## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 20180532
#### Organization
**Class:** OTHER
**Full Name:** Ottawa Hospital Research Institute
### Status Module
#### Completion Date
**Date:** 2023-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-08-08

**Type:** ACTUAL

**Last Update Submit Date:** 2022-08-05

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2023-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-04-29

**Type:** ACTUAL

**Status Verified Date:** 2022-08

#### Study First Post Date
**Date:** 2019-09-26
**Type:** ACTUAL
**Study First Submit Date:** 2018-09-13
**Study First Submit QC Date:** 2019-09-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Ottawa

#### Lead Sponsor

**Class:** OTHER

**Name:** Ottawa Hospital Research Institute

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Osteoarthritis, Knee

- Inflammation Knees

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 75

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: Zimmer NexGen LPS-Flex

- Device: Smith & Nephew Journey II

**Label:** Implant Groups

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Control group that will not be undergoing a total knee arthroplasty

**Label:** Healthy Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Implant Groups

**Description:** Patients will be randomly assigned to 1 of 2 devices

**Name:** Zimmer NexGen LPS-Flex

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Implant Groups

**Description:** Patients will be randomly assigned to 1 of 2 devices

**Name:** Smith & Nephew Journey II

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

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

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

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

**Measure:** Change from baseline muscle quality assessed via MRI at 12 months

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

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

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

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

#### Secondary Outcomes

**Description:** 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.

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

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

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 45 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** wgofton@toh.ca

**Name:** Wade Gofton, MD FRCSC

**Phone:** 6137985555

**Phone Ext:** 18779

**Role:** CONTACT

**Contact 2:**

**Email:** meadufresne@ohri.ca

**Name:** Meaghan Dufresne

**Phone:** 613-737-8899

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Ottawa

**Country:** Canada

**Facility:** The Ottawa Hospital

**State:** Ontario

**Status:** RECRUITING

**Zip:** K1H 8L6

#### Overall Officials

**Official 1:**

**Affiliation:** University of Ottawa

**Name:** Mario Lamontagne, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Ottawa

**Name:** Isabelle Catelas, PhD, PEng

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010003

- Term: Osteoarthritis

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: LOW

- As Found: Unknown

- ID: M22168

- Name: Osteoarthritis, Knee

- Relevance: HIGH

- As Found: Osteoarthritis, Knee

- ID: M10293

- Name: Inflammation

- Relevance: HIGH

- As Found: Inflammation

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020370

- Term: Osteoarthritis, Knee

- ID: D000007249

- Term: Inflammation

### Misc Info Module

- Version Holder: 2024-05-24
