Clinical trial NCT02047292: Dynamic ROM Via Gait Analysis and 3D Fluoroscopy in THA With Different Head Diameters
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
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
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
Collaborators: name: DePuy International
First posted: 2014-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients with unilateral primary or secondary hip arthrosis indicated for THA;
* Men and female, age between 35 and 55 years old;
* BMI smaller than 30;
* Patients able to understand the protocol and to sign the informed consent.

Exclusion Criteria:

* Child-bearing female;
* Patients with also controlateral hip arthritis;
* Neurological patients, because of possible alteration of neuro-muscular control of the replaced hip;
* Patients treated with joint replacement at any other lower limb articulation

Primary outcomes:
measure: Number of Participants and Hip Joint Positions with the Occurrence of Implant Impingement
timeFrame: 12 months
measure: Number of Participants with Functional Deficits at the Hip Joint as Measured by Gait Analysis
timeFrame: 12 months
Secondary outcomes:
measure: Range of Motion of the operated hip versus contralateral non-operated hip
timeFrame: 12 months
measure: Correlations between prosthetic head diameter and hip functional scores
timeFrame: 12 months
measure: Standard Clinical Hip Scores
timeFrame: pre-op, and 12 months
measure: X-ray measurements
timeFrame: 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: BO
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Sandro Giannini, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: