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.
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 April 22, 2014
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn