Study Evaluating the Efficacy of Joint Replacement

Recruiting

• Conditions: Osteoarthritis, Hip; Osteoarthritis, Knee
• Interventions: Procedure: Joint replacement

• Registration Number: NCT04691466
• Lead Sponsor: Nicolaus Copernicus University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-02
• Status Verified: 2020-12
• Study First Submitted: 2020-12-27
• Study First Submitted QC: 2020-12-30
• Last Update Submitted: 2020-12-30
• Study First Posted: 2020-12-31
• Last Update Posted: 2020-12-31
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIP_R	Joint replacement	Patients undergoing hip replacement surgery
KNEE_R	Joint replacement	Patients undergoing knee replacement surgery

Primary Outcome Measures

Name	Time	Method
Assessment of the patients' opinion about their knee. Score change over time	12 months	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.
Assessment of the patients' opinion about their hip. Change over time	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Pain intensity. Change over time	12 months	Measured with the Visual Analog Scale (VAS); 0-10 points, worst to best.
Range of motion.	12 months	Assessment of range of motion in hips and knees, respectively, in following assessments; degrees.
Assessment of the quality of life. Score change over time	12 months	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.
Hip abductors muscle strength. Change over time	12 months	Determination of the Trendelenburg's sign in patients undergoing total hip replacement in following assessments; positive or negative.

Trial Locations

Locations (1)

Ludwik Rydygier Collegium Medicum, Faculty of Health Sciences, Jagiellońska 13/15; 🇵🇱 Bydgoszcz, Poland