NCT03233620

Brief Summary

The aim of our study was to assess the effectiveness of contemporary knee arthroplasty in working-age patients (\< 65 years) by conducting a prospective cohort study with 2-year follow up. Outcomes were measured comprehensively using various patient-reported outcome measures (PROMs) to provide information on the effect of knee arthroplasty on pain, satisfaction, physical activity, activities of daily living, and quality of life.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable knee-osteoarthritis

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

Study Start

First participant enrolled

March 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

2.7 years

First QC Date

July 26, 2017

Last Update Submit

July 27, 2017

Conditions

Keywords

knee arthroplastyworking-agepatient related outcome measures

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of contemporary knee arthroplasty in working-age patients

    PROMs

    2 years

Study Arms (1)

working age patients

OTHER

Prospective cohort of 250 patients.

Other: Knee arthroplasty

Interventions

Effectiveness of knee arthroplasty surgery.

working age patients

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 65 or less and
  • Scheduled for either TKA or unicondylar knee arthroplasty (UKA)

You may not qualify if:

  • rheumatoid arthritis or other inflammatory diseases
  • unwilling to provide informed consent
  • physical, mental, or neurological conditions that could comprise the patient´s ability and compliance with postoperative rehabilitation and follow-up (e.g., drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson's disease, multiple sclerosis (MS), etc.)
  • known sensitivity to materials in the devices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Leppanen S, Niemelainen M, Huhtala H, Eskelinen A. Mild knee osteoarthritis predicts dissatisfaction after total knee arthroplasty: a prospective study of 186 patients aged 65 years or less with 2-year follow-up. BMC Musculoskelet Disord. 2021 Aug 5;22(1):657. doi: 10.1186/s12891-021-04543-8.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 28, 2017

Study Start

March 1, 2012

Primary Completion

October 30, 2014

Study Completion

November 1, 2016

Last Updated

July 28, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share