Knee OsteoarthritisNCT01820676
iUni G2+ Prospective Study
An observational study of Knee Osteoarthritis, run by Restor3D at 1 site in United Kingdom.
Trial summary
This study is designed to monitor long term clinical outcomes of the iUni G2+ unicompartmental knee replacement 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?
- iUni G2+
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jul 2013to 14 Oct 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 with knee osteoarthritis
Who may be able to join
- Clinical condition included in the approved Indications For Use
- Unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment
- 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 > 35
- Treatment for cancer within the past 5 years, with the exception of skin cancer
- Poorly controlled diabetes
- Neuromuscular conditions which prevent patient from participating in study activities
- Active local or systemic infection
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- Immunocompromised
- Fibromyalgia or other general body pain related condition
- Advanced tricompartmental osteoarthritis
- Symptomatic patellofemoral disease
- Rheumatoid arthritis or other forms of inflammatory joint disease (excluding Gout unless it is in the treated knee or limiting overall function)
- Loss of bone or musculature, osteoporosis, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified. Osteoporosis is defined by more than -2.5 standard deviations from the T score as measured on a Dual Energy X-Ray Absortiometry Scan (DEXA) within 2 years of surgery.
- Advanced loss of osteochondral structure on the affected femoral condyle
- Compromised ACL, PCL or collateral ligament
- Severe (>15º) fixed valgus or varus deformity
- Extension deficit > 15 º
- Prior history of failed implant surgery of the joint to be treated
- Unwilling or unable to comply with study requirements
- Participation in another clinical study which would confound results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multi-Center Study to Evaluate the ConforMIS iUni® G2+ Unicompartmental Knee Resurfacing Device
This study is designed to monitor long term clinical outcomes of the iUni G2+ unicompartmental knee replacement
Read the detailed description
The study subjects will be followed for 10 years post implant. The follow-up visit schedule will include visits at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post implant.
- Conditions
- Knee Osteoarthritis
- Being tested
- iUni G2+
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iUni G2+Device
The iUni G2+ Unicompartmental Resurfacing Device (iUni) is an FDA cleared and CE Marked implant designed for patients with damage isolated to either the medial or lateral tibiofemoral compartment of the knee. The patient-specific iUni is designed from a CT scan of an individual patient's knee using a design process which interactively maps the diseased area and defines the extent of misalignment present in the knee. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation (Fitz).
| Study group | Role | What they receive |
|---|---|---|
| iUni G2+ | iUni G2+ in all patients Receives: Device: iUni G2+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
2011 Knee Society Score
Measured: 1 Year
KOOS Score
Measured: 1 Year
Oxford Knee 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 start15 Jul 2013
- Primary completion1 Jul 2017
- Study completion14 Oct 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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restor3D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dinesh Nathwani, MD, Principal investigator, The London Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820676
- Sponsor's protocol ID
- 12-004
- Status last verified
- Oct 2023
- First submitted
- 26 Mar 2013
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- 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, Multi-Center Study to Evaluate the ConforMIS iUni® G2+ Unicompartmental Knee Resurfacing Device
- ClinicalTrials.gov ID
- NCT01820676
- Acronym / sponsor ID
- 12-004
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Decision of investigational team
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2013 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 14 Oct 2022 (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 monitor long term clinical outcomes of the iUni G2+ unicompartmental knee replacement
Detailed description
The study subjects will be followed for 10 years post implant. The follow-up visit schedule will include visits at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post implant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iUni G2+ | – | Device: iUni G2+iUni G2+ in all patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with knee osteoarthritis
Key inclusion criteria (4 listed)
- Clinical condition included in the approved Indications For Use
- Unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment
- 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 (19 listed)
- Simultaneous bilateral procedure required
- BMI > 35
- Treatment for cancer within the past 5 years, with the exception of skin cancer
- 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 |
|---|---|---|
| iUni G2+The iUni G2+ Unicompartmental Resurfacing Device (iUni) is an FDA cleared and CE Marked implant designed for patients with damage isolated to either the medial or lateral tibiofemoral compartment of the knee. The patient-specific iUni is designed from a CT scan of an individual patient's knee using a design process which interactively maps the diseased area and defines the extent of misalignment present in the knee. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation (Fitz). | Device | iUni G2+ |
Primary outcome
2011 Knee Society Score
Time frame: 1 Year
KOOS Score
Time frame: 1 Year
Oxford Knee 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.
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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.
Dinesh Nathwani, MD principal investigator
The London Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Restor3D at 1 site in United Kingdom.
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 19 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 1 site in United Kingdom. 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). The study lists 3 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 25 Oct 2023.