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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02050438
Other study ID # COTCSPT1JV
Secondary ID
Status Completed
Phase N/A
First received January 29, 2014
Last updated July 25, 2014
Start date January 2014

Study information

Verified date July 2014
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority Spain: Departament de Salut de la Generalitat de Catalunya
Study type Observational

Clinical Trial Summary

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


Description:

Objectiu Criteris d'inclusiĆ³ Mesura dels resultats


Recruitment information / eligibility

Status Completed
Enrollment 135
Est. completion date
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 65 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

Procedure:
Total Knee Arthroplasty


Locations

Country Name City State
Spain Corporació Sanitària Parc Taulí Sabadell Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life 6 months No
Secondary Functional Results 6 months No
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