measurement of weight in kilograms and height in meters to combined to report BMI in kg/m^2; to be measured twice, before intervention and after 12 months.	12 months
Other	Activity	Measured with the Tegner Activity Score (TAS); 1-10 points, worst to best; to be measured twice, before intervention and after 12 months.	12 months
Primary	Assessment of the patients' opinion about their hip. Change over time	Change between the following assessments as measured with the Hip disability and Osteoarthritis Outcome Score (HOOS) in patients undergoing total hip replacement; 0-100 points, worst to best; minimal clinical difference (MCD) = 10 points.	12 months
Primary	Assessment of the patients' opinion about their knee. Score change over time	Change between the following assessments as measured with the Knee injury and Osteoarthritis Outcome Score (KOOS) in patients undergoing total knee replacement; 0-100 points, worst to best; minimal clinical difference (MCD) = 10 points.	12 months
Secondary	Assessment of the quality of life. Score change over time	Results of the generic PROM, the Short Form Health Survey-36 (SF-36) in both, patients undergoing hip and knee replacement; 0-100 points, worst to best.	12 months
Secondary	Pain intensity. Change over time	Measured with the Visual Analog Scale (VAS); 0-10 points, worst to best.	12 months
Secondary	Hip abductors muscle strength. Change over time	Determination of the Trendelenburg's sign in patients undergoing total hip replacement in following assessments; positive or negative.	12 months
Secondary	Range of motion.	Assessment of range of motion in hips and knees, respectively, in following assessments; degrees.	12 months