OsteoarthritisNCT01656694
A Single-Center, Epidemiological Study of the Survivorship of the DePuy Sigma HP Unicompartmental Knee Prosthesis
An observational study of Osteoarthritis and Unicompartmental Knee Arthroscopy, run by Mississippi Sports Medicine and Orthopaedic Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Unicompartmental Knee Arthroscopy
- What is being tested?
- DePuy Sigma HP Partial Knee
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Since the first Sigma® HP Partial Knee System was introduced at MSMOC, over 1,000 have been implanted in patients by the investigators of this study. The population used for this study was the first patients of our clinic to receive this particular prosthesis. The first replacement was implanted on August 21, 2008. By October 31, 2009, 300 patients had received the Sigma® HP replacement. These 300 patients will be the subject population whose data will be analyzed for the study upon their consent.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mississippi Sports Medicine and Orthopaedic Center
Jackson, Mississippi, 39202
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Osteoarthritis, Unicompartmental Knee Arthroscopy
- Being tested
- DePuy Sigma HP Partial Knee
- Keywords
- Osteoarthritis, Knee, Replacement, Unicompartmental, DePuy, Sigma HP
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DePuy Sigma HP Partial KneeDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Five-Year Survivorship
The primary endpoint of the study is to determine the five-year survivorship of the Sigma® HP Partial Knee System with failure defined as revision for any reason.
Measured: Five Years Post-Op
Secondary outcomes (4)
Five-Year Survivorship Alternately Defining Failure and Two-Year Survivorship
One secondary endpoint of the study is to determine the five-year survivorship of the prosthesis with alternately defining failure as: failure of implant, failure secondary to infection, failure secondary to progression of arthritis, failure secondary to periprosthetic fracture.
We also want to determine the two-year survivorship with failure defined as revision for any reason.
Measured: Two Years and Five Years Post-Op
Functional Outcomes
Another secondary endpoint of the study is to analyze the functional outcomes for five-year data based on the Knee Society score and the KOOS (Knee Injury and Osteoarthritis Outcome Score) score, reported as changes from the pre-operative score. By using both rating systems, an appropriate evaluation of the functional outcome of the surgery should be obtained.
Measured: Five Years Post-Op
Radiographic Outcomes
Another secondary endpoint of the study is to determine the radiographic outcomes based upon the radiographic assessment using the Knee Society scoring system, reported as changes from the pre-operative assessment. Additionally, we want to radiographically assess lucencies at the bone cement and implant cement interface to measure wear and loosening of the prosthesis.
Measured: Pre-Operatively, Two and Five-Year Post-Op
Adverse Advents
We also want to examine the type and frequency of adverse events as a secondary endpoint of the study. Safety will be evaluated with summary of adverse events.
Measured: Post-Operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startAug 2012
- Primary completion31 Dec 2015
- Study completionDec 2016
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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mississippi Sports Medicine and Orthopaedic Center
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Jeff D Almand, MD, Principal investigator, Mississippi Sports Medicine and Orthopaedic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656694
- Sponsor's protocol ID
- 11018
- Status last verified
- Mar 2018
- First submitted
- 1 Aug 2012
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two and Five-Year Survivorship of Unicompartmental Knee Arthroplasty Using DePuy Sigma HP Replacement
- ClinicalTrials.gov ID
- NCT01656694
- Acronym / sponsor ID
- 11018
- Conditions
- Osteoarthritis, Unicompartmental Knee Arthroscopy
- Keywords
- Osteoarthritis, Knee, Replacement, Unicompartmental, DePuy, Sigma HP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Mississippi Sports Medicine and Orthopaedic CenterUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics
- Study start
- Aug 2012
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Aug 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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Since the first Sigma® HP Partial Knee System was introduced at MSMOC, over 1,000 have been implanted in patients by the investigators of this study. The population used for this study was the first patients of our clinic to receive this particular prosthesis. The first replacement was implanted on August 21, 2008. By October 31, 2009, 300 patients had received the Sigma® HP replacement. These 300 patients will be the subject population whose data will be analyzed for the study upon their consent.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| DePuy Sigma HP Partial Knee | Device | – |
Primary outcome
Five-Year Survivorship
Time frame: Five Years Post-Op
The primary endpoint of the study is to determine the five-year survivorship of the Sigma® HP Partial Knee System with failure defined as revision for any reason.
4 secondary outcomes
Five-Year Survivorship Alternately Defining Failure and Two-Year Survivorship
Time frame: Two Years and Five Years Post-Op
Functional Outcomes
Time frame: Five Years Post-Op
Radiographic Outcomes
Time frame: Pre-Operatively, Two and Five-Year Post-Op
Adverse Advents
Time frame: Post-Operatively
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 22 Mar 2018.
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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.
Jeff D Almand, MD principal investigator
Mississippi Sports Medicine and Orthopaedic Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Unicompartmental Knee Arthroscopy, run by Mississippi Sports Medicine and Orthopaedic Center at 1 site in United States.
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 7 inclusion and 4 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 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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?
Five-Year Survivorship (time frame: Five Years Post-Op). 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 22 Mar 2018.