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| Name | Class |
|---|---|
| DePuy International | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THA28 | Active Comparator | THA Corail PinnacleCoC28 |
|
| THA36 | Active Comparator | THA Corail DeltaMotion36 |
|
| THA40 | Active Comparator | THA Corail DeltaMotion40 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THA Corail PinnacleCoC28 | Device | Uncemented THA with Corail stem and Pinnacle acetabular cup with CoC 28 mm head |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandro Giannini, MD, Prof | Istituto Ortopedico Rizzoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | BO | 40136 | Italy |
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| Label | URL |
|---|---|
| Istituto Ortopedico Rizzoli | View source |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D057925 | Femoracetabular Impingement |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| THA Corail DeltaMotion36 | Device | Uncemented THA with Corail stem and DeltaMotion acetabular cup with 36 mm head |
|
| THA Corail DeltaMotion40 | Device | Uncemented THA with Corail stem and DeltaMotion acetabular cup with 40 mm head |
|
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 |
| D012216 |
| Rheumatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |