Osteoarthritis, KneeNCT03224689
Evaluation of The Safety And Performance of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component
A study testing PEEK-Optima Femoral Component in people with Osteoarthritis, Knee and Rheumatoid Arthritis of Knee, run by Maxx Orthopedics Inc at 1 site in Belgium.
Trial summary
Prospective, multi-centre, non-comparative, post-market surveillance clinical study Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Rheumatoid Arthritis of Knee, Traumatic Arthritis of Knee (Diagnosis)
- What is being tested?
- PEEK-Optima Femoral Component
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2021to 1 Mar 2024
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 50 years of age or older and less than 75 years of age (>50 and <75 years).
- Subjects who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a total knee arthroplasty by the Investigator.
- Subjects with a primary diagnosis of end-stage symptomatic primary knee osteoarthritis
- Subjects who, in the opinion of the 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.
- Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
Who cannot join
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
- 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 study with an investigational product in the last 6 months.
- Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e muscular dystrophy, polio, neuropathic joints).
- Subjects with a BMI of 32 or above.
- Subjects with a current or active history of malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed, rheumatoid arthritis, sickle cell anemia, and systemic lupus erythematosus.
Show all 14Show fewer
- Subjects with a primary or secondary diagnosis of inflammatory or traumatic arthritis.
- Subjects defined by the Investigator as ASA Grade III or IV.
- Subjects who have a neuromuscular or neurosensory deficit.
- Female subjects who are pregnant or lactating.
- Subjects with an anatomical limb alignment of above 20 degrees varus or valgus.
- Subjects with a fixed flexion deformity of over 20 degrees.
- Subjects with recurvatum (definition: hyperextension ≥ 5 degrees).
- Subjects who have previously undergone total or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, ORIF or with previous fracture in the ipsilateral knee joint.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
More Institue, Department of Orthopedic Surgery
Antwerp
Peter Verdonk, MD, PhD, pverdonk@yahoo.com
About this study
Official title: A Multi-Centre Clinical Investigation To Evaluate The Safety And Performance Of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component
Prospective, multi-centre, non-comparative, post-market surveillance clinical study
Read the detailed description
PRIMARY ENDPOINT:
- The primary endpoint is to evaluate the procedural success ie successful implantation of the device in the opinion of the surgeon
SECONDARY ENDPOINTS:
The secondary endpoints are to evaluate:
- KSS Knee scores and KSS Function scores at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment
- Subject reported outcomes (SF-36, Oxford Knee Score and WOMAC) at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment
- Stability of the device through radiographic analysis to assess alignment and component position at immediate post-treatment, 6 weeks, 6, 12 and 24 months post-treatment
- Safety in terms of adverse events and device deficiencies throughout the clinical investigation including any additional knee treatments and/or surgery
- Survivorship analysis of the device at 12 and 24 months and annually thereafter
- Conditions
- Osteoarthritis, Knee, Rheumatoid Arthritis of Knee, Traumatic Arthritis of Knee (Diagnosis), Polyarthritis, Fractures, Bone
- Being tested
- PEEK-Optima Femoral Component
- Medical subject headings
- Osteoarthritis, Knee, Disease, Arthritis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEK-Optima Femoral ComponentDevice
TKA Surgery
| Study group | Role | What they receive |
|---|---|---|
| PEEK Femoral | Experimental | Subjects with a primary diagnosis of end-stage symptomatic primary knee osteoarthritis who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a total knee arthroplasty by the Investigator will be invited to take part in this clinical investigation. Receives: Device: PEEK-Optima Femoral Component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score (KSS)
Pre-and post-operative function and patient and mechanical assessment. The KSS contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). The greater score correlates to better outcome.
Measured: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
Secondary outcomes (4)
Visual Analog Scale (VAS)
Patient self administered overall satisfaction (scale from 1 worse -10 best)
Measured: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
SF-36
Assessment domains to explain variations in patient outcomes. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Assessment of OA of the knee or hip. Possible score range of 0- 20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function
Measured: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
Radiographic assessment
Subjective review and assessment of serial radiographs. Items include presence or absence of radiographic evidence of component loosening, malposition, migration and periprosthetic osteolysis, bone loss or interface composite (bone-cement-component) breakdown.
Measured: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxx Orthopedics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Verdonk, MD, PhD, Principal investigator, More Institute, Antwerp, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224689
- Sponsor's protocol ID
- MI-001
- Status last verified
- Jul 2021
- First submitted
- 18 Jul 2017
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre Clinical Investigation To Evaluate The Safety And Performance Of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component
- ClinicalTrials.gov ID
- NCT03224689
- Acronym / sponsor ID
- MI-001
- Conditions
- Osteoarthritis, Knee, Rheumatoid Arthritis of Knee, Traumatic Arthritis of Knee (Diagnosis), Polyarthritis, Fractures, Bone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Maxx Orthopedics IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 21 Jul 2017 (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.
Prospective, multi-centre, non-comparative, post-market surveillance clinical study
Detailed description
PRIMARY ENDPOINT:
- The primary endpoint is to evaluate the procedural success ie successful implantation of the device in the opinion of the surgeon
SECONDARY ENDPOINTS:
The secondary endpoints are to evaluate:
- KSS Knee scores and KSS Function scores at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment
- Subject reported outcomes (SF-36, Oxford Knee Score and WOMAC) at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment
- Stability of the device through radiographic analysis to assess alignment and component position at immediate post-treatment, 6 weeks, 6, 12 and 24 months post-treatment
- Safety in terms of adverse events and device deficiencies throughout the clinical investigation including any additional knee treatments and/or surgery
- Survivorship analysis of the device at 12 and 24 months and annually thereafter
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEEK Femoral | Experimental | Device: PEEK-Optima Femoral ComponentSubjects with a primary diagnosis of end-stage symptomatic primary knee osteoarthritis who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a total knee arthroplasty by the Investigator will be invited to take part in this clinical investigation. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects aged 50 years of age or older and less than 75 years of age (>50 and <75 years).
- Subjects who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a total knee arthroplasty by the Investigator.
- Subjects with a primary diagnosis of end-stage symptomatic primary knee osteoarthritis
- Subjects who, in the opinion of the 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.
- Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
Key exclusion criteria (14 listed)
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
- 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 study with an investigational product in the last 6 months.
- Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e muscular dystrophy, polio, neuropathic joints).
- Subjects with a BMI of 32 or above.
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 |
|---|---|---|
| PEEK-Optima Femoral ComponentTKA Surgery | Device | PEEK Femoral |
Primary outcome
Knee Society Score (KSS)
Time frame: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
Pre-and post-operative function and patient and mechanical assessment. The KSS contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). The greater score correlates to better outcome.
4 secondary outcomes
Visual Analog Scale (VAS)
Time frame: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
SF-36
Time frame: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
Radiographic assessment
Time frame: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Peter Verdonk, MD, PhD principal investigator
More Institute, Antwerp, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEK-Optima Femoral Component in people with Osteoarthritis, Knee and Rheumatoid Arthritis of Knee, run by Maxx Orthopedics Inc at 1 site in Belgium.
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 14 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: status not confirmed, as of the sponsor's last update on 15 Jul 2021. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Eberle (+1 (919) 280-6900, robert.eberle@maxxortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society Score (KSS) (time frame: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 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 15 Jul 2021.