Primary; CoxarthrosisCOXAMNCT06258369
Gait Initiation and Transition From Double to Single Support in Patients With Unilateral Primary Coxarthrosis
A study testing Patients with primary coxarthrosis (any stage)., Patients with primary coxarthrosis (any stage) and operated with Total Hip Prosthesis (THP). and Patients with primary coxarthrosis (any stage) and operated with RTH (Hip resurfacing). in people with Primary; Coxarthrosis, run by Lille Catholic University at 2 sites in France.
Trial summary
The study consists to evaluate the impact of prosthetic surgery (PTH and RTH) on kinematic and dynamic parameters (joint torques) of the lower limbs during gait initiation in patients with primary coxarthrosis. Patients included in the study will undergo a three-dimensional gait analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary; Coxarthrosis
- What is being tested?
- Patients with primary coxarthrosis (any stage)., Patients with primary coxarthrosis (any stage) and operated with Total Hip Prosthesis (THP). and Patients with primary coxarthrosis (any stage) and operated with RTH (Hip resurfacing).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Feb 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18 and over
- With primary coxarthrosis (any stage)
- Consulting in the orthopedic departments of participating centers in anticipation of hip surgery (PTH/RTH), or for advice only.
- Written consent signed by the patient
- Affiliation with a social security scheme
Who cannot join
- Disabling orthopaedic conditions:
- Symptomatic contralateral hip/knee disease Symptomatic gonarthrosis or homolateral total knee prosthesis History of surgery on the affected hip History of fracture of the lower limb in the past year History of lower limb sprain in the last 3 months Neurological or degenerative disease
- Pregnant or breast-feeding
- Adults under guardianship, curatorship or safeguard of justice
- Cognitive impairment making it impossible to understand the protocol
- Approach other than Moore posterolateral (for PTH and RTH groups)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
CHU de Lille
Lille, 59000
Julien GIRARD, Julien.GIRARD@chu-lille.fr
Julien GIRARD
- Recruiting
Hôpital Saint-Philibert (GHICL)
Lomme, 59462
Pierre MARTINOT, MD, Martinot.Pierre@ghicl.net
Pierre MARTINOT, MD
About this study
Official title: Gait Initiation and Transition From Double to Single Support in Patients With Unilateral Primary Coxarthrosis Who Have Not Undergone Surgery and Before/After Arthroplasty
The study consists to evaluate the impact of prosthetic surgery (PTH and RTH) on kinematic and dynamic parameters (joint torques) of the lower limbs during gait initiation in patients with primary coxarthrosis.
Patients included in the study will undergo a three-dimensional gait analysis. Dynamic gait analysis is multidimensional, measuring kinematic parameters (joint amplitudes: ankles, knees, hips, etc.) and dynamic parameters (assessment of joint torque from ankle, knee, hip to lower limb during gait initiation).
- Conditions
- Primary; Coxarthrosis
- Being tested
- Patients with primary coxarthrosis (any stage)., Patients with primary coxarthrosis (any stage) and operated with Total Hip Prosthesis (THP)., Patients with primary coxarthrosis (any stage) and operated with RTH (Hip resurfacing).
- Keywords
- Coxarthrosis, Hip, Arthroplasty, Gait initiation
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with primary coxarthrosis (any stage).Other
Patients who do not undergo surgery will be called specifically for the study to attend a consultation dedicated to gait assessment.
Patients with primary coxarthrosis (any stage) and operated with Total Hip Prosthesis (THP).Other
Patients scheduled for THP (Total Hip Prosthesis) will be seen at the consultation the day before surgery, in the same hospital as the THP, or at an existing dedicated consultation scheduled for all THP patients. During these scheduled visits, they will be received in the gait analysis laboratory for a gait assessment (V1). Patients will be seen again at 6 months post-operatively for a second gait assessment (V2).
Patients with primary coxarthrosis (any stage) and operated with RTH (Hip resurfacing).Other
Patients scheduled for RTH (Hip Resurfacing) will be seen at the consultation the day before surgery, in the same hospital as the RTH, or at an existing dedicated consultation scheduled for all RTH patients. During these scheduled visits, they will be received in the gait analysis laboratory for a gait assessment (V1). Patients will be seen again at 6 months post-operatively for a second gait assessment (V2).
