Collared Versus Collarless Femoral Implants for Total Hip Arthroplasty

NCT03558217 | Completed

• 1 other identifier: 109401
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized control trial that will investigate whether a collared hip replacement implant provides greater stability compared to a collarless option. Stability will be measured by implant migration with radiostereometric analysis (RSA) imaging. Secondary objectives will be to compare function, quality of life and cost between the two implant types. We will also compare between two different surgical approaches, the direct anterior and direct lateral.

Conditions

Hip Osteoarthritis; Hip Arthroplasty

Keywords

total hip arthroplasty; collarless femoral implant; collared femoral implant; direct anterior approach; direct lateral approach

Outcome Measures

Primary Outcomes (1)

• Implant Migration

  Movement of the implant measured by radiostereometric imaging analysis.

  2 years

Secondary Outcomes (8)

• Timed-Up-and-Go (TUG) Test

  baseline and 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years

• Activity Level

  baseline and 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years

• University of California, Los Angeles (UCLA) Activity Score

  baseline and 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years

• 12-Item Short Form Health Survey (SF-12)

  baseline and 3 months, 6 months, 1 year and 2 years

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  baseline and 3 months, 6 months, 1 year and 2 years

Study Arms (2)

Collared Femoral Implant

EXPERIMENTAL

Participants will have the Corail collared femoral implant used during their surgery.

Device: Collared Femoral Implant

Collarless Femoral Implant

ACTIVE COMPARATOR

Participants will have the Corail collarless femoral implant used during their surgery.

Device: Collarless Femoral Implant

Interventions

Collared Femoral Implant DEVICE

Corail collared femoral implant for total hip arthroplasty

Collared Femoral Implant

Collarless Femoral Implant DEVICE

Corail collarless femoral implant for total hip arthroplasty

Collarless Femoral Implant

Eligibility Criteria

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

You may qualify if:

• unilateral hip osteoarthritis
• primary total hip arthroplasty

You may not qualify if:

• symptomatic osteoarthritis in the contralateral hip
• bilateral total hip arthroplasty
• revision arthroplasty
• cognitive defects/neuromuscular disorders
• inability to understand English (questionnaires are only provided in English)
• live more than 100km from London, Ontario
• BMI greater than 40

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, N6A 5A5, Canada

Location

Related Publications (1)

• Polus JS, Vasarhelyi EM, Lanting BA, Teeter MG. Acetabular cup fixation with and without screws following primary total hip arthroplasty: migration evaluated by radiostereometric analysis. Hip Int. 2024 Jan;34(1):42-48. doi: 10.1177/11207000231164711. Epub 2023 Apr 5.

  PMID: 37016808 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

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

Study Officials

• Brent A Lanting, MD, FRCSC

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to which group they have been assigned to until the final study visit at which point study personnel will reveal the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Model Details: Participants will be randomized to have either the collared or collarless Corail femoral implant used during surgery and randomization will be stratified by surgical approach (determined by surgeon expertise).

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: June 15, 2018
• Study Start: January 15, 2018
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: February 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)