Knee OsteoarthritisKA vs MANCT05461638
Kinematic Alignment vs Mechanical Alignment for Total Knee Arthroplasty
A study testing Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with MyKnee Custom guides and Mechanical Alignment and Restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides in people with Knee Osteoarthritis and Knee Pain Chronic, run by Medacta USA.
Trial summary
This is a prospective, randomized, single-blinded, multi-center trial comparing Kinematic Alignment vs Mechanical Alignment in TKA patients using patient reported outcomes, clinical and functional performance tests and radiographic analyses. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Knee Pain Chronic
- What is being tested?
- Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with MyKnee Custom guides and Mechanical Alignment and Restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2020to 5 Apr 2022
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).
- Ability to understand and provide written authorization for use and disclosure of personal health information.
- Subject who are able and willing to comply with the study protocol and follow-up visits.
- Must be 21 years or older to participate, and less than 80 years old.
- Subjects must have osteoarthritis knee disease in the affected knee compliant with the FDA-approved indications for use of GMK Sphere knee system and MyKnee cutting blocks.
- Patients who are candidates for Total Knee Arthroplasty and are determined to undergo a TKA using the Medacta GMK Sphere implant and MyKnee cutting blocks will be offered enrollment.
- Subjects must be able to return for the follow-up appointments, and have the mental capacity to cooperate and complete PRO questionnaires, physical exam and radiographs.
Who cannot join
- • Cases of extreme bone loss requiring an augmented femoral or tibial implant and chronic ligamentous laxity requiring a constrained implant
- The patient has a fixed flexion deformity of ≥15°
- The patient has less than 90° of flexion
- Patient is morbidly obese (BMI ≥40)
- Patient with inflammatory arthritis
- History of prior deep knee infection
Show all 21Show fewer
- History of alcoholism or drug abuse
- Currently on chemotherapy or radiation therapy for neoplastic disease
- Patient currently on immunosuppressive medications including steroids except when, (a) steroid use is less than 10mg daily, (b) other immunosuppressive medications are held for appropriate time, for example Adalimumab is held 2 weeks prior and 2 weeks after surgery
- History of known sensitivity or allergy to materials used in orthopedic implants, specifically Titanium and Cobalt-Chrome alloys
- Habitual use of narcotic pain medications prior to surgery (more than 2 doses daily and chronic use of a minimum 3 months)
- History of metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis (e.g., Osteomalacia, Ricketts)
- History of chronic pain issues for reasons other than knee joint pain. If the type of pain affects activities of daily living, do not enroll. If the pain is intermittent and does not affect activities of daily living, it is OK to enroll. Fibromyalgia is exclusionary.
- Women who are pregnant
- Patient with unstable psychiatric illness or psychosis is excluded. (Patients with stable anxiety or depression can be enrolled if PI determines that the condition does not adversely affect study outcomes \& requirements)
- Any patient, in the opinion of the investigator, is unable to fully comply with the surgical, rehabilitation, or follow-up aspects of this procedure.
- Prior surgery on the target knee other than arthroscopy and/or arthroscopically-assisted ligament reconstruction
- Prior high tibial osteotomy (HTO) or femoral osteotomy
- Malunion of fracture of a tibia or femur
- Patient with a neuromuscular or neurosensory deficiency
- Patient with history of knee fusion in the affected joint
About this study
Official title: A Prospective, Randomized, Single-Blinded, Multi-Center, Clinical Trial Comparing Kinematic Alignment vs. Mechanical Alignment Using Medially-Stabilized Knee (GMK Sphere) And Patient-Specific Cutting Guides (MyKnee) For Total Knee Arthroplasty
This is a prospective, randomized, single-blinded, multi-center trial comparing Kinematic Alignment vs Mechanical Alignment in TKA patients using patient reported outcomes, clinical and functional performance tests and radiographic analyses.
Read the detailed description
This is a prospective, randomized, single-blinded, multi-center trial comparing Kinematic Alignment vs Mechanical Alignment in TKA patients with Medacta GMK Sphere knee system using patient specific instrumentation Medacta MyKnee. Patients will be assessed a pre-operative, operative and interim post-operative visits, week 6, month 6 and 1,2,5 \& 10 years. There will be a phone survey follow up at year 3,4,6,7,8,\& 9.
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic
- Being tested
- Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with MyKnee Custom guides, Mechanical Alignment and Restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with MyKnee Custom guidesProcedure or surgery
MA places the implant in an average position for all patients based on pre-determined definition of acceptable knee alignment and has become the most common surgical approach for TKA and Unrestricted KA places the implant in a custom position for each patient, completely matching individual anatomy and restoring natural alignment to that of the prearthritic knee.
