Effectiveness of Contemporary Knee Arthroplasty in Workin... | NCT03233620

Studies
Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients

NCT03233620

Sponsor

Coxa, Hospital for Joint Replacement

Status

Completed

Last Update Posted

Jul 28, 2017Actual

Enrollment

250Actual

Phase

Not Applicable

Conditions

Knee Osteoarthritis

Interventions

Knee arthroplasty

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2012Actual

Primary Completion Date

Oct 30, 2014Actual

Completion Date

Nov 1, 2016Actual

First Submitted Date

Jul 26, 2017

First Submission Date that Met QC Criteria

Jul 27, 2017

First Posted Date

Jul 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2017

Last Update Posted Date

Jul 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
working age patients	Other	Prospective cohort of 250 patients.	Other: Knee arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Knee arthroplasty	Other	Effectiveness of knee arthroplasty surgery.	working age patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effectiveness of contemporary knee arthroplasty in working-age patients	PROMs	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34353317	Derived	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.

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative