Osteoarthritis of the KneeNCT01820650
A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System
An observational study of Osteoarthritis of the Knee, run by Restor3D at 9 sites in United States.
Trial summary
This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- iTotal G2 CR Knee Replacement System
- Type of treatment
- Medical device
- How many people
- 359 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2013to Oct 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with osteoarthritis of the knee
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 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 > 15 º
- Fixed flexion contracture ≥ 15 º
- 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
9 sites in 1 country.
9 sites in 1 country
United States9 sites
JFK Medical Center
Atlantis, Florida, 33462
EMMC - Orthopaedic Surgery of Maine
Bangor, Maine, 04401
Great Lakes Bone and Joint
Battle Creek, Michigan, 49015
Advanced Orthopedics and Sports Medicine
Cypress, Texas, 77429
Orthopaedic Instatute of Henderson
Henderson, Nevada, 89052
Joint Replacement Associates
Houston, Texas, 77030
Desert Orthopedic Center
Las Vegas, Nevada, 89121
Mansfield Orthopaedics
Morrisville, Vermont, 05661
Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37203
About this study
This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.
Read the detailed description
If the patient has previously received a standard total knee replacement in their contralateral knee, the primary endpoint questionnaire and some secondary endpoint questionnaires will be completed regarding BOTH their iTotal® CR knee and their standard total knee for all time points where questionnaires are required by the protocol.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- iTotal G2 CR Knee Replacement System
- Keywords
- osteoarthritis, knee replacement, patient-specific
- 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.
iTotal G2 CR Knee Replacement SystemDevice
Total Knee replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
2011 Knee Society Score
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 posted29 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2017
- Study completionOct 2023
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 of the 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restor3D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Quartulli, Study director, Restor3DTerry Clyburn, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820650
- Sponsor's protocol ID
- 12-001
- Status last verified
- Oct 2023
- First submitted
- 26 Mar 2013
- 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® (CR) Knee Replacement System
- ClinicalTrials.gov ID
- NCT01820650
- Acronym / sponsor ID
- 12-001
- Conditions
- Osteoarthritis of the Knee
- Keywords
- osteoarthritis, knee replacement, patient-specific
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Decision of investigational team
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Study start
- Feb 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Oct 2023 (actual)
- First posted
- 29 Mar 2013 (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 study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.
Detailed description
If the patient has previously received a standard total knee replacement in their contralateral knee, the primary endpoint questionnaire and some secondary endpoint questionnaires will be completed regarding BOTH their iTotal® CR knee and their standard total knee for all time points where questionnaires are required by the protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with osteoarthritis of the knee
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 |
|---|---|---|
| iTotal G2 CR Knee Replacement SystemTotal Knee replacement | Device | – |
Primary outcome
2011 Knee Society Score
Time frame: 1 Year
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.
Marc Quartulli study director
Restor3D
Terry Clyburn, MD principal investigator
The University of Texas Health Science Center, Houston
9 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 of the Knee, run by Restor3D at 9 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 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 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 9 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?
2011 Knee Society Score (time frame: 1 Year). 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; AzTrials last refreshed its copy on 28 Oct 2026.