Custom Cutting Block Instrument vs Regular Instrumentation Total Knee Replacement (TKR)

Osteoarthritis, Knee Clinical Trial

Official title:

A Double-blinded, Randomized, Controlled Trial of Total Knee Replacement Using Custom Cutting Block Instrument vs Regular Instrumentation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03416946
• Other study ID #: HS13322
• Status: Completed
• Phase: N/A
• Start date: December 1, 2011
• Est. completion date: May 1, 2017

Study information

• Verified date: September 2021
• Source: Orthopaedic Innovation Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. Functional and radiographic outcomes will be assessed in a blinded fashion. The Smith and Nephew Legion Primary® total knee system will be used in both groups; this is an implant with a good long term track record based on the Genesis II design. All surgeons have used and are familiar with the regular instrumentation. They will be instructed in the use of the patient-specific custom cutting blocks prior to study initiation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient is male or female ages 18 and over.

2. Patient is having primary total knee replacement

3. Patient is willing to sign the informed consent and to come for all study visits.

Exclusion Criteria:

1. Deformity of the femur preventing use of the intra-medullary guide utilized in the regular instrumentation set.

2. 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.

3. 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.

4. Patients scheduled for bilateral knee surgery (simultaneous or staged)

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Device:
• Visionaire
Custom cutting block using MRI to create patient specific instrumentations

Other:
• Traditional
Traditional cutting method

Locations

Country	Name	City	State
Canada	Concordia Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Orthopaedic Innovation Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other Measure: Time	Surgical and tourniquet time	Intra-operative
Other	Blood Loss	Blood loss during surgery >100ml (n)	Intra-operative
Other	Length of Stay (LOS)	Length of hospital stay	Peri-operative
Other	Other Measures: Adverse Events	Peri-operative complications such as deep venous thrombosis, pulmonary emboli, wound complications and cardiac events.; Post-operative complication such as infection, loosening, etc.	Peri-operative, intra-operative and post-operative
Primary	Radiographic Alignment	Using 3 foot standing film	8 Weeks
Primary	Number of HKA Angle Outliers	The angle formed between the mechanical axes of the femur and tibia create the hip-knee-ankle (HKA) angle.	8 Weeks
Secondary	EuroQol (EQ) Five Dimension (5D) Survey	Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the EQ-5D (patient reported). The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state, this health state is range from 0 to 1.0. Higher scores indicate improved quality of life within each dimension.	Preoperative, 1 and 2 years
Secondary	Oxford Knee Score	Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Oxford 12 scores (patient reported). The score ranges from 0 to 48 with higher scores indicating improved function and less pain.	Preoperative, 1 and 2 years
Secondary	Pain Catastrophizing Scale (PCS) Score	Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the PCS (patient reported). The total score ranges from 0 to 52 with higher scores indicating greater pain catastrophizing. Sub-scales will not be used in this study.	Preoperative, 1 and 2 years
Secondary	Hip Pain	Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Pain Visual Analog Scale (VAS). The scale is from 0 to 100, 0=no pain and at 100= worst pain. (patient reported).	Preoperative, 1 and 2 years
Secondary	University of California Los Angeles (UCLA) Activity Score	Evaluate change from preoperative baseline to 1 and 2 year post operative in activity level assessments using the UCLA Activity score (patient reported). The scale ranges from 1-10 with higher values associated with more intense activities.	Preoperative, 1 and 2 years
Secondary	Patient Satisfaction	Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Satisfaction Visual Analog Scale (VAS). The scale is from 0 to 100, 0=Not Satisfied and at 100=Satisfied. (patient reported).	Preoperative, 1 and 2 years