Porous Baseplate in Total Knee Replacement

Back to results

Primary Purpose

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

POROUS TIBIA BASEPLATE W/ JRNY LOCK

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Symptomatic osteoarthritis of the knee indicating primary unilateral total knee arthroplasty
Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
Aged 21 years or older
Patients willing and able to comply with follow-up requirements and self-evaluations
Ability to give informed consent

Exclusion Criteria:

Active or prior infection
Medical condition precluding major surgery
Known medical condition limiting patient life expectancy to < 2 years
Expected to receive contralateral TKA within 1 year
Inflammatory arthropathy
Prior patellectomy
PCL deficiency
Major (>25 degree) coronal plane deformity
Bilateral coronal plane deformity requiring simultaneous bilateral TKA
Bone defects requiring augments, cones and/or stemmed implants
Body Mass Index greater than 40

Sites / Locations

Concordia Hospital
London Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

POROUS TIBIA BASEPLATE W/ JRNY LOCK

Arm Description

Fixed-bearing POROUS TIBIA BASEPLATE W/ JRNY LOCK and a Legion cruciate-retaining High-Flex or Deep-dish XLPE tibial insert.

Outcomes

Primary Outcome Measures

Change between 6 months and 1-year post-operative - tibial baseplate stability

Maximum total point motion (MTPM) migration of the POROUS TIBIA BASEPLATE W/ JRNY LOCK between 6 months and 1 year post-operative (mm)

Secondary Outcome Measures

Change between 1- and 2-years post-operative - tibial baseplate stability

Maximum total point motion (MTPM) migration of the POROUS TIBIA BASEPLATE W/ JRNY LOCK between 1 year and 2 years post-operative (mm)

Total MTPM migration of the baseplate at 1 year

Assessment of the stability of the tibial baseplate (mm)

Establish the post-operative migration pattern of the patellar and femoral components

Assessment of the migration pattern (mm)

What is the magnitude of baseplate displacement that results from patient weight-bearing (single leg stance) versus non-weight-bearing at 1-year post-operation?

Assessment of the baseplate displacement differences between standing and supine RSA (mm)

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".

Patient-reported Outcome: 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.

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.

Knee Injury and Osteoarthritis Outcomes Score (KOOS JR.)

The KOOS JR. was a participant completed questionnaire that consists of 7 questions from 3 subscales: stiffness (1 question), pain (4 questions), and function in daily living (2 questions). Standardized answer options are given (5 Likert boxes) and each question was assigned a score from none (0) to extreme (4).

University of California at Los Angeles (UCLA) Activity Level scale

Evaluate and compare the change in UCLA activity score compared to baseline in the study cohort. UCLA activity scores range from 1 to 10, and is a measure of activity with 10 being most active.

Pain VAS

Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (No pain) - 100 (Worst pain imaginable)

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)

Patient complications

Evaluate the type and frequency of the complications/adverse events.

Full Information

NCT ID

NCT05226689

First Posted

January 3, 2022

Last Updated

June 26, 2023

Sponsor

Canadian Radiostereometric Analysis Network

1. Study Identification

Unique Protocol Identification Number

NCT05226689

Brief Title

Porous Baseplate in Total Knee Replacement

Official Title

A Prospective, Multicenter, RSA Study of the Porous Tibia Baseplate W/Jrny Lock

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 11, 2022 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Canadian Radiostereometric Analysis Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

This is a multi-centre single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Advance Porous fixed bearing tibial baseplate and compatible femoral, patellar, and bearing components.

Detailed Description

All patients will undergo post-operative model-based RSA to identify migration of the tibial baseplate with respect to the bone as well as migration of the patellar and femoral components with respect to the bone during the first 2 post-operative years. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

POROUS TIBIA BASEPLATE W/ JRNY LOCK

Arm Type

Other

Arm Description

Fixed-bearing POROUS TIBIA BASEPLATE W/ JRNY LOCK and a Legion cruciate-retaining High-Flex or Deep-dish XLPE tibial insert.

Intervention Type

Device

Intervention Name(s)

POROUS TIBIA BASEPLATE W/ JRNY LOCK

Intervention Description

Fixed-bearing POROUS TIBIA BASEPLATE W/ JRNY LOCK and a Legion cruciate-retaining High-Flex or Deep-dish XLPE tibial insert

Primary Outcome Measure Information:

Title

Change between 6 months and 1-year post-operative - tibial baseplate stability

Description

Maximum total point motion (MTPM) migration of the POROUS TIBIA BASEPLATE W/ JRNY LOCK between 6 months and 1 year post-operative (mm)

Time Frame

6 Months and 1 Year

Secondary Outcome Measure Information:

Title

Change between 1- and 2-years post-operative - tibial baseplate stability

Description

Maximum total point motion (MTPM) migration of the POROUS TIBIA BASEPLATE W/ JRNY LOCK between 1 year and 2 years post-operative (mm)

Time Frame

1 Year and 2 Years

Title

Total MTPM migration of the baseplate at 1 year

Description

Assessment of the stability of the tibial baseplate (mm)

Time Frame

1 Year

Title

Establish the post-operative migration pattern of the patellar and femoral components

Description

Assessment of the migration pattern (mm)

Time Frame

6 Weeks and 6 Months

Title

What is the magnitude of baseplate displacement that results from patient weight-bearing (single leg stance) versus non-weight-bearing at 1-year post-operation?

Description

Assessment of the baseplate displacement differences between standing and supine RSA (mm)

Time Frame

1 Year

Title

European Quality of Life (EQ-5D-5L)

Description

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".

Time Frame