Outcome EnduRo Versus LINK SL Rotating Hinge Knee

Knee Arthrosis, Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01952938
• Other study ID #: AAG-I-H-1112
• Status: Recruiting
• Phase: N/A
• First received: September 25, 2013
• Last updated: September 27, 2013
• Start date: July 2012

Study information

• Verified date: September 2013
• Source: Orthopaedische Klinik Koenig-Ludwig-Haus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Randomized clinical outcome study of two rotating hinge knee prosthesis in knee surgery. Hypothesis: No difference in the clinical outcome for 1 year after the operation. Clinical follow-ups at 3, 10, 90 and 360 days after surgery. Measurement of clinical parameters

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• rotating hinge knee indicated

Exclusion Criteria:

• infection,

• malignant tumor,

• rheumatism

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Knee Arthrosis,

Intervention

Procedure:
• LINK SL versus EnduRo

Locations

Country	Name	City	State
Germany	Orthopeadische Klinik KLH	Wuerzburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Orthopaedische Klinik Koenig-Ludwig-Haus

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford knee score		one year	No