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RecruitingNCT06258369COXAMUpdated Sep 19, 2024

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

An interventional study of Patients with primary coxarthrosis (any stage). and Patients with primary coxarthrosis (any stage) and operated with Total Hip Prosthesis (THP). in Primary; Coxarthrosis, sponsored by Lille Catholic University. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Lille Catholic University · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Primary; Coxarthrosis

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Keywords

  • Coxarthrosis
  • Hip
  • Arthroplasty
  • Gait initiation
03

In context

Osteoarthritis, Hip

641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.

This study's planned enrollment of 100 is above the median of 90 across 457 interventional studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Lille Catholic University is the lead sponsor of 112 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Patients with primary coxarthrosis (any stage).

    Other: Patients with primary coxarthrosis (any stage).

  • Experimental
    Patients with primary coxarthrosis (any stage) and operated with Total Hip prosthesis (THP).

    Other: Patients with primary coxarthrosis (any stage) and operated with Total Hip Prosthesis (THP).

  • Experimental
    Patients with primary coxarthrosis (any stage) and operated with RTH (Hip resurfacing).

    Other: Patients with primary coxarthrosis (any stage) and operated with RTH (Hip resurfacing).

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).

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What researchers measure

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

    The 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

    Time frame: 6 Months

  10. HHS (Harris Hip Score)

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

    Time frame: 6 months

  11. PMA (Postel Merle d'Aubigné) score

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

    Time frame: 6 months

  12. Devane score

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

    Time frame: 6 months

  13. 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)

    Time frame: 6 months

  14. 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.

    Time frame: 6 months

  15. 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

    Time frame: 6 months

  16. Sacral slope angle

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

    Time frame: 6 months

  17. 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.

    Time frame: 6 months

07

Study locations

1 of 2 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06258369
Responsible party
Sponsor
First posted
Feb 14, 2024
Start date
Feb 19, 2024
Primary completion
Aug 19, 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 19, 2024

Study contacts

Marie-Paule LEBITASY
Contact
urm@ghicl.net
+33 3 20 22 52 69
William's VAN DEN BERGHE
Contact
VanDenBerghe.Williams@ghicl.net
+33 3 20 22 57 31
Pierre MARTINOT, MD
study director · Hôpital Saint Philibert, GHICL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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