Patellar Resurfacing in Total Knee Arthroplasty | NCT00553982

Studies
Patellar Resurfacing in Total Knee Arthroplasty

NCT00553982

Sponsor

Sykehuset Innlandet HF

Status

Completed

Last Update Posted

Apr 15, 2016Estimated

Enrollment

130Actual

Phase

Not Applicable

Conditions

Osteoarthritis
Pain

Interventions

Patellar component
No patellar component

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

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

Apr 2016

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

Oct 2007

Primary Completion Date

Jun 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Nov 2, 2007

First Submission Date that Met QC Criteria

Nov 5, 2007

First Posted Date

Nov 6, 2007Estimated

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

Apr 14, 2016

Last Update Posted Date

Apr 15, 2016Estimated

Description Module

Brief Summary

Background:

The best treatment of the patella during total knee arthroplasty (TKA) is controversial. The implantation of a patellar component adds to the operation time and the costs of the operation.There is a huge variation as to whether the patella is resurfaced or not during TKA. Meta-analysis of prospective, randomised trials might indicate that patellar resurfacing reduces the risk of reoperation and anterior knee pain, but drawing firm conclusions is not possible and additional, high quality randomised trials are required.

Purpose:

The aim of this study is to determine whether ther is a difference between the two groups in knee pain, functions, patient satisfaction and quality of life after TKA.

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

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Patellar resurfacing	Procedure: Patellar component
2	Active Comparator	Patellar retention	Procedure: No patellar component

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patellar component	Procedure	Resurfacing with onlay technique	1
No patellar component

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Knee injury and Osteoarthritis Outcome Score		3 years follow up

Secondary Outcomes

Measure	Description	Time Frame
Oxford score, Knee Society score, Stair climbing test, Pain (VAS), Patient satisfaction (VAS)		3 years follow up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients less than 85 years old with osteoarthritis scheduled for primary knee arthroplasty.

Exclusion Criteria:

Patients who are not able to cooperate
Serious deformity (not suitable for a standard CR prosthesis)
Patellar thickness less than 18 mm
Prior operation involving the extensor mechanism
Rheumatoid arthritis
Severe medical disability limiting the ability to walk
Revision surgery
Knees with predominantly patellofemoral arthrosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eirik Aunan, Doctor	Sykehuset Innlandet, Lillehammer	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sykehuset Innlandet HF, Lillehammer		Lillehammer		2629	Norway

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D010146	Pain
D000092462	Patella Fracture

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
40-07172b 1.2007.952 (REK)
13-2007 SI (Personvernombudet)