NCT02047292

Dynamic ROM Via Gait Analysis and 3D Fluoroscopy in THA With Different Head Diameters

Dynamic Range of Motion (ROM) Assessment Using Gait Analysis and Three-dimensional Fluoroscopy in Patients Treated by Total Hip Arthroplasty (THA) With Different Head Diameters

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 35 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Pain and reduced function are the most common symptoms of coxarthritis. Pain relief and normal range of motion (ROM) restoration are the objectives of a Total Hip Arthroplasty (THA) procedure. It is recognized that increased head-neck ratio results in increased ROM due to the fact that prosthetic impingement between neck and acetabular liner occurs with wider arcs of motion. This head-neck ratio has been investigated extensively only in vitro (on cadavers or sawbones) or using mathematical modeling in computer simulations. These studies are limited by the lack of soft tissues and muscle activations in the models. This study will clinically assess the effect of prosthetic head diameter on patient capability of performing movements which require extreme arcs of motion of the hip joint. Therefore, the research questions are: * What role do soft tissues play in limiting ROM? * Can prosthetic impingement really occur in a well positioned THA? * Can a bigger head diameter alone reduce the risk of impingement?

Detailed description

This will be a prospective comparative randomized double-blind Study (both patient and the clinical engineer performing the gait analysis will be blind with respect to the prosthetic head diameter implanted). Patient recruitment will last 12 months and the Study will have a follow-up period of 12 months. A total number of 45 patients will be recruited. Patients will be randomly allocated into three groups: the first group will undergo THA with a 28mm diameter head (Pinnacle Acetabular System, with a ceramic on ceramic - CoC - bearing), in the second group THA will be performed using a 36 mm diameter head (DeltaMotion), finally patients in the third group will undergo THA with a 40 mm diameter head (DeltaMotion). Patients will be operated by three surgeons of the same hospital according to the same surgical procedure and using the same direct lateral approach. All patients will receive a Corail stem and will follow the same rehabilitation program. * Primary endpoint: Gait analysis and fluoroscopy will provide quantitative information of prosthesis in vivo performance, e.g. what is the arc (degrees) of active or passive motion when prosthetic impingement occurs? * Secondary endpoint(s): these analyses will also allow to: 1) assess ROM of the operated hip versus contralateral non operated hip and the effect of prosthetic head diameter and any correlation to hip functional scores validated and commonly used in the Literature; 2) set reproducible criteria for in vivo fluoroscopic analysis of ROM in THA patients.

Conditions

• Hip Osteoarthritis

Interventions

Type	Name	Description
DEVICE	THA Corail PinnacleCoC28	Uncemented THA with Corail stem and Pinnacle acetabular cup with CoC 28 mm head
DEVICE	THA Corail DeltaMotion36	Uncemented THA with Corail stem and DeltaMotion acetabular cup with 36 mm head
DEVICE	THA Corail DeltaMotion40	Uncemented THA with Corail stem and DeltaMotion acetabular cup with 40 mm head

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-02-01
• Completion: 2017-12-21
• First posted: 2014-01-28
• Last updated: 2020-02-17

Locations

1 site across 1 country: Italy