Study Evaluating the Efficacy of Joint Replacement (SEVERE)

Assessment of Clinical Outcome Following Total Hip and Knee Replacement

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip
• Intervention / Treatment: Procedure: Joint replacement

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Przemysław T Paradowski, MD, PhD; Phone Number: +48575908432; Email: P.Paradowski@cm.umk.pl
• Study Contact Backup: Name: Marek K Gojło, MD, PhD; Phone Number: +48503084950; Email: marekgojlo@gmail.com

Study Locations

• Poland
  • Bydgoszcz, Poland, PL-85-067
    • Recruiting
    • Ludwik Rydygier Collegium Medicum, Faculty of Health Sciences, Jagiellońska 13/15
    • Contact: Marek K Gojło, MD, PhD; Phone Number: +48503084950; Email: marekgojlo@gmail.com
    • Contact: Przemysław T Tomasz, MD, PhD; Phone Number: +48575908432; Email: P.Paradowski@cm.umk.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult population with osteoarthritis of the hip or knee.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIP_R; Patients undergoing hip replacement surgery	Procedure: Joint replacement; Routinely performed hip- or knee replacement; Other Names: Joint arthroplasty
KNEE_R; Patients undergoing knee replacement surgery	Procedure: Joint replacement; Routinely performed hip- or knee replacement; Other Names: Joint arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pain intensity. Change over time	Measured with the Visual Analog Scale (VAS); 0-10 points, worst to best.	12 months
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
Range of motion.	Assessment of range of motion in hips and knees, respectively, in following assessments; degrees.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Nicolaus Copernicus University
• Collaborators: Warmia and Mazury Oncology Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2013
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: December 27, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Arthroplasty; Replacement; KOOS; HOOS; Patient-relevant outcome measure (PROM)
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
• Other Study ID Numbers: WN758

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No