Clinical Results
A clinical study was performed to evaluate the safety and effectiveness of the CONSERVE® PLUS Total Resurfacing Hip System. Clinical trial data was collected on 1366 hips implanted with the CONSERVE® PLUS Total Resurfacing Hip System. Complication (safety) information was collected from this group of 1366 study procedures and, of these, 540 of 680 unilateral, original shell, cases comprised the 24-month safety group. Effectiveness information was collected from the 292 procedures in the Pivotal Unilateral Efficacy Cohort (original shell) and, of these, 264 were rated for pain and function (Harris Hip Score) at 24+ months after surgery.
Safety Data:
Complication (safety) information was collected from the entire group of 1366 study procedures and, of these, 540 of 680 unilateral, original shell cases completed the 24-month safety data collection process. Some complications occurred at a higher rate in CONSERVE® PLUS patients versus other hip replacement systems. These complications were:
- Bone formation in surrounding tissue (heterotopic ossification)
- Bruising and swelling (hematoma)
- Infection
- Nerve problem
- Pain
- Wound problems
- Tenderness on the upper, outside portion of the thighbone (trochanteric bursitis)
However, the overall complication rate and types of complications were similar to the types reported for other hip replacement systems. The revision rate between CONSERVE® PLUS patients and other hip replacement systems was also similar. 36 of 540 (6.7%) CONSERVE® PLUS patients required revision surgery. Reasons for revision in these 36 patients were: fracture of the neck of the thigh bone (19), loosening of the implant (6), infection (4), impingement of the implant (2), migration of the implant (1), protrusion of the implant into the wall of the pelvis bone (1), pain (1), and other reasons (2). There were no deaths directly related to the use of the device inthe study.
Effectiveness Data:
Effectiveness information was collected from the 292 procedures in the Pivotal Unilateral Efficacy Cohort (original shell) and, of these, 264 were rated for pain and function (Harris Hip Score) at 24+ months after surgery. Harris Hip Total scores were summarized in categories used to summarize clinical outcome. This scoring system is used to tell doctors how well patients are functioning with their hip replacement including their ability to walk (with or without a walking aid), and the patient’s level of pain. Refer to Table 1.
For additional information on the CONSERVE® PLUS Total Resurfacing Hip System, please review the patient information brochure.
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