NCT04691466

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2013

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

12 years

First QC Date

December 27, 2020

Last Update Submit

December 30, 2020

Conditions

Osteoarthritis, KneeOsteoarthritis, Hip

Keywords

ReplacementArthroplastyPatient-relevant outcome measure (PROM)KOOSHOOS

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Assessment of the quality of life. Score change over time

    12 months

  • Pain intensity. Change over time

    12 months

  • Hip abductors muscle strength. Change over time

    12 months

  • Range of motion.

    12 months

Other Outcomes (2)

  • Body mass index (BMI)

    12 months

  • Activity

    12 months

Study Arms (2)

HIP_R

Patients undergoing hip replacement surgery

Procedure: Joint replacement

KNEE_R

Patients undergoing knee replacement surgery

Procedure: Joint replacement

Interventions

Joint replacementPROCEDURE

Routinely performed hip- or knee replacement

Also known as: Joint arthroplasty
HIP_RKNEE_R

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult population with osteoarthritis of the hip or knee.

You may qualify if:

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

You may not qualify if:

  • An inability to understand the Polish language,
  • Presence of neuromuscular disease and cognitive impairment,
  • Having a prosthesis in another joint of the ipsilateral or contralateral lower limb placed within 6 months before the current surgery,
  • Having rheumatoid arthritis,
  • Symptoms in several joints (hip, knee or ankle) with expected total joint arthroplasty within 1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bydgoszcz, PL-85-067, Poland

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis, Hip

Interventions

Arthroplasty, ReplacementArthroplasty

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Central Study Contacts

Przemysław T Paradowski, MD, PhD

CONTACT

+48575908432P.Paradowski@cm.umk.pl

Marek K Gojło, MD, PhD

CONTACT

+48503084950marekgojlo@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

December 27, 2020

First Posted

December 31, 2020

Study Start

January 2, 2013

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

December 31, 2020

Record last verified: 2020-12

Locations

PL(1)