Influence of Femoral Head Size During Total Hip Arthroplasty on Gait

NCT04521842 | Completed

• 1 other identifier: WarsawMU/Head
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Total hip replacement (THR) is being considered as one of the most effective medical procedures. Since its introduction, there was a worldwide debate over proper implant selection in terms of size, bearing type and shape. The diameter of used femoral heads components grew throughout the years - from 22 mm in the 1960s to 32 mm in the 2000s, which is the most commonly used size nowadays. In recent years there was a visible use of large femoral heads (\>=36mm) in several registers. In the USA there was a significant grow in use of this heads rising from 1% in early 200s to even 58% in 2009. There is a strong evidence data and many researchers concerning range of movement, risk of dislocation, functional results, pain and prosthesis wear depending of femoral head size. In terms of gait characteristics there are several deviations reported concerning both patients with hip osteoarthritis (OA) and following THR. There is a lack of literature concerning influence of used implants on gait parameters and whether this goal of the surgery can be achieved. The aim of this study was to assess potential differences of lower limb biomechanics during gait in patients following total hip replacement surgery depending on femoral head diameter and compare them to the normal gait of healthy volunteers. As a secondary outcome authors wanted to inspect correlation between gait parameters and patient-reported outcome.

Conditions

Osteoarthritis, Hip; Hip Arthritis; Gait, Frontal

Keywords

osteoarthritis; hip; gait; walk; biomechanics

Outcome Measures

Primary Outcomes (8)

• Time of swing phase

  Change from baseline part of swing phase time during gait, measured in percentage

  at least 3,5 years after surgery

• Time of stance phase

  Change from baseline part of stance phase time during gait, measured in percentage

  at least 3,5 years after surgery

• Time of double-stance phase

  Change from baseline part of double-stance phase time during gait, measured in percentage

  at least 3,5 years after surgery

• Stride length

  Change from baseline length of stride during gait, measured in meters

  at least 3,5 years after surgery

• Cadence

  Change from baseline number of strides per minute of walking

  at least 3,5 years after surgery

• Mean gait velocity

  Change from baseline mean values of gait speed, measured in meters per second

  at least 3,5 years after surgery

• Range of maximal hip extension for both limbs during ending part of mid-stance phase

  Change from baseline range of maximal hip extension for both limbs during ending part of mid-stance phase, measured in degrees

  at least 3,5 years after surgery

• Range of pelvic drop in frontal plane on the opposite site of the bearing limb

  Change from baseline range of pelvic drop in frontal plane on the opposite site of the bearing limb, measured in degrees

  at least 3,5 years after surgery

Study Arms (2)

Standard size femoral head implant

PLACEBO COMPARATOR

Participants qualified to undergo total hip replacement who will receive standard femoral head size implant

Procedure: Total hip replacement

Large size femoral head

ACTIVE COMPARATOR

Participants qualified to undergo total hip replacement who will receive large femoral head size implant

Procedure: Total hip replacement

Interventions

Total hip replacement PROCEDURE

Total hip replacement in treatment of end-stage osteoarthritis

Large size femoral head; Standard size femoral head implant

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \<35
• Ability to walk for 10 meters
• years of age
• Bilateral THR

You may not qualify if:

• Revision surgeries before and after THR
• Any other lower limbs surgeries
• Secondary OA
• Neurological disorders
• Cardiac disorders
• Severly impaired balance
• Severe dizziness

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Gait Disorders, Neurologic; Osteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Bartosz M. Maciąg, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients qualified to undergo total hip arthroplasty due to the end-stage osteoarthritis will be randomly allocated to receive either standard femoral head size implants nor large ones. Pre- and postoperatively they will undergo gait analysis. To avoid risk of bias assessor will be blinded in terms of used implants in every participants case.

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 21, 2020
• Study Start: January 1, 2016
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 14, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.
• Access Criteria: The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.

Locations

PL (1)