| Study group | Role | What they receive |
|---|---|---|
| Patients with primary coxarthrosis (any stage). | Other | Not described Receives: Other: Patients with primary coxarthrosis (any stage). |
| Patients with primary coxarthrosis (any stage) and operated with Total Hip prosthesis (THP). | Experimental | Not described Receives: Other: Patients with primary coxarthrosis (any stage) and operated with Total Hip Prosthesis (THP). |
| Patients with primary coxarthrosis (any stage) and operated with RTH (Hip resurfacing). | Experimental | Not described Receives: Other: Patients with primary coxarthrosis (any stage) and operated with RTH (Hip resurfacing). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude degree of lower limbs articulations
Measured: 6 months
Dynamics of limbs joint torques during walking initiation measured in Nm/kg
Measured: 6 months
Secondary outcomes (17)
Step length during gait initiation
Measured: 6 months
Step width during gait initiation
Measured: 6 months
Duration of first step during gait initiation
Measured: 6 months
Duration of anticipatory postural adjustment phase during gait initiation
Measured: 6 months
Duration of execution phase during gait initiation
Measured: 6 months
Measurement of the trajectory during gait initiation
Measured: 6 months
Measurement of the speed during gait initiation
Measured: 6 months
Measurement of the amplitude of retreat of the center of pressure during gait initiation
Measured: 6 months
Severity of coxarthrosis according to the Tönnis classification
The severity of coxarthrosis is assessed on radiographs according to the Tönnis classification:
Grade Radiographic features 0 - No signs of osteoarthritis
- - Slight narrowing of joint space
- Slight lipping at joint margin
- Slight sclerosis of the femoral head or acetabulum
- - Small cysts in the femoral head or acetabulum
- Increasing narrowing of joint space
- Moderate loss of sphericity of the femoral head
- - Large cysts
- Severe narrowing or obliteration of joint space
- Severe deformity of the femoral head
- Avascular necrosis
Measured: 6 Months
HHS (Harris Hip Score)
The functional score consists of 10 items out of 100 points (best score = 100 points) assessing function, pain and mobility
Measured: 6 months
PMA (Postel Merle d'Aubigné) score
Score on 3 items (pain, mobility and walking) rated on 18 points (18 = excellent results, 0 = worst result)
Measured: 6 months
Devane score
Activity score with 5 possibilities (1 = sedentary work and 5 = power work, competitive sport)
Measured: 6 months
UCLA (University of California Los Angeles) score
Activity score comprising 10 possibilities and assessing the intensity of physical activity (1= inactive or dependent patient, 10 = regular practice of high-impact sports)
Measured: 6 months
Vellas unipodal weight-bearing test
This test consists in asking the patient to balance for as long as possible. A time of more than 30 seconds indicated a very low risk of falls. A time of less than 5 seconds indicates a very high risk of falls.
Measured: 6 months
Pelvic incidence
Pelvic incidence is a constant morphologic parameter that describes the "pelvic size" based on the angular relation between femoral heads and sacral plate for any given person
Measured: 6 months
Sacral slope angle
Spatial orientation of the pelvis in the sagittal plane is assessed by the sacral slope
Measured: 6 months
Pelvic tilt angle
Pelvic tilt is a position-dependent parameter defined as the angle created by a line running from the sacral endplate midpoint to the center of the bifemoral heads and the vertical axis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start19 Feb 2024
- Primary completion19 Aug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary; CoxarthrosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with coxarthrosis (any stage) without surgery Patients with coxarthrosis (any stage) with THP (Total Hip replacement) Patients with coxarthrosis (any stage) with RHT (Hip resurfacing)
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre MARTINOT, MD, Study director, Hôpital Saint Philibert, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258369
- Sponsor's protocol ID
- RC-P00122
- Acronym
- COXAM
- Status last verified
- Sep 2024
- First submitted
- 6 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Initiation and Transition From Double to Single Support in Patients With Unilateral Primary Coxarthrosis Who Have Not Undergone Surgery and Before/After Arthroplasty
- ClinicalTrials.gov ID
- NCT06258369
- Acronym / sponsor ID
- COXAM / RC-P00122
- Conditions
- Primary; Coxarthrosis
- Keywords
- Coxarthrosis, Hip, Arthroplasty, Gait initiation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 19 Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 14 Feb 2024 (actual)
- 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.
The study consists to evaluate the impact of prosthetic surgery (PTH and RTH) on kinematic and dynamic parameters (joint torques) of the lower limbs during gait initiation in patients with primary coxarthrosis.
