Time-dependent Improvement of Functional Outcome Followin... | NCT01030848

Studies
Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR

NCT01030848

Sponsor

Vestre Viken Hospital Trust

Status

Unknown status

Last Update Posted

Dec 15, 2009Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Osteoarthritis
Total Knee Replacement

Interventions

Total Knee Replacement (LCS rotating platform)

Countries

Norway

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
19039 (NSD)	Registry Identifier	Norwegian Privacy Ombudsman for Research

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2003

Primary Completion Date

Sep 2007Actual

Completion Date

Sep 2013Estimated

First Submitted Date

Dec 11, 2009

First Submission Date that Met QC Criteria

Dec 11, 2009

First Posted Date

Dec 14, 2009Estimated

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

Dec 14, 2009

Last Update Posted Date

Dec 15, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first four years following TKR using the LCS rotating platform prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with knee osteoarthritis			Device: Total Knee Replacement (LCS rotating platform)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total Knee Replacement (LCS rotating platform)	Device		Patients with knee osteoarthritis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Knee injury and Osteoarthritis Outcome Score		Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Range of Motion (ROM)		Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively
Knee injury and Osteoarthritis Outcome Score		10 years postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with knee osteoarthritis
admitted for total knee replacement
no rheumatoid arthritis
no previous knee infection
age 40-85 years

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients operated with total knee arthroplasty at Martina Hansens Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tor Kjetil Nerhus, MD	Martina Hansens Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Martina Hansens Hospital		Bærum	Bærum	1306	Norway

Type	Date	Date Unknown
Release	Oct 25, 2013
Reset	Dec 16, 2013
Release	Nov 10, 2023
Reset	Apr 25, 2024

Submission Tracking

Estimated Results First Submitted Date

Oct 25, 2013

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 25, 2013			Dec 16, 2013
Nov 10, 2023

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019645	Arthroplasty, Replacement, Knee

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided