OsteoarthritisPhase 4NCT01529099
Postmarketing Study to Determine Performance of the SIGMA HP® PARTIAL KNEE SYSTEM
A Phase 4 study testing SIGMA HP PARTIAL KNEE in people with Osteoarthritis and Post-traumatic Arthritis, run by DePuy International at 3 sites in 2 countries.
Trial summary
This is a postmarketing study to assess the overall performance and survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Post-traumatic Arthritis, Gout
- What is being tested?
- SIGMA HP PARTIAL KNEE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2009to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: A Prospective, Non-comparative, Single Centre Study to Determine the Performance & Survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.
This is a postmarketing study to assess the overall performance and survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.
Read the detailed description
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.
- Conditions
- Osteoarthritis, Post-traumatic Arthritis, Gout, Pseudo-gout
- Being tested
- SIGMA HP PARTIAL KNEE
- Keywords
- 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, History of Gout or pseudo-gout.
- Medical subject headings
- Osteoarthritis, Gout, Chondrocalcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIGMA HP PARTIAL KNEEDevice
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Sigma HP Partial Knee | Experimental | Partial knee replacement Receives: Device: SIGMA HP PARTIAL KNEE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship (revision)
Kaplan Meier Survival analysis at 2 years (based on revision of the femoral or tibial components)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startJan 2009
- Primary completionJan 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529099
- Sponsor's protocol ID
- CT10/01
- Status last verified
- Jun 2015
- First submitted
- 6 Dec 2011
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-comparative, Single Centre Study to Determine the Performance & Survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.
- ClinicalTrials.gov ID
- NCT01529099
- Acronym / sponsor ID
- CT10/01
- Conditions
- Osteoarthritis, Post-traumatic Arthritis, Gout, Pseudo-gout
- Keywords
- Osteoarthritis, Knee, Knee replacement, Knee implant, Knee arthroplasty, Unicompartmental, Primary, Partial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a postmarketing study to assess the overall performance and survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sigma HP Partial Knee | Experimental | Device: SIGMA HP PARTIAL KNEEPartial knee replacement |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIGMA HP PARTIAL KNEEAlso: Sigma HP Partial Knee Femoral component, Sigma HP Partial Knee Tibial component, Sigma HP Partial Knee Tibial insert component, Sigma PatellaeSIGMA HP PARTIAL KNEE | Device | Sigma HP Partial Knee |
Primary outcome
Survivorship (revision)
Time frame: 2 years
Kaplan Meier Survival analysis at 2 years (based on revision of the femoral or tibial components)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SIGMA HP PARTIAL KNEE in people with Osteoarthritis and Post-traumatic Arthritis, run by DePuy International at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship (revision) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.