Early Stage Osteoarthritis of the CMC-1 JointNCT01961570
Clinical Evaluation of the Articulinx InterCarpoMetacarpal Cushion (ICMC)for Osteoarthritis of the First CarpoMetacarpal Joint
An observational study of Early Stage Osteoarthritis of the CMC-1 Joint, run by Articulinx at 1 site in Netherlands.
Trial summary
This study is to evaluate the performance of the Articulinx ICMC (InterCarpoMetacarpalCushion)in the carpometacarpal joint (CMC joint) and to describe the clinical results in patients who have been treated with this device. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Early Stage Osteoarthritis of the CMC-1 Joint
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2013to Jul 2016
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women with early stage carpometacarpal-1 (CMC-1)joint osteoarthrititis.
Who may be able to join
- Patient is diagnosed by the investigator to be medically acceptable for a surgical procedure?
- Patient is aged 40 to 75 inclusive?
- Patient has symptomatic osteoarthritis of the carpometacarpal (CMC-1) joint as demonstrated by a minimum DASH score of 40 at baseline?
- Patient has pain in the target CMC joint as demonstrated by an average VAS pain score greater than or equal to 40 at baseline on a 100mm VAS?
- Patient has radiographic evidence of Stage II OA with no free-floating bodies in the CMC-1 joint?
- Radiographic Stage II OA is defined according to the Eaton-Glickel classification system (based upon lateral view) as follows:
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- "Slight narrowing of the TM [trapezio-metacarpal/CMC] joint will be present with minimal sclerotic changes of the subchondral bone. There may be joint debris not exceeding 2 mm in diameter in the form of osteophytes or loose bodies The ST [scapho-trapzeial joint] should appear normal."
- Patient has subluxation of less than one-third of the target CMC joint?
- Patient agrees to return to the clinic for follow-up visits at the required times per protocol and follow the requirements of this protocol?
- Patient is able and willing to provide voluntary consent to participate?
Who cannot join
- Patient has non-symptomatic osteoarthritis of the first CMC joint?
- Patient has small bone or calcific fragments (spurs, osteophytes) in the target CMC joint greater than two millimeters (>2mm) in diameter?
- Patient has free floating bodies of any size within the target CMC joint?
- Patient has radiographic/imaging evidence of significant osteoarthritic changes within the first metacarpal, or scaphotrapezotrapezoidal (STT) joint of the target wrist consistent with Stage III/IV OA, according to Eaton-Glickel, as defined below?
- "Stage III OA: The joint space will be markedly narrowed or obliterated with cystic changes, sclerotic bone, varying degrees of dorsal subluxation, and joint debris exceeding 2 mm in diameter. The ST joint will appear normal."
- "Stage IV OA: There is complete deterioration of the TM [CMC] joint as in stage III and, in addition, the ST joint will be narrowed with sclerotic and cystic changes apparent."
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- Patient has concomitant musculoskeletal pathology of the target hand, such as carpal tunnel syndrome, palmar tenosynovitis, scaphoulnate ligament instability/degeneration, ulnocarpal impaction syndrome, or trigger finger;
- Patient has concomitant rheumatic disease (e.g., inflammatory rheumatoid arthritis, cutaneous psoriasis, polyarticular chondrocalcinosis, gout, fibromyalgia) or exhibits signs of metabolic disorders affecting the bone or joint (e.g., osteoporosis, osteomalacia, hyper- or hypo-parathyroidism, Paget's disease)?
- Patient has an active infection, sepsis or osteomyelitis?
- Patient has skin disease or eruption at the CMC target site?
- Patient had previous surgery on the target CMC joint or on the wrist of the target hand?
- Patient had significant injury to the target CMC joint within the 6 months prior to study enrollment or a significant permanent injury at any time prior to study enrollment?
- Patient has a significant comorbid medical condition that could exacerbate pain symptoms or adversely affect physical functioning or healing of the thumb CMC joint (e.g. de Quervains disease, Ehlers-Danlos Syndrome, Complex Regional Pain Syndrome)?
- Patient has had corticosteroid injections in the target CMC joint within 6 months prior to study enrollment?
- Patient takes concomitant immunosuppressive therapy (e.g., oral/injectable glucocorticoids, alkylating agents, antimetabolites, antibodies, drugs acting on immunophilins [Ciclosporin, Sirolimus], interferons, opioids) that could adversely affect healing?
- Patient has uncontrolled diabetes mellitus?
- Patient takes anticoagulation and or antiplatelet therapy that cannot be stopped prior to surgery?
- Patient is planning a pregnancy, or patient is pregnant and/or lactating? (If a subject becomes pregnant after enrollment in the study, then the subject will continue to be followed, even though she may miss some follow-up appointments. During the pregnancy, X-rays will not be performed.)
