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How TKA Implants Affect Muscle Quality and Activity During Daily Living and Immunological Response

Primary Purpose

Osteoarthritis, Knee, Inflammation Knees

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Zimmer NexGen LPS-Flex

Smith & Nephew Journey II

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The participants receiving a knee implant must requiring a total knee replacement

Exclusion Criteria:

Any degenerative conditions (other than osteoarthritis at the affected knee) impacting joints of the lower extremities
bilateral knee replacements
previous joint replacement at the affected knee
any other past or present conditions that may impact gait
any active infection and any diagnosed conditions that may affect the local and systemic immune response (e.g., rheumatoid arthritis, HIV infection, lupus, pregnancy, and thrombocytosis)
BMI and waist circumference (WC) will be another exclusion criterion since both BMI and WC are associated with health problems and gait abnormalities. Any patient with both BMI > 35 kg/m2 and a WC > 102 cm in men or > 88 cm in women will be excluded from the study.

Healthy Controls Inclusion

controls must not suffer from lower extremity injuries or joint conditions that might alter gait dynamics Exclusion
BMI and waist circumference (WC) will be another exclusion criterion since both BMI and WC are associated with health problems and gait abnormalities. Any patient with both BMI > 35 kg/m2 and a WC > 102 cm in men or > 88 cm in women will be excluded from the study

Sites / Locations

The Ottawa HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Implant Groups

Healthy Control Group

Arm Description

Group will receive the Smith & Nephew Journey II knee implant or the Zimmer NexGen LPS-Flex knee implant

Control group that will not be undergoing a total knee arthroplasty

Outcomes

Primary Outcome Measures

Change from baseline knee extension moment at 6 and 12 months during gait

Peak knee extension moment will be measured by combining three-dimensional images of movement with time, the knee extension will be calculated in degrees while the participant walks at their normal walking speed.

Change from baseline muscle quality assessed via MRI at 12 months

Proton density fat fraction of the quadriceps and hamstrings muscles will be measured via MRI

Change from baseline quadriceps muscle activation at 6 and 12 months during gait

Peak muscle activation of the quadriceps muscle will be measured with electromyography while the participant walks at their normal walking speed

Secondary Outcome Measures

Change in trace metal concentrations from baseline, 12 months, and 24 months

Peripheral blood will be collected prior to surgery and at 12 months post-surgery; for symptomatic patients, a third blood draw will occur at 24 months post-surgery. Concentrations of cobalt, chromium, and Nickle will be measured by inductively coupled plasma-mass spectrometry.

Full Information

NCT ID

NCT04105179

First Posted

September 13, 2018

Last Updated

August 5, 2022

Sponsor

Ottawa Hospital Research Institute

Collaborators

University of Ottawa

1. Study Identification

Unique Protocol Identification Number

NCT04105179

Brief Title

How TKA Implants Affect Muscle Quality and Activity During Daily Living and Immunological Response

Official Title

Do TKA Implant Designs Affect Muscle Mass Change and Muscle Activity During Activities of Daily Living as Well as the Patient Immunological Response

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 29, 2019 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Hospital Research Institute

Collaborators

University of Ottawa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study compares two total knee replacement implants to asses muscle function and quality, and the immune response to the implants. 30 patients will receive the Smith and Nephew Journey II implant, while 30 patients will receive the Zimmer NexGen LPS-flex implant. 15 healthy controls will also be recruited and compared.

Detailed Description

Patients will undergo biomechanics testing while they complete sit-to-stand, stand-to-sit, lateral step down, level walking, and single leg balance tasks up to 1 month before surgery, and 6 and 12 months after surgery. They will also undergo MRI imaging up to 1 month before surgery and 12 months after surgery to assess muscle quality. A secondary outcome will also be to analyze the immunological response in the patients who received femoral components made of oxidized zirconium versus contemporary components made of cobalt chrome. Fifteen healthy controls will also participate in the study and will undergo the biomechanical, MRI and blood draws at a single visit.

6. Conditions and Keywords

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

Osteoarthritis, Knee, Inflammation Knees

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Implant Groups

Arm Type

Experimental

Arm Description

Group will receive the Smith & Nephew Journey II knee implant or the Zimmer NexGen LPS-Flex knee implant

Arm Title

Healthy Control Group

Arm Type

No Intervention

Arm Description

Control group that will not be undergoing a total knee arthroplasty

Intervention Type

Device

Intervention Name(s)

Zimmer NexGen LPS-Flex

Intervention Description

Patients will be randomly assigned to 1 of 2 devices

Intervention Type

Device

Intervention Name(s)

Smith & Nephew Journey II

Intervention Description

Patients will be randomly assigned to 1 of 2 devices

Primary Outcome Measure Information:

Title

Change from baseline knee extension moment at 6 and 12 months during gait

Description

Time Frame

Baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls

Title

Change from baseline muscle quality assessed via MRI at 12 months

Description

Proton density fat fraction of the quadriceps and hamstrings muscles will be measured via MRI

Time Frame

Baseline (within 1 month of surgery), 12 months post-surgery; and versus healthy controls

Title

Change from baseline quadriceps muscle activation at 6 and 12 months during gait

Description

Peak muscle activation of the quadriceps muscle will be measured with electromyography while the participant walks at their normal walking speed

Time Frame

Baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls

Secondary Outcome Measure Information:

Title

Change in trace metal concentrations from baseline, 12 months, and 24 months

Description

Time Frame

Baseline (within 1 month of surgery), 12 months post-surgery, 24 months post-surgery; and versus healthy controls

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The participants receiving a knee implant must requiring a total knee replacement Exclusion Criteria: Any degenerative conditions (other than osteoarthritis at the affected knee) impacting joints of the lower extremities bilateral knee replacements previous joint replacement at the affected knee any other past or present conditions that may impact gait any active infection and any diagnosed conditions that may affect the local and systemic immune response (e.g., rheumatoid arthritis, HIV infection, lupus, pregnancy, and thrombocytosis) BMI and waist circumference (WC) will be another exclusion criterion since both BMI and WC are associated with health problems and gait abnormalities. Any patient with both BMI > 35 kg/m2 and a WC > 102 cm in men or > 88 cm in women will be excluded from the study. Healthy Controls Inclusion controls must not suffer from lower extremity injuries or joint conditions that might alter gait dynamics Exclusion BMI and waist circumference (WC) will be another exclusion criterion since both BMI and WC are associated with health problems and gait abnormalities. Any patient with both BMI > 35 kg/m2 and a WC > 102 cm in men or > 88 cm in women will be excluded from the study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wade Gofton, MD FRCSC

Phone

6137985555

Ext

18779

wgofton@toh.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Meaghan Dufresne

Phone

613-737-8899

meadufresne@ohri.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mario Lamontagne, PhD

Organizational Affiliation

University of Ottawa

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Isabelle Catelas, PhD, PEng

Organizational Affiliation

University of Ottawa

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ottawa Hospital

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

How TKA Implants Affect Muscle Quality and Activity During Daily Living and Immunological Response

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