Influence of Femoral Head Size During Total Hip Arthroplasty on Gait
Condition: Osteoarthritis, Hip; Hip Arthritis; Gait, Frontal
MeSH terms: Osteoarthritis; Osteoarthritis, Hip; Gait Disorders, Neurologic
Study type: Interventional

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.
    

Detailed description: 
      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. It is well-proven that those with
      hip OA have reduced stride length and reduced cadence, reduced gait velocity, and reduced
      joint excursion. Patients after THR walk with lower hip-abduction moments, sagittal-plane
      range of motion. It is believed that it might be a consequence of pain-avoidance mechanism
      developed as an adaptation for joint disease, which is still present after the surgery. What
      is more, there are publications, which underline that lower limb biomechanics during gait do
      not return to normal following THR.

      However there is a lack of literature concerning influence of used implants on gait
      parameters and whether this goal of the surgery can be achieved.

      According to authors best knowledge this study is the first to ever describe potential
      differences in gait parameters between THR performed with standard femoral heads (28-32mm)
      and large ones (>=36mm).

      Aim of the study 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.
    

Intervention name(s): Total hip replacement
Intervention type(s): Procedure
Intervention description(s): Total hip replacement in treatment of end-stage osteoarthritis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteoarthritis; hip; gait; walk; biomechanics