Postmarketing Study to Determine Performance of the SIGMA HP® PARTIAL KNEE SYSTEM
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01529099 |
Recruitment Status
:
Completed
First Posted
: February 8, 2012
Last Update Posted
: May 30, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis Post-traumatic Arthritis Gout Pseudo-gout | Device: SIGMA HP PARTIAL KNEE | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Non-comparative, Single Centre Study to Determine the Performance & Survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM. |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | July 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Sigma HP Partial Knee
Partial knee replacement
|
Device: SIGMA HP PARTIAL KNEE
SIGMA HP PARTIAL KNEE
Other Names:
|
- Survivorship (revision) [ Time Frame: 2 years ]Kaplan Meier Survival analysis at 2 years (based on revision of the femoral or tibial components)
- Types and Frequency of Adverse Events [ Time Frame: Throughout the study ]
- Clinical outcome using the AKS score [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
- Patient-reported outcome using the KOOS assessment [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
- Patient-reported outcome using the HAAS assessment [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
- Patient-reported outcome using the Kujala score [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
- Patient-reported outcome using the Oxford Knee Score [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
- Patient-reported outcome using the EQ-5D assessment [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
- Radiographic assessment [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female subjects, aged at least 21 years.
- Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subject has non-inflammatory degenerative joint disease (NIDJD), including: osteoarthritis, posttraumatic arthritis, avascular necrosis and chondrocalcinosis.
- Subject has a functional stable knee.
- Subject, in the opinion of the Investigator, is suitable for either a single or bicompartmental knee replacement.
-
Subject meets the following selected radiographic parameters:
- X-ray evaluation confirms the presence of NIDJD
- Disease location: 1 to 2 compartments, maximum. Disease can be present in the patellofemoral compartment, the medial tibiofemoral compartment, lateral tibiofemoral compartments alone or in any two compartments.
- Disease severity: Kellgren and Lawrence44 Grade II or greater for all compartments replaced.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529099
Italy | |
Orthopedic Institute IRCCS Galeazzi | |
Milan, Italy | |
CDC, Citta di Palma | |
Parma, Italy | |
Switzerland | |
Schulthess Klinik | |
Zurich, Switzerland |
Responsible Party: | DePuy International |
ClinicalTrials.gov Identifier: | NCT01529099 History of Changes |
Other Study ID Numbers: |
CT10/01 |
First Posted: | February 8, 2012 Key Record Dates |
Last Update Posted: | May 30, 2016 |
Last Verified: | June 2015 |
Keywords provided by DePuy International:
History of Gout or pseudo-gout. Osteoarthritis Knee Knee replacement Knee implant Knee arthroplasty Unicompartmental Primary |
Partial Patellofemoral Medial Lateral Bicompartmental Cemented Post-traumatic arthritis of the tibio-femoral and/or patellofemoral articular surfaces |
Additional relevant MeSH terms:
Gout Arthritis Osteoarthritis Chondrocalcinosis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Crystal Arthropathies Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases |