ArthrosisNCT01474031
Prospective Study Deltamotion - DAA THA Study
An observational study of Arthrosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthrosis
- What is being tested?
- Biomechanics
- How many people
- 29 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2011to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 20 DAA subjects
Who may be able to join
- Age: 20-75 years
- BMI: < 30kg/m2
- Diagnosis: unilateral primary and secondary osteoarthritis treated with the Deltamotion THA with a Corail stem
Who cannot join
- Osteoarthritis other joints and low back impairment
- LLD > 5mm
Trial locations and contacts
1 site in 1 country.
About this study
- 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.
- 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.
Read the 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)
- Conditions
- Arthrosis
- Being tested
- Biomechanics
- Keywords
- total hip arthroplasty, biomechanics, direct anterior approach
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiomechanicsOther
- 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)
| Study group | Role | What they receive |
|---|---|---|
| 20 DAA subjects | 20 DAA subjects: THA with a Deltamotion articulating surface utilizing the Direct Anterior Approach Receives: Other: Biomechanics | |
| Control group | healthy volunteers Receives: Other: Biomechanics |
What is being measured
The primary outcome is the main question the study is designed to answer.
biomechanics
prospectively analyse the biomechanics of the hip joint of a THA with a Deltamotion articulating surface utilizing the Direct Anterior Approach
Measured: 0.5 year
Secondary outcomes (1)
bone remodelling
assess the femoral bone remodelling around the fully coated Corail stem over the first year post-operatively.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: Main investigator has left the department and therefore the study had ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy International
- Responsible party
- Sponsor
- Investigators
- Kristoff Corten, Doctor, Principal investigator, UZ Pellenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474031
- Sponsor's protocol ID
- s52629
- Status last verified
- Aug 2011
- First submitted
- 7 Nov 2011
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Deltamotion - DAA THA Study
- ClinicalTrials.gov ID
- NCT01474031
- Acronym / sponsor ID
- s52629
- Conditions
- Arthrosis
- Keywords
- total hip arthroplasty, biomechanics, direct anterior approach
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Main investigator has left the department and therefore the study had ended
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- DePuy International
- Study start
- Oct 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 DAA subjects | – | Other: Biomechanics20 DAA subjects: THA with a Deltamotion articulating surface utilizing the Direct Anterior Approach |
| Control group | – | Other: Biomechanicshealthy volunteers |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 20 DAA subjects
Key inclusion criteria (3 listed)
- Age: 20-75 years
- BMI: < 30kg/m2
- Diagnosis: unilateral primary and secondary osteoarthritis treated with the Deltamotion THA with a Corail stem
Key exclusion criteria (2 listed)
- Osteoarthritis other joints and low back impairment
- LLD > 5mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | 20 DAA subjects, Control group |
Primary outcome
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
1 secondary outcome
bone remodelling
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Main investigator has left the department and therefore the study had ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
Related trials for Arthrosis
RecruitingObservational study
Treatment Effectiveness in People With axSpA or PsA Starting Treatment With Bimekizumab, Risankizumab, Guselkumab, Upadacitinib, or a TNF Inhibitor
Axial Spondylarthritis (axSpA), Psoriatic Arthritis (PsA)
RecruitingPhase 4
BonE and Joint Infections - Simplifying Treatment in Children Trial
Bone Infection, Septic Arthritis
Not yet recruiting
Study Comparing Osteoarthritis Programs
Osteoarthritis
Recruiting
Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Knee Arthritis, Osteoarthritis
RecruitingObservational study
PsoBest - The German Psoriasis Registry
Psoriasis, Psoriatic-arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristoff Corten, Doctor principal investigator
UZ Pellenberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthrosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Main investigator has left the department and therefore the study had ended). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biomechanics (time frame: 0.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.