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

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).

Study Overview

• Status: Recruiting
• Conditions: Primary; Coxarthrosis
• Intervention / Treatment: Other: Patients with primary coxarthrosis (any stage).; Other: Patients with primary coxarthrosis (any stage) and operated with Total Hip Prosthesis (THP).; Other: Patients with primary coxarthrosis (any stage) and operated with RTH (Hip resurfacing).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Paule LEBITASY; Phone Number: +33 3 20 22 52 69; Email: urm@ghicl.net
• Study Contact Backup: Name: William's VAN DEN BERGHE; Phone Number: +33 3 20 22 57 31; Email: VanDenBerghe.Williams@ghicl.net

Study Locations

• France
  • Lille, France, 59000
    • Not yet recruiting
    • CHU de LILLE
    • Contact: Julien GIRARD; Email: Julien.GIRARD@chu-lille.fr
    • Principal Investigator: Julien GIRARD
  • Lomme, France, 59462
    • Recruiting
    • Hôpital Saint-Philibert (GHICL)
    • Contact: Pierre MARTINOT, MD; Email: Martinot.Pierre@ghicl.net
    • Principal Investigator: Pierre MARTINOT, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with primary coxarthrosis (any stage).	Other: 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.
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).; 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).
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).; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amplitude degree of lower limbs articulations	6 months
Dynamics of limbs joint torques during walking initiation measured in Nm/kg	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step length during gait initiation		6 months
Step width during gait initiation		6 months
Duration of first step during gait initiation		6 months
Duration of anticipatory postural adjustment phase during gait initiation		6 months
Duration of execution phase during gait initiation		6 months
Measurement of the trajectory during gait initiation		6 months
Measurement of the speed during gait initiation		6 months
Measurement of the amplitude of retreat of the center of pressure during gait initiation		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 spaceSlight lipping at joint marginSlight sclerosis of the femoral head or acetabulum; - Small cysts in the femoral head or acetabulumIncreasing narrowing of joint spaceModerate loss of sphericity of the femoral head; - Large cystsSevere narrowing or obliteration of joint spaceSevere deformity of the femoral headAvascular necrosis	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	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)	6 months
Devane score	Activity score with 5 possibilities (1 = sedentary work and 5 = power work, competitive sport)	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)	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.	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	6 months
Sacral slope angle	Spatial orientation of the pelvis in the sagittal plane is assessed by the sacral slope	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.	6 months

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Study Director: Pierre MARTINOT, MD, Hôpital Saint Philibert, GHICL

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Estimated): August 19, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Arthroplasty; Hip; Coxarthrosis; Gait initiation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: RC-P00122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No