N/A
N=54
Custom Cutting Block Instrument vs Regular Instrumentation Total Knee Replacement (TKR)
Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT03416946 ↗Enrolled (actual)
54
Serious AEs
9.3%
Results posted
Oct 2021
Primary outcome: Primary: Radiographic Alignment — -1.6; -1.8; 89.4; 89.3 degree — p=0.790
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Visionaire (Device); Traditional (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Orthopaedic Innovation Centre
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiographic Alignment |
-1.6; -1.8; 89.4; 89.3; 89.2; 89.1 | 0.790 |
| PRIMARY Number of HKA Angle Outliers |
6; 10 | — |
| SECONDARY EuroQol (EQ) Five Dimension (5D) Survey |
0.760; 0.744; 0.101; 0.110; 0.112; 0.120 | — |
| SECONDARY Oxford Knee Score |
22.8; 19.6; 10.7; 15.3; 13.3; 12.8 | — |
| SECONDARY Pain Catastrophizing Scale (PCS) Score |
14.0; 17.4; 9.1; 10.5; 8.0; 6.4 | — |
| SECONDARY Hip Pain |
61.6; 67.4; -38.4; -40.1; -40.8; -46.3 | — |
| SECONDARY University of California Los Angeles (UCLA) Activity Score |
4.4; 3.4; 0.8; 1.6; 1.0; 1.6 | — |
| SECONDARY Patient Satisfaction |
23.0; 25.6; 59.1; 57.4; 62.0; 56.0 | — |
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 instrumentation.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03416946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.