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NCT Number: NCT06258369

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Lille, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Primary outcomes

  1. Amplitude degree of lower limbs articulations

    Time frame: 6 months

  2. Dynamics of limbs joint torques during walking initiation measured in Nm/kg

    Time frame: 6 months

Secondary outcomes

  1. Step length during gait initiation

    Time frame: 6 months

  2. Step width during gait initiation

    Time frame: 6 months

  3. Duration of first step during gait initiation

    Time frame: 6 months

  4. Duration of anticipatory postural adjustment phase during gait initiation

    Time frame: 6 months

  5. Duration of execution phase during gait initiation

    Time frame: 6 months

  6. Measurement of the trajectory during gait initiation

    Time frame: 6 months

  7. Measurement of the speed during gait initiation

    Time frame: 6 months

  8. Measurement of the amplitude of retreat of the center of pressure during gait initiation

    Time frame: 6 months

  9. Severity of coxarthrosis according to the Tönnis classification

    Time frame: 6 Months

    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
  10. HHS (Harris Hip Score)

    Time frame: 6 months

    The functional score consists of 10 items out of 100 points (best score = 100 points) assessing function, pain and mobility

  11. PMA (Postel Merle d'Aubigné) score

    Time frame: 6 months

    Score on 3 items (pain, mobility and walking) rated on 18 points (18 = excellent results, 0 = worst result)

  12. Devane score

    Time frame: 6 months

    Activity score with 5 possibilities (1 = sedentary work and 5 = power work, competitive sport)

  13. UCLA (University of California Los Angeles) score

    Time frame: 6 months

    Activity score comprising 10 possibilities and assessing the intensity of physical activity (1= inactive or dependent patient, 10 = regular practice of high-impact sports)

  14. Vellas unipodal weight-bearing test

    Time frame: 6 months

    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.

  15. Pelvic incidence

    Time frame: 6 months

    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

  16. Sacral slope angle

    Time frame: 6 months

    Spatial orientation of the pelvis in the sagittal plane is assessed by the sacral slope

  17. Pelvic tilt angle

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Paule LEBITASY

CONTACT

[email protected]

+33 3 20 22 52 69

William's VAN DEN BERGHE

CONTACT

[email protected]

+33 3 20 22 57 31

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study 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

Acronym: COXAM

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 14, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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