Knee OsteoarthritisNCT03289754
A Prospective Study to Evaluate the iTotal Knee and iPoly XE Tibial Inserts
A study testing iPoly XE tibial insert with ConforMIS iTotal KRS in people with Knee Osteoarthritis, run by Restor3D at 1 site in Germany.
Trial summary
This study is designed to evaluate the clinical outcomes of subjects who have recently undergone surgery with the iTotal® Cruciate Retaining (CR) Total Knee Replacement System (KRS) who have also had iPoly XE Tibial Inserts implanted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- iPoly XE tibial insert with ConforMIS iTotal KRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- 24 Jan 2018to 9 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Clinical condition included in the approved Indications For Use for the iTotal® CR
- Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment.
- Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
- > 18 years of age
Who cannot join
- Simultaneous bilateral procedure required
- BMI > 40
- Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
- Poorly controlled diabetes
- Neuromuscular conditions which prevent patient from participating in study activities
- Active local or systemic infection
Show all 21Show fewer
- Immunocompromised
- Fibromyalgia or other general body pain related condition
- Rheumatoid arthritis or other forms of inflammatory joint disease
- Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated on, to an extent that the procedure is unjustified
- Diagnosed with or receiving treatment for Osteoporosis
- Other physical disability affecting the hips, spine, or contralateral knee
- Severe instability due to advanced loss of osteochondral structure
- Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)
- Compromised PCL or collateral ligament
- Severe fixed valgus or varus deformity of >15º
- Extensor lag > 15º
- Fixed flexion contracture ≥ 15º
- Unwilling or unable to comply with study requirements
- Participation in another clinical study which would confound results
- Allergy to any of the implant materials
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center of Johannes Gutenberg-University Mainz
Mainz
About this study
Official title: A Prospective Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System and iPoly XE Tibial Inserts
This study is designed to evaluate the clinical outcomes of subjects who have recently undergone surgery with the iTotal® Cruciate Retaining (CR) Total Knee Replacement System (KRS) who have also had iPoly XE Tibial Inserts implanted.
Read the detailed description
The study is prospective and single-center. Subjects will be implanted with an iTotal® CR Knee Replacement System in conjunction with an iPoly XE insert. The study will include a minimum of 50 subjects and a maximum of 60 subjects at a single center. The study site will be located in Germany. The study subjects will be followed for 10 years post implant.
- Conditions
- Knee Osteoarthritis
- Being tested
- iPoly XE tibial insert with ConforMIS iTotal KRS
- Keywords
- knee implant, osteoarthritis, patient-specific, knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPoly XE tibial insert with ConforMIS iTotal KRSDevice
The implants are constructed to conform to the surface of the patient's femoral condyle and proximal tibia, replacing the damaged cartilage with a smooth articulating surface. The femoral component and tibial tray are manufactured from cobalt chromium molybdenum alloy. The tibial insert and patellar component are manufactured from ultra-high molecular weight polyethylene.
| Study group | Role | What they receive |
|---|---|---|
| ConforMIS iTotal Knee with iPoly Insert | Experimental | The tibial insert being utilized in this study will be a highly-crosslinked, Vitamin-E enriched UHMWPE (iPoly XE) instead of traditional tibial inserts. Receives: Device: iPoly XE tibial insert with ConforMIS iTotal KRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Device-related Complications
Adverse events were categorized as "Device Probably Related", "Device Possibly Related", Device All Related", or "Device Not Related" by the care team for all adverse events (as per the definitions of adverse events on clinicaltrials.gov). Outcome metrics are given in the form of "Events per Patient" which was calculated by dividing the number of adverse in each category by the number of baseline patients.
