Osteoarthritis, KneeNCT04667559
A Study to Evaluate the Conformis iTotal Identity Knee Replacement System
An observational study of Osteoarthritis, Knee, run by Restor3D at 2 sites in United States.
Trial summary
This is a prospective multicenter study located in the United States. Subjects will be implanted with an iTotal Identity Knee Replacement System and followed for 10 years post implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Conformis iTotal Identity Knee Replacement System
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Oct 2020to 14 Dec 2022
- 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
- Adult, Older adult
Study population: Patients with clinical condition indicated in the approved Instructions for Use for the Conformis iTotal Identity Knee Replacement System
Who may be able to join
- Clinical condition included in the approved Indications For Use for the iTotal Identity CR KRS
- 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 with complete development of musculoskeletal structures
Who cannot join
- Simultaneous bilateral procedure required
- BMI > 40
- Active malignancy (defined as a history of any invasive malignancy - except nonmelanoma skin cancer), unless subject 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 (defined as HbA1c >7 or Investigator discretion)
- Neuromuscular conditions which prevent subject from participating in study activities
- Active local or systemic infection which precludes TKR procedure
Show all 22Show fewer
- Immunocompromised in the opinion of the Investigator
- Medically diagnosed fibromyalgia or similar conditions that might impact the subject's ability to differentiate source of pain
- 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 that is likely to confound results in the opinion of the Investigator
- Other physical disability affecting the hips, spine, or contralateral knee that is likely to confound results in the opinion of the Investigator
- 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
- Pregnant or planning to become pregnant prior to study TKR procedure (in case of pregnancy after study TKR procedure, eligibility to continue with the protocol will be reviewed)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Personalized Orthopedic Research Institute
Boynton Beach, Florida, 33437
Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37203
About this study
Official title: A Prospective, Multicenter Study to Evaluate the Conformis iTotal Identity Knee Replacement System
This is a prospective multicenter study located in the United States. Subjects will be implanted with an iTotal Identity Knee Replacement System and followed for 10 years post implantation.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Conformis iTotal Identity Knee Replacement System
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conformis iTotal Identity Knee Replacement SystemDevice
The iTotal® Identity KRS is a tri-compartmental semi-constrained knee prosthesis composed of three components: a Femoral Component, a Tibial Component, and a Patellar Component.Using patient imaging, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of a cemented metallic device designed from the patient's natural bone geometry. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and function
Measured by 2011 Knee Society Clinical Rating Score (objective knee score 0-125, function score 0-100, satisfaction score 0-40, expectation score 0-15 with higher scores meaning better outcome)
Measured: 2 years post implantation
Secondary outcomes (8)
Revision rate
Measured: Post implantation up to 10 years
Incidence of major procedure-related and device-related complications, including infection rate
Measured: Post implantation up to 10 years
Post-operative hip-knee-ankle limb alignment (with 180 degrees being the expected outcome, plus or minus 5 degrees), if long leg x-rays available
Measured: Post implantation up to 10 years
Number of patients demonstrating radiographic loosening, radiolucency
Review of x-rays to subjectively determine evidence of implant disassociation with bone
Measured: Post implantation up to 10 years
Length of procedure
Measured: Implant procedure from time the patient enters the operating room til time the surgery is complete and patient exits the operating room (up to 6 hours)
Length of hospital stay in hours
Measured: Time from patient admission to hospital before surgery til discharge from hospital (up to 72 hours)
blood loss during surgery
Measured: Implant procedure from time the patient enters the operating room til time the surgery is complete and patient exits the operating room (up to 6 hours)
blood transfusion rates
Measured: Implant procedure from time the patient enters the operating room til time the surgery is complete and patient exits the operating room (up to 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start12 Oct 2020
- Primary completion14 Dec 2022
- Study completion14 Dec 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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restor3D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667559
- Sponsor's protocol ID
- 20-001
- Status last verified
- Oct 2023
- First submitted
- 9 Nov 2020
- Last updated
- 25 Oct 2023
- Results posted
- No
- 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 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study to Evaluate the Conformis iTotal Identity Knee Replacement System
- ClinicalTrials.gov ID
- NCT04667559
- Acronym / sponsor ID
- 20-001
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Decision of investigational team
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 14 Dec 2020 (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 multicenter study located in the United States. Subjects will be implanted with an iTotal Identity Knee Replacement System and followed for 10 years post implantation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical condition indicated in the approved Instructions for Use for the Conformis iTotal Identity Knee Replacement System
Key inclusion criteria (4 listed)
- Clinical condition included in the approved Indications For Use for the iTotal Identity CR KRS
- 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 with complete development of musculoskeletal structures
Key exclusion criteria (22 listed)
- Simultaneous bilateral procedure required
- BMI > 40
- Active malignancy (defined as a history of any invasive malignancy - except nonmelanoma skin cancer), unless subject 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 (defined as HbA1c >7 or Investigator discretion)
- Neuromuscular conditions which prevent subject 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 |
|---|---|---|
| Conformis iTotal Identity Knee Replacement SystemThe iTotal® Identity KRS is a tri-compartmental semi-constrained knee prosthesis composed of three components: a Femoral Component, a Tibial Component, and a Patellar Component.Using patient imaging, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of a cemented metallic device designed from the patient's natural bone geometry. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation. | Device | – |
Primary outcome
Pain and function
Time frame: 2 years post implantation
Measured by 2011 Knee Society Clinical Rating Score (objective knee score 0-125, function score 0-100, satisfaction score 0-40, expectation score 0-15 with higher scores meaning better outcome)
8 secondary outcomes
Revision rate
Time frame: Post implantation up to 10 years
Incidence of major procedure-related and device-related complications, including infection rate
Time frame: Post implantation up to 10 years
Post-operative hip-knee-ankle limb alignment (with 180 degrees being the expected outcome, plus or minus 5 degrees), if long leg x-rays available
Time frame: Post implantation up to 10 years
Number of patients demonstrating radiographic loosening, radiolucency
Time frame: Post implantation up to 10 years
Length of procedure
Time frame: Implant procedure from time the patient enters the operating room til time the surgery is complete and patient exits the operating room (up to 6 hours)
Length of hospital stay in hours
Time frame: Time from patient admission to hospital before surgery til discharge from hospital (up to 72 hours)
blood loss during surgery
Time frame: Implant procedure from time the patient enters the operating room til time the surgery is complete and patient exits the operating room (up to 6 hours)
blood transfusion rates
Time frame: Implant procedure from time the patient enters the operating room til time the surgery is complete and patient exits the operating room (up to 6 hours)
Results and safety
The study was stopped early (reason given: Decision of investigational team). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Restor3D at 2 sites 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 4 inclusion and 22 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 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Decision of investigational team). Results are not available in the source record.
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?
Pain and function (time frame: 2 years post implantation). 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 25 Oct 2023.