NCT02050438

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

July 28, 2014

Status Verified

July 1, 2014

Enrollment Period

6 months

First QC Date

January 29, 2014

Last Update Submit

July 25, 2014

Conditions

Osteoarthritis KneeTotal Knee Replacement

Keywords

Osteoarthritis KneeTotal Knee ArthroplastyQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    6 months

Secondary Outcomes (1)

  • Functional Results

    6 months

Study Arms (1)

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

Total Knee ArthroplastyPROCEDURE
Also known as: Total Knee Prostesis
Knee Osteoarthritis patients with prostesis treatment

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients operated Total Knee Arthroplasty 6 months previously the observational study

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

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 Officials

  • Jordi Villaba-Modol, MD

    Corporacio Sanitaria Parc Tauli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 29, 2014

First Posted

January 30, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Last Updated

July 28, 2014

Record last verified: 2014-07

Locations

ES(1)