Status:
COMPLETED
Custom Cutting Block Instrument vs Regular Instrumentation Total Knee Replacement (TKR)
Lead Sponsor:
Orthopaedic Innovation Centre
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To determine if the use of patient-specific custom cutting blocks for implantation of total knee components results in improved limb alignment and component positioning compared to regular instrumenta...
Detailed Description
This is a randomized controlled trial. Patients will be randomized to have their knee implanted using either the patient-specific custom cutting blocks or the regular instrumentation system. Functiona...
Eligibility Criteria
Inclusion
- Patient is male or female ages 18 and over.
- Patient is having primary total knee replacement
- Patient is willing to sign the informed consent and to come for all study visits.
Exclusion
- Deformity of the femur preventing use of the intra-medullary guide utilized in the regular instrumentation set.
- Necessity for the use of constrained implants. These types of implants have intra-medullary stems, therefore all bone cuts need to be referenced off intramedullary guides, making image guided bone cuts inappropriate.
- Patients undergoing knee replacement revision surgery. Theses types of implants also have stems, making the use of image guided bone cuts inappropriate for the same reasons.
- Patients scheduled for bilateral knee surgery (simultaneous or staged)
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03416946
Start Date
December 1 2011
End Date
May 1 2017
Last Update
October 4 2021
Active Locations (1)
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1
Concordia Hospital
Winnipeg, Manitoba, Canada, R2K 3S8