Bicompartmental OsteoarthritisNCT01564641
Study of the ConforMIS iDuo(R) G2
An observational study of Bicompartmental Osteoarthritis, run by Restor3D at 3 sites in United States.
Trial summary
To evaluate the ConforMIS iDuo G2 implant Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bicompartmental Osteoarthritis
- What is being tested?
- iDuo G2
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2012to 18 Nov 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting this specific form of osteoarthritis at participating sites with IRB approval.
Who may be able to join
- Clinical condition included in the approved Indications For Use for the iDuo® G2
- Bicompartmental osteoarthritis defined as Medial and patellofemoral osteoarthritis, or Lateral and patellofemoral arthritis as confirmed by the investigator's assessment of disease status at screening visit. Disease status is assessed by Clinical and Radiographic assessment. In addition, CT arthrogram assessment may be utilized for diagnosis.
- 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
- 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
- Immunocompromised
Show all 21Show fewer
- 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 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
- Compromised ACL, PCL or collateral ligament
- Severe fixed valgus or varus deformity of >15º
- Extensor lag > 15 º
- Fixed flexion contracture ≥ 10 º
- Prior history of failed implant surgery of the joint to be treated, including high tibial osteotomy (HTO)
- Unwilling or unable to comply with study requirements
- Participation in another clinical study which would confound results
- If during intra-op, it is noted that the patient has tri-compartmental disease, then the patient is considered a screen fail
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mansfield Orthopaedics
Morrisville, Vermont, 05661
Forest Ridge Medical Pavilion
New Castle, Indiana, 47362
Ochsner Sports Medicine Institute
New Orleans, Louisiana, 70121
About this study
Official title: A Prospective, Multicenter Study of the ConforMIS iDuo(R) G2 Bicompartmental Knee Repair System
To evaluate the ConforMIS iDuo G2 implant
Read the detailed description
This is a prospective, multicenter study. The investigators will be evaluating the ConforMIS iDuo G2 implant.
- Conditions
- Bicompartmental Osteoarthritis
- Being tested
- iDuo G2
- Keywords
- knee, osteoarthritis, bicompartmental, arthroplasty, joint diseases
- Medical subject headings
- Osteoarthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iDuo G2Device
single comparator
| Study group | Role | What they receive |
|---|---|---|
| iDuo G2 | iDuo G2 to be implanted in the patient. Receives: Device: iDuo G2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and function
By using questionnaires, we will look at pain and function scores at this time point
Measured: 3 months
Secondary outcomes (10)
Pain and function at follow up time points
By using questionnaires, we will look at pain and function scores at these time points
Measured: 1, 2, 5 and 10 years post implant
Revision rates
Capture revision rates
Measured: Patient will be observed for 10 years post implant
Incidence of major procedure related and device related complications
To capture any procedure or device related complications
Measured: Patient will be observed for 10 years post implant
Post operative limb alignment
Measured: X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups
Radiographic implant position
Measured: X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups
Radiographic loosening, radiolucencies
Measured: X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups
Length of procedure
Timing from skin to cement
Measured: Day of surgery
Length of hospital stay
measure length of stay from admission to discharge
Measured: Patient will be followed from admission to discharge with an average of about 5 days
Blood loss during surgery
Measured: Day of surgery
Intraoperative blood replacement volume
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2016
- Study completion18 Nov 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 Bicompartmental 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Restor3D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- L Rolston, MD, Principal investigator, Forest Ridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564641
- Sponsor's protocol ID
- 11-001
- Status last verified
- Oct 2023
- First submitted
- 12 Mar 2012
- 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 of the ConforMIS iDuo(R) G2 Bicompartmental Knee Repair System
- ClinicalTrials.gov ID
- NCT01564641
- Acronym / sponsor ID
- 11-001
- Conditions
- Bicompartmental Osteoarthritis
- Keywords
- knee, osteoarthritis, bicompartmental, arthroplasty, joint diseases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Decision of investigational team
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Study start
- May 2012 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 28 Mar 2012 (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.
To evaluate the ConforMIS iDuo G2 implant
Detailed description
This is a prospective, multicenter study. The investigators will be evaluating the ConforMIS iDuo G2 implant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iDuo G2 | – | Device: iDuo G2iDuo G2 to be implanted in the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting this specific form of osteoarthritis at participating sites with IRB approval.
Key inclusion criteria (4 listed)
- Clinical condition included in the approved Indications For Use for the iDuo® G2
- Bicompartmental osteoarthritis defined as Medial and patellofemoral osteoarthritis, or Lateral and patellofemoral arthritis as confirmed by the investigator's assessment of disease status at screening visit. Disease status is assessed by Clinical and Radiographic assessment. In addition, CT arthrogram assessment may be utilized for diagnosis.
- 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)
- 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
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 |
|---|---|---|
| iDuo G2single comparator | Device | iDuo G2 |
Primary outcome
Pain and function
Time frame: 3 months
By using questionnaires, we will look at pain and function scores at this time point
10 secondary outcomes
Pain and function at follow up time points
Time frame: 1, 2, 5 and 10 years post implant
Revision rates
Time frame: Patient will be observed for 10 years post implant
Incidence of major procedure related and device related complications
Time frame: Patient will be observed for 10 years post implant
Post operative limb alignment
Time frame: X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups
Radiographic implant position
Time frame: X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups
Radiographic loosening, radiolucencies
Time frame: X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups
Length of procedure
Time frame: Day of surgery
Length of hospital stay
Time frame: Patient will be followed from admission to discharge with an average of about 5 days
Blood loss during surgery
Time frame: Day of surgery
Intraoperative blood replacement volume
Time frame: Day of surgery
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
Related trials for Bicompartmental Osteoarthritis
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Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement
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Clinical Outcomes of Joint Arthroplasty
Osteoarthritis, Knee
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.
L Rolston, MD principal investigator
Forest Ridge
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bicompartmental Osteoarthritis, run by Restor3D at 3 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 3 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: 3 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 25 Oct 2023.