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Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mpact cup | Quadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MPact Cup | Device | Quadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Harris Hip Scores (HHS) | Assessment of improvement of clinical outcomes following total hip replacement surgery using the Harris Hip Scores | Pre-operative, 3 or 6 months, 1 year, 2 year and 5 year |
| Change from baseline of implant survivorship | Assessment of bone fracture, implant fracture, neck reabsorption | Post-operative 3 or 6 months, 1 year, 2 year, and 5 year |
| Change in baseline of Complications | Assessment of Adverse events and serious adverse events | Day of surgery, post-operative 3 or 6 months, 1 year, 2 year, and 5 year. |
| Change in baseline fixation and wear | Radiographic analysis by measuring Radio Lucent Lines | Post-operative 3 or 6 months, 1 year, 2 year and 5 year |
| Change in baseline fixation | Radiographic analysis by measuring implant fixation in millimeters | Post-operative 3 or 6 months, 1 year, 2 year and 5 year |
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Inclusion Criteria:
Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Vail Orthopedics | Parker | Colorado | 80134 | United States | ||
| Saint Alphonsus Medical Group |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Boise |
| Idaho |
| 83706 |
| United States |
| Illinois Bone and Joint Institute | Libertyville | Illinois | 60048 | United States |
| McBride Orthopedic Hospital | Oklahoma City | Oklahoma | 73103 | United States |
| Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence | West Jordan | Utah | 84088 | United States |
| D012216 |
| Rheumatic Diseases |