Hip Osteoarthritis Clinical Trial
— DROMDPOfficial 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
Verified date | February 2020 |
Source | Istituto Ortopedico Rizzoli |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
Status | Completed |
Enrollment | 30 |
Est. completion date | December 21, 2017 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Ortopedico Rizzoli | Bologna | BO |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Rizzoli | DePuy International |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Range of Motion of the operated hip versus contralateral non-operated hip | Standard clinical range of motion at the two hips | 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | X-ray measurements | Radiographic assessment will also be performed at one year after surgery to assess implant position and osteointegration | 12 months |
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