How Total Knee Prosthesis Dessigns Influence in Quality o... | NCT02050438

Studies
How Total Knee Prosthesis Dessigns Influence in Quality of Live

NCT02050438

Sponsor

Corporacion Parc Tauli

Status

Completed

Last Update Posted

Jul 28, 2014Estimated

Enrollment

135Estimated

Phase

Not provided

Conditions

Osteoarthritis Knee
Total Knee Replacement

Interventions

Total Knee Arthroplasty

Countries

Spain

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 2014

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

Jan 2014

Primary Completion Date

Jul 2014Actual

Completion Date

Not provided

First Submitted Date

Jan 29, 2014

First Submission Date that Met QC Criteria

Jan 29, 2014

First Posted Date

Jan 30, 2014Estimated

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 25, 2014

Last Update Posted Date

Jul 28, 2014Estimated

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 purpose of this study is to determine whether different kind of prostesis designs influences in the quality of life of patients

Detailed Description

Objectiu Criteris d'inclusió Mesura dels resultats

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

135Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Knee Osteoarthritis patients with prostesis treatment		Patients operated previously of Knee Osteoarthritis with different prostesis designs according the Hospital guide	Procedure: Total Knee Arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total Knee Arthroplasty	Procedure		Knee Osteoarthritis patients with prostesis treatment	Total Knee Prostesis

Measure	Description	Time Frame
Quality of Life		6 months

Measure	Description	Time Frame
Functional Results		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 65-80 years.
Primary Ostheortritis
Mechanical Axis 0+/- 7 degrees

Exclusion Criteria:

Patients with any new important disease after the surgical procedure.
Important complications related with the surgical procedure, as fractures, infections and vascular lesions.
Patients not following a rehabilitation program

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

80 Years

Standard Ages

Older Adult

Study Population

Patients operated Total Knee Arthroplasty 6 months previously the observational study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jordi Villaba-Modol, MD	Corporacio Sanitaria Parc Tauli	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Corporació Sanitària Parc Taulí		Sabadell	Barcelona	08208	Spain

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal 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