Quadriceps Sparing Versus Standard Total Knee Arthroplasty

NCT03081663 | Completed

• 1 other identifier: 108949
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized clinical trial comparing standard medial para-patellar total knee arthroplasty with a quadriceps sparing mid-vastus approach. Patients who are medically well and have a good support structure at home will be randomized to a standard or quadriceps sparing surgical approach stratified by type of analgesia (adductor canal block or local infiltration). We will compare patient satisfaction and costs from the perspective of the Ministry of Health, the institution, society and the patient.

Conditions

Knee Osteoarthritis; Knee Arthroplasty

Keywords

total knee arthroplasty; quadriceps sparing mid-vastus; medial para-patellar

Outcome Measures

Primary Outcomes (1)

• Indirect and Direct Costs of Treatment

  ER visits, clinician visits, caregiver lost productivity, tests, etc.

  1 year

Secondary Outcomes (10)

• Pain Numeric Rating Scale

  1 year

• Short Form - 12 (SF-12)

  1 year

• Western Ontario McMaster Osteoarthritis Index (WOMAC)

  1 year

• Knee Society Score (KSS)

  1 year

• EuroQol-5D (EQ-5D)

  1 year

Study Arms (4)

Quads-Sparing Approach with Tourniquet

EXPERIMENTAL

Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and a tourniquet.

Procedure: Quads-Sparing Approach

Medial Para-Patellar with Tourniquet

ACTIVE COMPARATOR

Participants will undergo total knee arthroplasty with a medial para-patellar approach and a tourniquet. An intramedullary femoral guide and extramedullary tibial guide will be used during the surgery.

Procedure: Medial Para-Patellar Approach

Quads-Sparing Approach w/o Tourniquet

ACTIVE COMPARATOR

Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and no tourniquet.

Procedure: Quads-Sparing Approach

Medial Para-Patellar w/o Tourniquet

ACTIVE COMPARATOR

Participants will undergo total knee arthroplasty with a medial para-patellar approach and no tourniquet. An intramedullary femoral guide and extramedullary tibial guide will be used during the surgery.

Procedure: Medial Para-Patellar Approach

Interventions

Quads-Sparing Approach PROCEDURE

Quadriceps-sparing mid-vastus approach for total knee arthroplasty

Also known as: quads-sparing

Quads-Sparing Approach w/o Tourniquet; Quads-Sparing Approach with Tourniquet

Medial Para-Patellar Approach PROCEDURE

Medial para-patellar approach for total knee arthroplasty

Also known as: standard

Medial Para-Patellar w/o Tourniquet; Medial Para-Patellar with Tourniquet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients requiring primary total knee replacement
• patients willing and able to comply with follow-up requirements and self-evaluations
• patients willing to sign an IRB approved informed consent form
• English fluency (printed instructions are provided in English only)
• varus arthropathy
• osteoarthritis
• ASA less than or equal to 3
• home/cell phone access
• adult to accompany patient home post-operatively and to stay with patient for a minimum period of 1-2 days

You may not qualify if:

• patients with inflammatory arthritis
• patients with a BMI greater than 40 or less than 18
• patients who are skeletally immature
• patient with an active infection or suspected latent infection in or about the joint
• bone stock that is inadequate for support or fixation of the prosthesis
• hardware precluding intramedullary instrumentation
• prior osteotomies of the femur or tibia
• patients living greater than 1.5 hours from the hospital
• patients without access to caregivers, or unable to go to their home after surgery
• cognitive or neuromotor conditions
• patient has significant pain management issues
• patient/family history of anaesthesia related complications (e.g. malignant hypothermia, pseudocholinesterase deficiency, airway difficulties, obstructive sleep apnea)
• significant psycho/social issues that would prevent the patient from managing at home safely

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Brent A Lanting, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not be told which group they have been assigned to until they have reached the final follow-up visit for the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Model Details: Participants will be randomized to undergo their surgery through either the quadriceps-sparing mid-vastus approach or the medial para-patellar approach and with or without a tourniquet. We will stratify based on which type of analgesia will be used post-surgery, either an adductor canal block or local infiltration.

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 16, 2017
• Study Start: July 11, 2017
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)