Patients included in the study will undergo a three-dimensional gait analysis. Dynamic gait analysis is multidimensional, measuring kinematic parameters (joint amplitudes: ankles, knees, hips, etc.) and dynamic parameters (assessment of joint torque from ankle, knee, hip to lower limb during gait initiation).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients with coxarthrosis (any stage) without surgery Patients with coxarthrosis (any stage) with THP (Total Hip replacement) Patients with coxarthrosis (any stage) with RHT (Hip resurfacing)
| Arm | Type | Receives |
|---|---|---|
| Patients with primary coxarthrosis (any stage). | Other | Other: Patients with primary coxarthrosis (any stage). |
| Patients with primary coxarthrosis (any stage) and operated with Total Hip prosthesis (THP). | Experimental | Other: Patients with primary coxarthrosis (any stage) and operated with Total Hip Prosthesis (THP). |
| Patients with primary coxarthrosis (any stage) and operated with RTH (Hip resurfacing). | Experimental | Other: Patients with primary coxarthrosis (any stage) and operated with RTH (Hip resurfacing). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women aged 18 and over
- With primary coxarthrosis (any stage)
- Consulting in the orthopedic departments of participating centers in anticipation of hip surgery (PTH/RTH), or for advice only.
- Written consent signed by the patient
- Affiliation with a social security scheme
Key exclusion criteria (6 listed)
- Disabling orthopaedic conditions:
- Symptomatic contralateral hip/knee disease Symptomatic gonarthrosis or homolateral total knee prosthesis History of surgery on the affected hip History of fracture of the lower limb in the past year History of lower limb sprain in the last 3 months Neurological or degenerative disease
- Pregnant or breast-feeding
- Adults under guardianship, curatorship or safeguard of justice
- Cognitive impairment making it impossible to understand the protocol
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 |
|---|---|---|
| Patients with primary coxarthrosis (any stage).Patients who do not undergo surgery will be called specifically for the study to attend a consultation dedicated to gait assessment. | Other | Patients with primary coxarthrosis (any stage). |
| Patients with primary coxarthrosis (any stage) and operated with Total Hip Prosthesis (THP).Patients scheduled for THP (Total Hip Prosthesis) will be seen at the consultation the day before surgery, in the same hospital as the THP, or at an existing dedicated consultation scheduled for all THP patients. During these scheduled visits, they will be received in the gait analysis laboratory for a gait assessment (V1). Patients will be seen again at 6 months post-operatively for a second gait assessment (V2). | Other | Patients with primary coxarthrosis (any stage) and operated with Total Hip prosthesis (THP). |
| Patients with primary coxarthrosis (any stage) and operated with RTH (Hip resurfacing).Patients scheduled for RTH (Hip Resurfacing) will be seen at the consultation the day before surgery, in the same hospital as the RTH, or at an existing dedicated consultation scheduled for all RTH patients. During these scheduled visits, they will be received in the gait analysis laboratory for a gait assessment (V1). Patients will be seen again at 6 months post-operatively for a second gait assessment (V2). | Other | Patients with primary coxarthrosis (any stage) and operated with RTH (Hip resurfacing). |
Primary outcome
Amplitude degree of lower limbs articulations
Time frame: 6 months
Dynamics of limbs joint torques during walking initiation measured in Nm/kg
Time frame: 6 months
17 secondary outcomes
Step length during gait initiation
Time frame: 6 months
Step width during gait initiation
Time frame: 6 months
Duration of first step during gait initiation
Time frame: 6 months
Duration of anticipatory postural adjustment phase during gait initiation
Time frame: 6 months
Duration of execution phase during gait initiation
Time frame: 6 months
Measurement of the trajectory during gait initiation
Time frame: 6 months
Measurement of the speed during gait initiation
Time frame: 6 months
Measurement of the amplitude of retreat of the center of pressure during gait initiation
Time frame: 6 months
Severity of coxarthrosis according to the Tönnis classification
Time frame: 6 Months
HHS (Harris Hip Score)
Time frame: 6 months
PMA (Postel Merle d'Aubigné) score
Time frame: 6 months
Devane score
Time frame: 6 months
UCLA (University of California Los Angeles) score
Time frame: 6 months
Vellas unipodal weight-bearing test
Time frame: 6 months
Pelvic incidence
Time frame: 6 months
Sacral slope angle
Time frame: 6 months
Pelvic tilt angle
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Pierre MARTINOT, MD study director
Hôpital Saint Philibert, GHICL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients with primary coxarthrosis (any stage)., Patients with primary coxarthrosis (any stage) and operated with Total Hip Prosthesis (THP). and Patients with primary coxarthrosis (any stage) and operated with RTH (Hip resurfacing). in people with Primary; Coxarthrosis, run by Lille Catholic University at 2 sites in France.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Paule LEBITASY (+33 3 20 22 52 69, urm@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude degree of lower limbs articulations (time frame: 6 months). The study lists 2 primary outcomes in all. 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 19 Sep 2024.