Prospective Study Deltamotion - DAA THA Study

NCT01474031 | Terminated

• 1 other identifier: s52629
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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.
2. 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.

Conditions

Arthrosis

Keywords

total hip arthroplasty; biomechanics; direct anterior approach

Outcome Measures

Primary Outcomes (1)

• biomechanics

  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 Outcomes (1)

• bone remodelling

  1 year

Study Arms (2)

20 DAA subjects

20 DAA subjects: THA with a Deltamotion articulating surface utilizing the Direct Anterior Approach

Other: Biomechanics

Control group

healthy volunteers

Other: Biomechanics

Interventions

Biomechanics OTHER

* 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)

20 DAA subjects; Control group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

20 DAA subjects

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• DePuy International: collaborator

Study Sites (1)

UZ Pellenberg

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Biomechanical Phenomena

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Biophysical Phenomena; Physical Phenomena; Mechanical Phenomena

Study Officials

• Kristoff Corten, Doctor

  UZ Pellenberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 17, 2011
• Study Start: October 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 18, 2020

Record last verified: 2011-08

Locations

BE (1)