Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ?

NCT04587440 | Unknown

• 1 other identifier: 29BRC20.0120
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Total hip replacement is one of the most common surgical procedure in France. In 2010, an estimated 147 513 total hip procedures were performed. This number is constantly increasing. Although it is common, it can lead to many complications. The intra-prosthetic luxation is the second one after aseptic loosening. The luxation risk is multifactorial and depends on the relative orientation of femoral et acetabular components. This orientation is influenced by statics and dynamics parameters. So far, the literature shows that only static parameters are considered by surgeons. Thus, in reference to Lewinneck publication, which states that the luxation risk is lower if the cup is oriented with 15° +/- 10° of anteversion and 40°+/- 10° of inclination with respect to the anterior pelvic plan (APP). Defined by the two anterosuperior iliacs spines and pubic symphysis. However, this approach is only static and do not take into account the variations of pelvic plan orientation during everyday life. To consider these variations of pelvic inclination, it is possible to measure the angle between APP and the horizontal (in lying position) or the vertical (in standing position) plan. Several devices allow the measure of pelvic inclination but they all have important limits (EOS radiography, scanner or navigation). A new device has been developed in Brest to measure this inclination in several positions of the daily life.This software has already been tested in healthy volunteers and results demonstrate an excellent accuracy and reproducibility. The goal of this study is to described the dynamic of the pelvic bone thanks to this ultrasound based device, and to assess the amount of variation induced by hip replacement procedures.

Conditions

Coxarthrosis; Primary; Coxarthrosis; Secondary

Outcome Measures

Primary Outcomes (1)

• Variation of the pelvic incidence

  The main evaluation criterion is the variation of the pelvic incidence between pre- and post-operative total hip replacements

  Day 0 - Month 3

Secondary Outcomes (4)

• Analysis of the correlation between the variation in pelvic incidence while sitting, standing and lying down and the implant settings

  Day 0 - Month 3

• Analysis of the correlation between variation in pelvic incidence while sitting, standing and lying down and clinical parameters (Harris hip score)

  Day 0 - Month 3

• Analysis of the correlation between variation in pelvic incidence while sitting, standing and lying down and clinical parameters (EVA)

  Day 0 - Month 3

• Analysis of the correlation between variation in pelvic incidence while sitting, standing and lying down and clinical parameters (Hand-ground distance)

  Day 0 - Month 3

Study Arms (1)

Patient

EXPERIMENTAL

All patients will have a clinical examination before surgery and another 3 months after surgery, each including : * A medical examination * 3 pelvic inclination measurements (1 sitting, 1 lying and 1 standing). These measurements will be done by ultrasound devices. * 2 EOS X-rays (1 standing and 1 sitting) of the lower limbs and spine * Harris hip score * Pain quantification thanks to an EVA scale * hand-ground distance

Other: Pelvic inclination measurement

Interventions

Pelvic inclination measurement OTHER

Ultra-sound based measurements of the pelvic inclination lying, standing and seating position. EOX X-ray in seating position.

Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with primary or secondary hip arthritis, at stage II to III of the radiological classification of Tönnis and for whom total hip replacement is indicated by surgeon.
• Signed consent
• Patient beneficiary of a social security plan

You may not qualify if:

• Patient Under 18
• Patient Under protective measure (guardianship, curatorship) or unable to consent
• Patient requiring revision THR
• Patient with geographic mobility plan before the end of the follow-up
• Symptomatic contralateral hip
• Symptomatic dorsolumbar rachis
• Pelvis or spine surgery planed during the follow-up
• Pregnant or nursing woman

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eric Stindel, PUPH

CONTACT

+33298347275; eric.stindel@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study of the variation of the dynamic of the pelvic bone in pre and post operative of a hip replacement

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 14, 2020
• Study Start: February 2, 2021
• Primary Completion: February 2, 2023
• Study Completion: August 2, 2023
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion.
• Access Criteria: Data access request will be reviewed by the internal committee of Brest University Hospital. Requestor will be required to sign and complete a data access agreement.

Locations

FR (1)