Measured: 1 year
Incidence of Procedure-Related Complications
Adverse events were categorized as "Procedure Probably Related", "Procedure Possibly Related", Procedure All Related", or "Procedure Not Related" by the care team for all adverse events (as per the definitions of adverse events on clinicaltrials.gov). Outcome metrics are given in the form of "Events per Patient" which was calculated by dividing the number of adverse in each category by the number of baseline patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start24 Jan 2018
- Primary completion9 Jun 2022
- Study completion9 Jun 2022
Why it stopped: Decision of investigational team
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restor3D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philipp Drees, Principal investigator, University- Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289754
- Sponsor's protocol ID
- 16-001
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2017
- Last updated
- 16 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System and iPoly XE Tibial Inserts
- ClinicalTrials.gov ID
- NCT03289754
- Acronym / sponsor ID
- 16-001
- Conditions
- Knee Osteoarthritis
- Keywords
- knee implant, osteoarthritis, patient-specific, knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision of investigational team
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 21 Sep 2017 (actual)
- Results
- Posted 16 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the clinical outcomes of subjects who have recently undergone surgery with the iTotal® Cruciate Retaining (CR) Total Knee Replacement System (KRS) who have also had iPoly XE Tibial Inserts implanted.
Detailed description
The study is prospective and single-center. Subjects will be implanted with an iTotal® CR Knee Replacement System in conjunction with an iPoly XE insert. The study will include a minimum of 50 subjects and a maximum of 60 subjects at a single center. The study site will be located in Germany. The study subjects will be followed for 10 years post implant.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ConforMIS iTotal Knee with iPoly Insert | Experimental | Device: iPoly XE tibial insert with ConforMIS iTotal KRSThe tibial insert being utilized in this study will be a highly-crosslinked, Vitamin-E enriched UHMWPE (iPoly XE) instead of traditional tibial inserts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical condition included in the approved Indications For Use for the iTotal® CR
- Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment.
- Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
- > 18 years of age
Key exclusion criteria (21 listed)
- Simultaneous bilateral procedure required
- BMI > 40
- Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
- Poorly controlled diabetes
- Neuromuscular conditions which prevent patient from participating in study activities
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 |
|---|---|---|
| iPoly XE tibial insert with ConforMIS iTotal KRSThe implants are constructed to conform to the surface of the patient's femoral condyle and proximal tibia, replacing the damaged cartilage with a smooth articulating surface. The femoral component and tibial tray are manufactured from cobalt chromium molybdenum alloy. The tibial insert and patellar component are manufactured from ultra-high molecular weight polyethylene. | Device | ConforMIS iTotal Knee with iPoly Insert |
Primary outcome
Incidence of Device-related Complications
Time frame: 1 year
Adverse events were categorized as "Device Probably Related", "Device Possibly Related", Device All Related", or "Device Not Related" by the care team for all adverse events (as per the definitions of adverse events on clinicaltrials.gov). Outcome metrics are given in the form of "Events per Patient" which was calculated by dividing the number of adverse in each category by the number of baseline patients.
Incidence of Procedure-Related Complications
Time frame: 1 year
Adverse events were categorized as "Procedure Probably Related", "Procedure Possibly Related", Procedure All Related", or "Procedure Not Related" by the care team for all adverse events (as per the definitions of adverse events on clinicaltrials.gov). Outcome metrics are given in the form of "Events per Patient" which was calculated by dividing the number of adverse in each category by the number of baseline patients.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Study Comparing Osteoarthritis Programs
Osteoarthritis
Recruiting
Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Knee Arthritis, Osteoarthritis
RecruitingObservational study
SVF Cellular Composition, Secretome, and Responses in Knee Osteoarthritis
Osteoarthritis, Knee
Recruiting
Pharmacist-physiotherapist Collaborative Management for Early Knee Osteoarthritis
Osteoarthritis (OA) of the Knee, Physiotherapy
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
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.
Philipp Drees principal investigator
University- Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPoly XE tibial insert with ConforMIS iTotal KRS in people with Knee Osteoarthritis, run by Restor3D at 1 site in Germany.
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 4 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: stopped early, as of the sponsor's last update on 16 Oct 2025. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 16 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Device-related Complications (time frame: 1 year). The study lists 2 primary outcomes in all. 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 16 Oct 2025.