Total Knee Replacement RevisionNCT02412813
LEGION™ Revision Metal Hypersensitivity Study
A study testing LEGION OXINIUM and LEGION Cobalt Chrome in people with Total Knee Replacement Revision, run by Smith & Nephew, Inc. at 3 sites in 2 countries.
Trial summary
This is a prospective, randomized, multi-center, metal hypersensitivity study comparing OXINIUM and cobalt chrome femoral components in subjects with failed total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Replacement Revision
- What is being tested?
- LEGION OXINIUM and LEGION Cobalt Chrome
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2016to Apr 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is skeletally mature
- Subject is willing to sign and date an IRB/EC approved consent form
- Subject is a candidate for a revision knee replacement
- Subject has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, infection, or other conditions that would pose excessive operative risk
- Subject agrees to adhere to the 10-year study visit schedule
Who cannot join
- Subject with a known metal hypersensitivity
- Subject requires a known bilateral revision TKA
- Subject has severe pronation of the ipsilateral foot or any other relevant clinical condition contributing to abnormal ambulation
- Subject has active infection or sepsis (treated or untreated)
- Subject with an immunosuppressive disorder
- Subject has presence of malignant tumor, metastatic, or neoplastic disease
Show all 13Show fewer
- Subject has conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
- Subject has had intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment
- Subject has inadequate bone stock to support the device and would require significant augmentation to correct the joint Female subject is of child-bearing age and unwilling to use an approved method of contraception
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to comply with the study
- Subject is severely overweight (BMI>40)
- Subject is currently enrolled in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days
- Subject is facing current or impending incarceration
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Rothman Institute
Egg Harbor, New Jersey, 08234
Columbia University Medical Center
New York, New York, 10038
About this study
Official title: A Prospective, Randomized, Multi-Center, Metal Hypersensitivity Study Comparing OXINIUM and Cobalt Chrome Femoral Components in Failed Total Knee Arthroplasty
This is a prospective, randomized, multi-center, metal hypersensitivity study comparing OXINIUM and cobalt chrome femoral components in subjects with failed total knee arthroplasty (TKA).
Read the detailed description
A total of 230 subjects will be randomized (1:1) to receive either an OXINIUM or cobalt chrome femoral components as part of their LEGION revision procedure. The objective of this study is to assess a lower serum metal ion concentration level in at least one of the three major mLTTs (Co, Cr or Ni) over 5 years in subjects receiving OXINIUM versus Cobalt Chrome femoral components as part of the LEGION Revision Total Knee System.
- Conditions
- Total Knee Replacement Revision
- Being tested
- LEGION OXINIUM, LEGION Cobalt Chrome
- Keywords
- hypersensitivity, metal sensitivity, arthroplasty, implant-related hypersensitivity, metal-on-metal implants, knee revision
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEGION OXINIUMDevice
Investigational Group
LEGION Cobalt ChromeDevice
Control Group
| Study group | Role | What they receive |
|---|---|---|
| LEGION OXINIUM femoral component | Active comparator | Not described Receives: Device: LEGION OXINIUM |
| LEGION Cobalt Chrome femoral components | Active comparator | Not described Receives: Device: LEGION Cobalt Chrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major modified Lymphocyte Transformation Tests (Cobalt, Chromium and Nickel) measurements
Metal hypersensitivity will be concluded if at least one of these three measurements is statistically significant
Measured: 3,650 Days
Secondary outcomes (7)
Minor modified Lymphocyte Transformation Tests (Aluminum, Iron, Molybdenum, Vanadium and Zirconium)
changes in mean mLTTs serum concentration values from baseline to each subsequent assessment
Measured: 3,650 Days
Changes in mean serum bio-markers from baseline to each subsequent assessment
Measured: 3,650 Days
Skin lesion evaluation to measure hypersensitivity
Measured: 3,650 Days
Revision of LEGION Revision Knee System for any reason at each post-surgical assessment
Measured: 3,650 Days
Improves in mean 2011 Knee Society Score (2011 KSS) from baseline to each subsequent assessment
Measured: 3,650 Days
Anteroposterior, lateral and skyline knee views are assessed by radiographs
Measured: 3,650 Days
All adverse event reporting from surgery to 10 year post-surgery
Measured: 3,650 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startJan 2016
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Why it stopped: Overhaul of Study Design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Replacement RevisionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Turgeon, MD, Principal investigator, Orthopaedic Innovation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412813
- Sponsor's protocol ID
- 13-4050-05
- Status last verified
- Mar 2016
- First submitted
- 5 Mar 2015
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-Center, Metal Hypersensitivity Study Comparing OXINIUM and Cobalt Chrome Femoral Components in Failed Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02412813
- Acronym / sponsor ID
- 13-4050-05
- Conditions
- Total Knee Replacement Revision
- Keywords
- hypersensitivity, metal sensitivity, arthroplasty, implant-related hypersensitivity, metal-on-metal implants, knee revision
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Overhaul of Study Design
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 9 Apr 2015 (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 prospective, randomized, multi-center, metal hypersensitivity study comparing OXINIUM and cobalt chrome femoral components in subjects with failed total knee arthroplasty (TKA).
