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The purpose of this study is to evaluate the safety and effectiveness of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery.
This study will assess the performance and success rate of the EcoFit Total Hip System. Survivorship and clinical outcomes will help determine implant success 36 months as defined by specific scoring systems and compared to other published data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EcoFit® Total Hip System with implacross® E Polyethylene | Subjects who meet the indications for use for the EcoFit® Total Hip System with implacross® E Polyethylene and are candidates for a primary hip replacement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EcoFit® Total Hip System with implacross® E Polyethylene | Device | The EcoFit® Total Hip System is a primary hip replacement system indicated for patients who are candidates for a primary cementless hip replacement. implacross® E Polyethylene is one of the components in the EcoFit® system. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery | Evaluate the overall survivorship of the devices. Observed product-related complications and revisions are recorded and documented. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the pre to post-op change in the Harris Hip Score | The Harris Hip Score tracks pain, function/gait, performance in functional activities, and range of motion as interpreted by the surgeon. The responses determine a score which can be compared in different intervals. | Pre-op, 6 months, 12 months, 24 months, 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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PIs will recruit from their patient population; patients already intending to undergo a total hip replacement.
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D005264 | Femoral Fractures |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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|
| Evaluate the pre to post-op change in the WOMAC Score |
The Western Ontario McMaster Arthritis Index, a questionnaire completed by the patient, tracks pain, stiffness, and difficulty with daily activities. |
| Pre-op, 6 months, 12 months, 24 months, 36 months |
| Device related complications | Detect any device related complications via the adverse events reporting | Through completion of study, an average of 3.5 years |
| D010003 |
| Osteoarthritis |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |