NCT03411083

Brief Summary

In this cohort study, we will investigate short and long term outcomes after knee replacement surgery and identify preoperative and early postoperative factors associated with long term outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 19, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2021

Completed
Last Updated

February 21, 2025

Status Verified

May 1, 2020

Enrollment Period

3.1 years

First QC Date

January 19, 2018

Last Update Submit

February 20, 2025

Conditions

Arthroplasty, Replacement, Knee

Keywords

RehabilitationRecovery of functionOutcome Assessment (Health Care)Patient Reported outcome MeasuresTreatment OutcomePain, PostoperativePain ManagementOrthopedic Surgery

Outcome Measures

Primary Outcomes (1)

  • Oxford Knee Score (OKS) (continous)

    Disease specific Patient Reported Outcome Measure regarding function and pain. Each question is answered by ticking a box on a five-point Likert scale. Responses are then totalled to obtain a score between 0 and 48, with 48 being the best.

    52 weeks after surgery

Secondary Outcomes (25)

  • Oxford Knee Score (OKS) (continous)

    Pre surgery

  • Oxford Knee Score (OKS) (continous)

    12 weeks after surgery

  • EQ-5D-5L (continous)

    Pre surgery

  • EQ-5D-5L (continous)

    12 weeks after surgery

  • EQ-5D-5L (continous)

    52 weeks after surgery

  • +20 more secondary outcomes

Other Outcomes (4)

  • Pain Visual Analog Scale (VAS) (continous)

    2 weeks after surgery

  • Analgetic pain medication intake (type and frequence)

    2 weeks after surgery

  • Range of Motion (ROM) in passive knee flexion and passive knee extension (degrees)

    2 weeks after surgery

  • +1 more other outcomes

Study Arms (1)

Knee replacement

Patients assigned for total or unicompartmental knee replacement surgery

Procedure: Total or unicompartmental knee replacement

Interventions

Total or unicompartmental knee replacementPROCEDURE

Fast-track Knee replacement surgery including same day surgery

Knee replacement

Eligibility Criteria

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

Patients assigned for primary knee replacement in the period from February 2018 to May 2020 will be consecutively recruited to the cohort from Silkeborg Regional Hospital Denmark.

You may qualify if:

  • Assigned for primary Unicompartmental or Total Knee Replacement
  • Age ≥ 18 years at the time of recruitment
  • Able to read and understand Danish

You may not qualify if:

  • Not mentally able to reply to the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silkeborg Regional Hospital

Silkeborg, Jutland, 8600, Denmark

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Lone Ramer Mikkelsen, Msc., Ph.D.

    Interdisciplinary Research Unit Elective Surgery Centre Silkeborg Regional Hospital, Denmark

    PRINCIPAL INVESTIGATOR

  • Mette Garval, PT, Msc.

    Physical Therapy Department, Elective Surgery Centre Silkeborg Regional Hospital, Denmark

    PRINCIPAL INVESTIGATOR

  • Søren Thorgaard Skou, PT, PhD

    Research Unit for Musculoskeletal Function and Physiotherapy University of Southern Denmark

    STUDY CHAIR

  • Anne Mette Schmidt, Msc., Ph.D.

    Interdisciplinary Research Unit Elective Surgery Centre Silkeborg Regional Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

January 25, 2018

Study Start

February 1, 2018

Primary Completion

March 23, 2021

Study Completion

March 23, 2021

Last Updated

February 21, 2025

Record last verified: 2020-05

Locations

DK(1)