Dynamic ROM Via Gait Analysis and 3D Fluoroscopy in THA With Different Head Diameters
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

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.
    

Intervention name(s): THA Corail PinnacleCoC28; THA Corail DeltaMotion36; THA Corail DeltaMotion40
Intervention type(s): Device; Device; Device
Intervention description(s): Uncemented THA with Corail stem and Pinnacle acetabular cup with CoC 28 mm head; Uncemented THA with Corail stem and DeltaMotion acetabular cup with 36 mm head; Uncemented THA with Corail stem and DeltaMotion acetabular cup with 40 mm head
Intervention MeSH terms: Tacrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gait analysis; 3D videofluoroscopy; Femoroacetabular impingement; Neck-cup impingement; Head-neck ratio; Hip scores; Functional assessment; Cup size; Range of motion; Unilateral Primary; Secondary