Outcome EnduRo Versus LINK SL Rotating Hinge Knee
1 other identifier
observational
50
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 25, 2013
CompletedFirst Posted
Study publicly available on registry
September 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedSeptember 30, 2013
September 1, 2013
2 years
September 25, 2013
September 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxford knee score
one year
Study Arms (2)
LINK SL
Patients
EnduRo
Patients
Interventions
Eligibility Criteria
Patients need hinged knee prosthesis
You may qualify if:
- rotating hinge knee indicated
You may not qualify if:
- infection,
- malignant tumor,
- rheumatism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orthopeadische Klinik KLH
Würzburg, Bavaria, 97074, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2013
First Posted
September 30, 2013
Study Start
July 1, 2012
Primary Completion
July 1, 2014
Last Updated
September 30, 2013
Record last verified: 2013-09