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Gait Initiation and Transition From Double to Single Support in Patients With Unilateral Primary Coxarthrosis

Gait Initiation and Transition From Double to Single Support in Patients With Unilateral Primary Coxarthrosis Who Have Not Undergone Surgery and Before/After Arthroplasty

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06258369
Acronym
COXAM
Enrollment
100
Registered
2024-02-14
Start date
2024-02-19
Completion date
2027-09-30
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary; Coxarthrosis

Keywords

Coxarthrosis, Hip, Arthroplasty, Gait initiation

Brief 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. 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).

Interventions

OTHERPatients 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.

OTHERPatients 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).

OTHERPatients 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).

Sponsors

Lille Catholic University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention 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)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frame
Amplitude degree of lower limbs articulations6 months
Dynamics of limbs joint torques during walking initiation measured in Nm/kg6 months

Secondary

MeasureTime frameDescription
Step width during gait initiation6 months
Duration of first step during gait initiation6 months
Duration of anticipatory postural adjustment phase during gait initiation6 months
Duration of execution phase during gait initiation6 months
Measurement of the trajectory during gait initiation6 months
Measurement of the amplitude of retreat of the center of pressure during gait initiation6 months
Severity of coxarthrosis according to the Tönnis classification6 MonthsThe severity of coxarthrosis is assessed on radiographs according to the Tönnis classification: Grade Radiographic features 0 - No signs of osteoarthritis 1. \- Slight narrowing of joint space * Slight lipping at joint margin * Slight sclerosis of the femoral head or acetabulum 2. \- Small cysts in the femoral head or acetabulum * Increasing narrowing of joint space * Moderate loss of sphericity of the femoral head 3. \- Large cysts * Severe narrowing or obliteration of joint space * Severe deformity of the femoral head * Avascular necrosis
Measurement of the speed during gait initiation6 months
PMA (Postel Merle d'Aubigné) score6 monthsScore on 3 items (pain, mobility and walking) rated on 18 points (18 = excellent results, 0 = worst result)
Devane score6 monthsActivity score with 5 possibilities (1 = sedentary work and 5 = power work, competitive sport)
UCLA (University of California Los Angeles) score6 monthsActivity score comprising 10 possibilities and assessing the intensity of physical activity (1= inactive or dependent patient, 10 = regular practice of high-impact sports)
Vellas unipodal weight-bearing test6 monthsThis 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.
Pelvic incidence6 monthsPelvic 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
Sacral slope angle6 monthsSpatial orientation of the pelvis in the sagittal plane is assessed by the sacral slope
Pelvic tilt angle6 monthsPelvic 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.
HHS (Harris Hip Score)6 monthsThe functional score consists of 10 items out of 100 points (best score = 100 points) assessing function, pain and mobility
Step length during gait initiation6 months

Countries

France

Contacts

Primary ContactMarie-Paule LEBITASY
urm@ghicl.net+33 3 20 22 52 69
Backup ContactWilliam's VAN DEN BERGHE
VanDenBerghe.Williams@ghicl.net+33 3 20 22 57 31

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026