A Single-Center, Epidemiological Study of the Survivorship of the DePuy Sigma HP Unicompartmental Knee Prosthesis
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | August 2012 |
| End Date: | December 2016 |
Two and Five-Year Survivorship of Unicompartmental Knee Arthroplasty Using DePuy Sigma HP Replacement
This study will be conducted to assess the survivorship of a particular prosthesis used in
unicompartmental knee arthroplasties. Patients undergoing this procedure have been diagnosed
with isolated medial or lateral compartmental arthritis and have failed conservative
treatment. The patients received a unicompartmental knee replacement using the Sigma® HP
Partial Knee System.
unicompartmental knee arthroplasties. Patients undergoing this procedure have been diagnosed
with isolated medial or lateral compartmental arthritis and have failed conservative
treatment. The patients received a unicompartmental knee replacement using the Sigma® HP
Partial Knee System.
This study is an epidemiological Level IV-Case Series clinical study that will study the
survivorship of the Sigma® HP Partial Knee System in a consecutive series of patients. All
patients who received the Sigma® HP Partial Knee System between August 21, 2008 and October
31, 2009 will be available to include in the study. Data will be collected preoperatively,
intra-operatively, and post-operatively at intervals of 6 weeks, 6 months, 1 year, 2 years,
and 5 years. Data will be analyzed for survivorship status at the 2- and 5-year follow-up
visits. Other data, including functional outcomes, radiographic outcomes, and wear will be
analyzed at the 5-year follow-up visit. Subjects will participate in the study for five years
after their surgery.
survivorship of the Sigma® HP Partial Knee System in a consecutive series of patients. All
patients who received the Sigma® HP Partial Knee System between August 21, 2008 and October
31, 2009 will be available to include in the study. Data will be collected preoperatively,
intra-operatively, and post-operatively at intervals of 6 weeks, 6 months, 1 year, 2 years,
and 5 years. Data will be analyzed for survivorship status at the 2- and 5-year follow-up
visits. Other data, including functional outcomes, radiographic outcomes, and wear will be
analyzed at the 5-year follow-up visit. Subjects will participate in the study for five years
after their surgery.
Inclusion Criteria:
- Adult patient over the age of 18
- Diagnosis of isolated medial or lateral compartmental osteoarthritis of the knee joint
- Must have failed conservative treatment and received a unicompartmental knee
arthroplasty between August 21, 2008 and October 31, 2009.
- Must have received the Sigma® HP Partial Knee System.
- Must have received the surgery from Dr. Almand, Dr. Johnson, or Dr. Pickering at
Mississippi Sports Medicine and Orthopaedic Center.
- Must be willing to provide written consent to participate in the study.
- Subjects who do not have the legal capacity to consent may be enrolled in the study by
a Legally Authorized Representative (LAR). The LAR must provide verification that they
have the legal authority to represent the subject.
Exclusion Criteria:
- Did not receive a unicompartmental knee arthroplasty between August 21, 2008 and
October 31, 2009.
- Did not receive a unicompartmental knee arthroplasty using the Sigma® HP Partial Knee.
- Did not receive their unicompartmental knee replacement from Dr. Almand, Dr. Johnson,
or Dr. Pickering at Mississippi Sports Medicine and Orthopaedic Center.
- Subjects lost to follow-up for any reason including, but not limited to: refusal to
consent, death, or geographic isolation will also be excluded from the study.
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