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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Belgium
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
20 DAA subjects
20 DAA subjects: THA with a Deltamotion articulating surface utilizing the Direct Anterior Approach
Other: Biomechanics
  • 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
Other: Biomechanics
  • 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
DePuy International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • s52629

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.

Clinical Trials on Arthrosis

Clinical Trials on Biomechanics

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings