NCT01952938

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

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

September 30, 2013

Status Verified

September 1, 2013

Enrollment Period

2 years

First QC Date

September 25, 2013

Last Update Submit

September 27, 2013

Conditions

Keywords

knee revision surgery,rotating hinge prosthesis

Outcome Measures

Primary Outcomes (1)

  • Oxford knee score

    one year

Study Arms (2)

LINK SL

Patients

Procedure: LINK SL versus EnduRo

EnduRo

Patients

Procedure: LINK SL versus EnduRo

Interventions

EnduRoLINK SL

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

RECRUITING

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

Locations