Mechanical Alignment and Restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guidesProcedure or surgery
MA places the implant in an average position for all patients based on pre-determined definition of acceptable knee alignment and has become the most common surgical approach for TKA and Restricted KA places the implant in a custom position for each patient, closely matching with anatomy and natural alignment of the individual's knee.
| Study group | Role | What they receive |
|---|---|---|
| Unrestricted Kinematic Alignment | Active comparator | Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides Receives: Procedure: Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with MyKnee Custom guides |
| Restricted Kinematic Alignment | Active comparator | Mechanical Alignment and restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides Receives: Procedure: Mechanical Alignment and Restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Forgotten Joint Score
Assessment of the improvement of joint specific outcomes following knee replacement surgery using the Knee Forgotten Joint Score
Measured: Post operative 4-132 months
Secondary outcomes (6)
Change from baseline in Knee Osteoarthritis Outcome Score (KOOS)
Assessment of improvement of activity levels following knee replacement surgery using the KOOS
Measured: Baseline to Post operative 4-132 months
Change from baseline in Knee Society Score
Patient specific patient outcomes scoring
Measured: Baseline to Post operative 4-132 months
Change from baseline in Knee Society Score
Clinical Exam Range of Motion, Stability and Alignment
Measured: Baseline to Post operative 4-132 months
Change from baseline in PROMIS
Pain Intensity, Pain Interference, and physical function scoring
Measured: Baseline to Post operative 4-132 months
Change in Baseline in Knee Alignment
Determined by radiographic analysis measured by angle of degrees
Measured: Baseline to Post operative 4-132 months
Change from Baseline of Implant Position Fixation
Determined by radiographic analysis by measure radio lucent lines in millimeters
Measured: Baseline to Post operative 4-132 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start5 Jan 2020 (estimated)
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Why it stopped: No viable sites
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rena Mandino, Study director, Associate Director, Clinical Research Medacta USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461638
- Sponsor's protocol ID
- MUSA-K-KA-001
- Acronym
- KA vs MA
- Status last verified
- Jul 2022
- First submitted
- 30 Mar 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single-Blinded, Multi-Center, Clinical Trial Comparing Kinematic Alignment vs. Mechanical Alignment Using Medially-Stabilized Knee (GMK Sphere) And Patient-Specific Cutting Guides (MyKnee) For Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05461638
- Acronym / sponsor ID
- KA vs MA / MUSA-K-KA-001
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No viable sites
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medacta USAIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2020 (estimated)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 18 Jul 2022 (actual)
- 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, single-blinded, multi-center trial comparing Kinematic Alignment vs Mechanical Alignment in TKA patients using patient reported outcomes, clinical and functional performance tests and radiographic analyses.
Detailed description
This is a prospective, randomized, single-blinded, multi-center trial comparing Kinematic Alignment vs Mechanical Alignment in TKA patients with Medacta GMK Sphere knee system using patient specific instrumentation Medacta MyKnee. Patients will be assessed a pre-operative, operative and interim post-operative visits, week 6, month 6 and 1,2,5 \& 10 years. There will be a phone survey follow up at year 3,4,6,7,8,\& 9.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unrestricted Kinematic Alignment | Active comparator | Procedure: Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with MyKnee Custom guidesMechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides |
| Restricted Kinematic Alignment | Active comparator | Procedure: Mechanical Alignment and Restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guidesMechanical Alignment and restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).
Key exclusion criteria (21 listed)
- • Cases of extreme bone loss requiring an augmented femoral or tibial implant and chronic ligamentous laxity requiring a constrained implant
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 |
|---|---|---|
| Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with MyKnee Custom guidesMA places the implant in an average position for all patients based on pre-determined definition of acceptable knee alignment and has become the most common surgical approach for TKA and Unrestricted KA places the implant in a custom position for each patient, completely matching individual anatomy and restoring natural alignment to that of the prearthritic knee. | Procedure or surgery | Unrestricted Kinematic Alignment |
| Mechanical Alignment and Restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guidesMA places the implant in an average position for all patients based on pre-determined definition of acceptable knee alignment and has become the most common surgical approach for TKA and Restricted KA places the implant in a custom position for each patient, closely matching with anatomy and natural alignment of the individual's knee. | Procedure or surgery | Restricted Kinematic Alignment |
Primary outcome
Change from baseline in Forgotten Joint Score
Time frame: Post operative 4-132 months
Assessment of the improvement of joint specific outcomes following knee replacement surgery using the Knee Forgotten Joint Score
6 secondary outcomes
Change from baseline in Knee Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline to Post operative 4-132 months
Change from baseline in Knee Society Score
Time frame: Baseline to Post operative 4-132 months
Change from baseline in Knee Society Score
Time frame: Baseline to Post operative 4-132 months
Change from baseline in PROMIS
Time frame: Baseline to Post operative 4-132 months
Change in Baseline in Knee Alignment
Time frame: Baseline to Post operative 4-132 months
Change from Baseline of Implant Position Fixation
Time frame: Baseline to Post operative 4-132 months
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 18 Jul 2022.
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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.
Rena Mandino study director
Associate Director, Clinical Research Medacta USA
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with MyKnee Custom guides and Mechanical Alignment and Restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides in people with Knee Osteoarthritis and Knee Pain Chronic, run by Medacta USA.
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 21 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 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline in Forgotten Joint Score (time frame: Post operative 4-132 months). 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 18 Jul 2022.