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Study Evaluating the Efficacy of Joint Replacement

NCT ID: NCT04691466

Last Updated: 2020-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-02

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Osteoarthritis, Knee Osteoarthritis, Hip

Keywords

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Replacement Arthroplasty Patient-relevant outcome measure (PROM) KOOS HOOS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIP_R

Patients undergoing hip replacement surgery

Joint replacement

Intervention Type PROCEDURE

Routinely performed hip- or knee replacement

KNEE_R

Patients undergoing knee replacement surgery

Joint replacement

Intervention Type PROCEDURE

Routinely performed hip- or knee replacement

Interventions

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Joint replacement

Routinely performed hip- or knee replacement

Intervention Type PROCEDURE

Other Intervention Names

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Joint arthroplasty

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Warmia and Mazury Oncology Centre

UNKNOWN

Sponsor Role collaborator

Nicolaus Copernicus University

OTHER

Sponsor Role lead

Responsible Party

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Przemyslaw Paradowski

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ludwik Rydygier Collegium Medicum, Faculty of Health Sciences, Jagiellońska 13/15

Bydgoszcz, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Przemysław T Paradowski, MD, PhD

Role: CONTACT

Phone: +48575908432

Email: [email protected]

Marek K Gojło, MD, PhD

Role: CONTACT

Phone: +48503084950

Email: [email protected]

Facility Contacts

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Przemysław T Tomasz, MD, PhD

Role: primary

Marek K Gojło, MD, PhD

Role: backup

Other Identifiers

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WN758

Identifier Type: -

Identifier Source: org_study_id