Detailed description
A total of 230 subjects will be randomized (1:1) to receive either an OXINIUM or cobalt chrome femoral components as part of their LEGION revision procedure. The objective of this study is to assess a lower serum metal ion concentration level in at least one of the three major mLTTs (Co, Cr or Ni) over 5 years in subjects receiving OXINIUM versus Cobalt Chrome femoral components as part of the LEGION Revision Total Knee System.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEGION OXINIUM femoral component | Active comparator | Device: LEGION OXINIUM |
| LEGION Cobalt Chrome femoral components | Active comparator | Device: LEGION Cobalt Chrome |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is skeletally mature
- Subject is willing to sign and date an IRB/EC approved consent form
- Subject is a candidate for a revision knee replacement
- Subject has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, infection, or other conditions that would pose excessive operative risk
- Subject agrees to adhere to the 10-year study visit schedule
Key exclusion criteria (13 listed)
- Subject with a known metal hypersensitivity
- Subject requires a known bilateral revision TKA
- Subject has severe pronation of the ipsilateral foot or any other relevant clinical condition contributing to abnormal ambulation
- Subject has active infection or sepsis (treated or untreated)
- Subject with an immunosuppressive disorder
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 |
|---|---|---|
| LEGION OXINIUMInvestigational Group | Device | LEGION OXINIUM femoral component |
| LEGION Cobalt ChromeControl Group | Device | LEGION Cobalt Chrome femoral components |
Primary outcome
Major modified Lymphocyte Transformation Tests (Cobalt, Chromium and Nickel) measurements
Time frame: 3,650 Days
Metal hypersensitivity will be concluded if at least one of these three measurements is statistically significant
7 secondary outcomes
Minor modified Lymphocyte Transformation Tests (Aluminum, Iron, Molybdenum, Vanadium and Zirconium)
Time frame: 3,650 Days
Changes in mean serum bio-markers from baseline to each subsequent assessment
Time frame: 3,650 Days
Skin lesion evaluation to measure hypersensitivity
Time frame: 3,650 Days
Revision of LEGION Revision Knee System for any reason at each post-surgical assessment
Time frame: 3,650 Days
Improves in mean 2011 Knee Society Score (2011 KSS) from baseline to each subsequent assessment
Time frame: 3,650 Days
Anteroposterior, lateral and skyline knee views are assessed by radiographs
Time frame: 3,650 Days
All adverse event reporting from surgery to 10 year post-surgery
Time frame: 3,650 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 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.
Thomas Turgeon, MD principal investigator
Orthopaedic Innovation Centre
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LEGION OXINIUM and LEGION Cobalt Chrome in people with Total Knee Replacement Revision, run by Smith & Nephew, Inc. 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 5 inclusion and 13 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: withdrawn, as of the sponsor's last update on 9 Mar 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 United States, Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Major modified Lymphocyte Transformation Tests (Cobalt, Chromium and Nickel) measurements (time frame: 3,650 Days). 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 9 Mar 2016.