Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement

Osteo Arthritis Knee Clinical Trial

Official title:

Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement: A Multi-Center, Non-Controlled, Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06189872
• Other study ID #: ATTUNE2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: June 2027

Study information

• Verified date: December 2023
• Source: Canadian Radiostereometric Analysis Network
• Contact: Sarah Tran
• Phone: 204-926-1231
• Email: stran[@]orthoinno.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-centre, single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System.

Description:

All patients will undergo post-operative radiostereometric analysis (RSA) and computed tomography (CT) to quantify and characterize the in vivo migration pattern of the Attune AFFIXIUM Cementless Tibial Baseplate and the Attune POROCOAT Cementless Femoral Component up to 24 months. Patient health and functional outcomes will be recorded at pre- and post-operative intervals for all patients. Peri-operative adverse events and other clinical complications will be captured as encountered.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty

• Patients aged 21 years or older

• Sufficient ligamentous function to warrant retention of the posterior cruciate ligament

• Patients willing and able to comply with follow-up requirements and self-evaluations

• Ability to give informed consent

Exclusion Criteria:

• Active or prior infection of ipsilateral extremity

• Medical condition precluding major surgery

• Inflammatory arthropathy

• Posterior cruciate ligament (PCL) deficiency

• Major coronal plane deformity

• Conditions that are cautioned against or contraindicated, as listed in the product monograph and/or instruction for use

• Bone defects requiring augments, cones and/or stemmed implants

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Attune Cementless
Attune AFFIXIUM Cementless Tibial Baseplate, Fixed Bearing Attune POROCOAT Cementless Femoral Component, Cruciate Retaining Attune AOX Antioxidant Polyethylene Tibial Insert, Cruciate Retaining Attune AOX Patellar Button, Domed or Medialized Dome, Cemented or Cementless (surgeon preference for resurfacing)

Locations

Country	Name	City	State
Canada	Nova Scotia Health - Orthopedic	Halifax	Nova Scotia
Canada	London Health Sciences Centre	London	Ontario
Canada	Orthopaedic Innovation Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Canadian Radiostereometric Analysis Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tibial baseplate stability	Maximum total point motion (MTPM) migration between 6-12 months and 1-2 year post-operative (mm)	6-12 months, 1-2 years post-operative
Secondary	Femoral component migration	To quantify and characterize femoral component migration up to 24 months after surgery	Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years
Secondary	Tibial baseplate migration	To quantify and characterize tibial baseplate migration between weight-bearing and non-weight-bearing examinations at 24 months after surgery.	Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years
Secondary	Equivalency between CT-RSA-measured migration and the gold-standard of RSA-measured migration	To assess equivalency between CT-RSA-measured migration and the gold-standard of RSA-measured migration for both tibial and femoral migration	Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years
Secondary	European Quality of Life (EQ-5D-5L)	EQ5D consists of 5 subscales; Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety / depression. A health state score is obtained based on the responses from 1-5 in each subscale, from which a single index value is calculated representing patients' overall health state. EQ5D includes a so called EQ VAS score which is the patients' self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled "the best health you can imagine" and "the worst health you can imagine".	Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Secondary	Oxford Knee Score	The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OKS measures pain and general activities of daily living.	Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Secondary	Forgotten Joint Score (FJS)	The FJS total score range is 0-100, higher scores indicating the patient is able to forget the joint daily or lower degree of joint awareness.	Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Secondary	Satisfaction VAS	Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported pain severity as measured using the visual analogue scale (VAS) from 0 (Unsatisfied) - 100 (Completely satisfied)	Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Secondary	Patient complications	Evaluate the type and frequency of the complications/adverse events.	Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Secondary	Linear depth (wear) on the tibial insert	To estimate linear depth (wear) on the tibial insert (experimental).	Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years