Prospective Study Deltamotion - DAA THA Study

November 16, 2020 updated by: Universitaire Ziekenhuizen KU Leuven
  1. Introduction Few gait analytical data are available concerning the Direct Anterior Approach (DAA) in total hip arthroplasty (THA). All the studies have focused on immediate post-operative recovery. These studies have in general some important shortcomings in order to accurately evaluate the biomechanics of the replaced hip joint. None of the published reports have reported on consecutive intervals of pre-op - 6w - 3m - 6m - 12m. This is of interest as we know that recovery with other approaches takes >1 year. It might be that the DAA approach leads to normal gait patterns at 3m or 6m and that these patterns do not differ from the normal pattern or at >1y post-op. None of the reports utilized out-of-plane movements such as coming down or up stairs or squads. Utilizing trunk markers is frequently not done but it is important to evaluate the centre of mass position during gait. Very few studies utilize kinetic data, which are important in order to thoroughly evaluate the biomechanics and loading of the hip. And maybe most importantly, the biomechanical effect of the diameter of the articulating surface on gait parameters following the DAA has never been evaluated.

    One of the most important advantages of the DAA is the muscle sparing aspect and the presumption that the femoral anatomy and biomechanics can be more accurately and precisely restored. If the diameter of the articulating surface has then also been reconstructed to the almost anatomical diameter, we can assume that this should be the most optimal reconstruction of the hip joint currently available. This could lead to early return to normal gait, to optimal joint loading and a minimal amount of stress shielding of the femoral bone.

    The aim of this project is to prospectively analyse the biomechanics of the hip joint of a THA with a Deltamotion articulating surface utilizing the Direct Anterior Approach.

  2. Materials and Methods Hypothesis: The temporo-spatial parameters (velocity, cadence, step length, and stride length) and gait kinematic and kinetic data (external hip and knee muscle moments) are not significantly different between the study and control group at the evaluated time intervals indicating normal or near normal gait patterns in the early post-operative recovery phase.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Estimated inclusion time: 1 July 2011 - 31 December 2013 Cohorts: 20 DAA subjects - 20 control subjects

Assessments:

  • Time interval: pre-op - 3m - 6m - 12m
  • Gait analysis with surface EMG and trunk markers:

    • Unipodal standing: 3 trials Right and 3 trials Left on FP
    • Level walking: 3 trials Right and 3 trials Left on FP
    • Chair rise: 3 trials, both legs on FP
    • Stair ascent: 3 trials Right and 3 trials Left on first FP
    • Stair descent: 3 trials Right and 3 trials Left on first FP
    • Squat: 3 trials, both legs on FP
    • Bipodal squat: 3 trials Right and 3 trials Left on FP
  • Functional scores (HHS, UCLA, HOOS, SF-36)

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Leuven, Belgium, 3000
        • UZ Pellenberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

20 DAA subjects

Description

Inclusion Criteria:

  • Age: 20-75 years
  • BMI: < 30kg/m2
  • Diagnosis: unilateral primary and secondary osteoarthritis treated with the Deltamotion THA with a Corail stem

Exclusion Criteria:

  • Osteoarthritis other joints and low back impairment
  • LLD > 5mm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
20 DAA subjects
20 DAA subjects: THA with a Deltamotion articulating surface utilizing the Direct Anterior Approach
  • Time interval: pre-op - 3m - 6m - 12m
  • Assessment of all subjects:

    • XR
    • Gait analysis with surface EMG and trunk markers:

      • Unipodal standing: 3 trials Right and 3 trials Left on FP
      • Level walking: 3 trials Right and 3 trials Left on FP
      • Chair rise: 3 trials, both legs on FP
      • Stair ascent: 3 trials Right and 3 trials Left on first FP
      • Stair descent: 3 trials Right and 3 trials Left on first FP
      • Squat: 3 trials, both legs on FP
    • Bipodal squat: 3 trials Right and 3 trials Left on FP
  • Functional scores (HHS, UCLA, HOOS, SF-36)
Control group
healthy volunteers
  • Time interval: pre-op - 3m - 6m - 12m
  • Assessment of all subjects:

    • XR
    • Gait analysis with surface EMG and trunk markers:

      • Unipodal standing: 3 trials Right and 3 trials Left on FP
      • Level walking: 3 trials Right and 3 trials Left on FP
      • Chair rise: 3 trials, both legs on FP
      • Stair ascent: 3 trials Right and 3 trials Left on first FP
      • Stair descent: 3 trials Right and 3 trials Left on first FP
      • Squat: 3 trials, both legs on FP
    • Bipodal squat: 3 trials Right and 3 trials Left on FP
  • Functional scores (HHS, UCLA, HOOS, SF-36)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biomechanics
Time Frame: 0.5 year
prospectively analyse the biomechanics of the hip joint of a THA with a Deltamotion articulating surface utilizing the Direct Anterior Approach
0.5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone remodelling
Time Frame: 1 year
assess the femoral bone remodelling around the fully coated Corail stem over the first year post-operatively.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Kristoff Corten, Doctor, UZ Pellenberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

November 7, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (ESTIMATE)

November 17, 2011

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

August 1, 2011

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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