Postmarketing Study to Determine Performance of the SIGMA HP® PARTIAL KNEE SYSTEM
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: December 6, 2011
Last updated: April 22, 2014
Last verified: April 2014
This is a postmarketing study to assess the overall performance and survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.
Device: SIGMA HP PARTIAL KNEE
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Prospective, Non-comparative, Single Centre Study to Determine the Performance & Survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.
Primary Outcome Measures:
Other Outcome Measures:
- Types and Frequency of Adverse Events [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2015 (Final data collection date for primary outcome measure)
Experimental: Sigma HP Partial Knee
Device: SIGMA HP PARTIAL KNEE
SIGMA HP PARTIAL KNEE
- Sigma HP Partial Knee Femoral component
- Sigma HP Partial Knee Tibial component
- Sigma HP Partial Knee Tibial insert component
- Sigma Patellae
- Sigma HP Partial Knee Trochlear component
The purpose of this study is to collect more information about the Sigma HP® Partial Knee System made by DePuy International. The aim of this study is to measure how this particular type of knee replacement performs over a two year period.
|Ages Eligible for Study:
||21 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical investigation with an investigational product in the last 3 months.
- Subjects who are currently involved in any injury litigation claims.
- Multiple joint involvement that will compromise rehabilitation (for example: advanced hip, ankle or spine disease).
- Known to be a prisoner, mentally incompetent, an alcohol / drug abuser, involved in medical-legal case or worker's compensation
- Previous knee arthroplasty (any type) in any one of the three compartments of the knee.
- Requires more than a lateral soft tissue release or an anterior cruciate ligament reconstruction.
- Uncorrectable anatomical tibio-femoral angle.
- Bone deficiency requiring structural bone grafts to support the implants.
- Previous patellectomy.
- For Subjects indicated for a patellofemoral arthroplasty, Subject has uncorrected patella baja (Caton-Deschamps ratio less than or equal to 0.6).
- Tri-compartmental disease process (patella-femoral, medial tibio-femoral and lateral tibio-femoral).
- Active bacterial infection that may spread to other areas of the body (e.g., osteomyelitis, pyogenic infection of knee joint, urinary tract infection, etc.).
- Significant neurological or musculoskeletal deformity or a disease that may affect gait or weight bearing, (e.g., muscular dystrophy, multiple sclerosis, amputation).
- Known allergy to implant materials.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529099
|Zurich, Switzerland |
||Dr. Stefan Preiss, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 6, 2011
||April 22, 2014
Switzerland: Federal Office of Public Health
Switzerland: Laws and standards
Keywords provided by DePuy International:
Post-traumatic arthritis of the tibio-femoral and/or patellofemoral articular surfaces
History of Gout or pseudo-gout.
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 27, 2015