Prospective Study Deltamotion - DAA THA Study

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Terminated
CT.gov ID
NCT01474031
Collaborator
DePuy International (Industry)
29
1
21
1.4

Study Details

Study Description

Brief Summary

  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.

  1. 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.
Condition or Disease Intervention/Treatment Phase
  • Other: Biomechanics

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 Design

Study Type:
Observational
Actual Enrollment :
29 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Study Deltamotion - DAA THA Study
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

  1. biomechanics [0.5 year]

    prospectively analyse the biomechanics of the hip joint of a THA with a Deltamotion articulating surface utilizing the Direct Anterior Approach

Secondary Outcome Measures

  1. bone remodelling [1 year]

    assess the femoral bone remodelling around the fully coated Corail stem over the first year post-operatively.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Pellenberg Leuven Belgium 3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven
  • DePuy International

Investigators

  • Principal Investigator: Kristoff Corten, Doctor, UZ Pellenberg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01474031
Other Study ID Numbers:
  • s52629
First Posted:
Nov 17, 2011
Last Update Posted:
Nov 18, 2020
Last Verified:
Aug 1, 2011
Keywords provided by Universitaire Ziekenhuizen Leuven
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2020