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

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

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?

Study Overview

• Status: Completed
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Device: THA Corail PinnacleCoC28; Device: THA Corail DeltaMotion36; Device: THA Corail DeltaMotion40

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40136
      • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: THA28; THA Corail PinnacleCoC28	Device: THA Corail PinnacleCoC28; Uncemented THA with Corail stem and Pinnacle acetabular cup with CoC 28 mm head
Active Comparator: THA36; THA Corail DeltaMotion36	Device: THA Corail DeltaMotion36; Uncemented THA with Corail stem and DeltaMotion acetabular cup with 36 mm head
Active Comparator: THA40; THA Corail DeltaMotion40	Device: THA Corail DeltaMotion40; Uncemented THA with Corail stem and DeltaMotion acetabular cup with 40 mm head

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants and Hip Joint Positions with the Occurrence of Implant Impingement	Three-dimension videofluoroscopy is used to calculate prosthesis component relative pose, and to estimate minimum distance at the areas of risk of impingement	12 months
Number of Participants with Functional Deficits at the Hip Joint as Measured by Gait Analysis	Three-dimension kinematics and kinetics of the trunk, pelvis and lower limb joints is used during level walking and other motor tasks, as well as for the single exercises of hip joint extreme motion analyzed in videofluoroscopy, to assess thoroughly those patients with and without impingement.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion of the operated hip versus contralateral non-operated hip	Standard clinical range of motion at the two hips	12 months
Correlations between prosthetic head diameter and hip functional scores	The effect of prosthetic head diameter and any correlation to hip functional scores validated and commonly used in the Literature	12 months
Standard Clinical Hip Scores	Outcomes: Harris Hip Score, Oxford Hip Score, WOMAC, Forgotten Joint score and UCLA activity score will be assessed and recorded pre-operatively and post-operatively at one year after surgery.	pre-op, and 12 months
X-ray measurements	Radiographic assessment will also be performed at one year after surgery to assess implant position and osteointegration	12 months

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Collaborators: DePuy International
• Investigators: Principal Investigator: Sandro Giannini, MD, Prof, Istituto Ortopedico Rizzoli

Publications and helpful links

Helpful Links

• Istituto Ortopedico Rizzoli
• IOR, Movement Analysis Laboratory

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): December 21, 2017

Study Registration Dates

• First Submitted: January 22, 2014
• First Submitted That Met QC Criteria: January 24, 2014
• First Posted (Estimate): January 28, 2014

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Gait analysis; Range of motion; Secondary; Functional assessment; Femoroacetabular impingement; 3D videofluoroscopy; Neck-cup impingement; Head-neck ratio; Hip scores; Cup size; Unilateral Primary
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Parasympathomimetics; Tacrine
• Other Study ID Numbers: IORDePuyD57613