- Patient is participating in any other clinical investigation that could impact the outcome of this study?
- Patient has a known history of drug or alcohol abuse in the previous 12 months?
- Patient has a history of, or is currently engaged in, litigation for musculoskeletal injuries or disorders or medical malpractice?
- Patient has other life circumstances that the Investigator feels would interfere with study participation such as planned relocation, difficulty complying with schedule of study follow-up visits, is generally uncooperative?
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Articulinx InterCarpoMetacarpal Cushion (ICMC) for Osteoarthritis of the First CarpoMetacarpal Joint: A New Study of the ICMC in a Clinical Setting
This study is to evaluate the performance of the Articulinx ICMC (InterCarpoMetacarpalCushion)in the carpometacarpal joint (CMC joint) and to describe the clinical results in patients who have been treated with this device. Expected results include the relief of symptoms and improvement of function in patients with symptomatic osteoarthritis (OA) of the CMC-1 joint. Evaluation of device performance will be achieved through measurements of pain, pain medication use, and joint function in up to 20 subjects. Each subject will be compared to their pre-surgery status for each endpoint.
Read the detailed description
The Articulinx ICMC is a minimally invasive orthopedic device intended to be implanted into the basilar, or first carpometacarpal (CMC) joint, as an interpositional spacer between the first metacarpal and trapezium bones. The device is intended to be used in the treatment of thumb disabilities resulting from osteoarthritis of the CMC-1 joint.
The Articulinx ICMC is a molded polymer disc with an encapsulated radiopaque marker. The Articulinx ICMC is designed to be an inter-positional spacer for the treatment of symptoms of early-stage osteoarthritis of the first CMC joint. When properly positioned in the joint, the ICMC can preserve or restore normal space between the trapezium and thumb metacarpal bones in the first CMC joint. The restoration of natural spacing and biomechanics within the joint is expected to reduce pain and restore strength and function.
The ICMC is designed to be implanted earlier in the OA disease process than other basilar joint implants. The ICMC allows a more active lifestyle and may reduce or eliminate the need for long-term use of prescribed arthritis medications. Because the ICMC procedure does not remove supportive bone or tissue, the procedure is reversible and treatment options for later stage disease progression remain available to patients.
The ICMC was first placed on the EU (European Union) market by the Sponsor in April, 2011 following approval to carry the CE (European Community) Mark based upon successful pre-clinical and clinical testing. In other clinical studies, one single site study and one multicenter site study, both conducted in accordance with ISO 14155 (International Standards Organization), the 1-year enrollment is completed and 2-year follow-up is ongoing.
The primary objective of this study is to document the safety of the Articulinx ICMC by evaluating Incidence of unanticipated device and procedure related adverse events intra-operatively, and through one year follow-up.
The secondary objectives of this study are to describe clinical and radiographic outcomes in patients who are treated with the device.
This is a single site study in The Netherlands. Study enrollment will begin following required regulatory submissions/Ethics Committee approval and after site study personnel training is completed. The study will be conducted in conformance with ISO 14155 and will evaluate the performance of the Articulinx ICMC for the relief of the symptoms of osteoarthritis in the CMC-1 joint. Primary and secondary study endpoints will be evaluated through one year and patients will continue to be followed for two years for evaluation of longer-term performance.
- Keywords
- Early stage hand osteoarthritis, Carpometacarpal osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study is the Incidence of unanticipated device and procedure related adverse events.
Reported incidence of unanticipated device and procedure related Adverse Events will be documented at all scheduled visits and within 24 hours of knowledge of an event.
Measured: Intra-operatively and through one year follow-up.
Secondary outcomes (4)
Secondary outcome measures describe clinical and radiographic outcomes in patients treated with the device.
Changes in CMC-1 joint function post-procedure compared to preoperative baseline
Measured: Post operative follow-up at 3mo, 6mo, and 12mo
Secondary outcome measures describe clinical and radiographic outcomes in patients treated with the device.
Changes in average CMC-1 joint pain score at the one-year postoperative follow-up compared to preoperative baseline
Measured: Post operative follow-up at 3mo, 6mo, and 12mo
Secondary outcome measures describe clinical and radiographic outcomes in patients treated with the device.
Change in DASH scores post-procedure as compared to preoperative baseline
Measured: Post operative follow-up at 3mo, 6mo, and 12mo.
Secondary outcome measures describe clinical and radiographic outcomes in patients treated with the device.
Maintenance of trapezial joint space height compared to pre-operative baseline
Measured: Postoperative follow-up at 3mo, 6mo, and 12mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Osteoarthritis of the CMC-1 JointStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Articulinx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Marco J.P.F. Ritt, MD, PhD, Principal investigator, Vrij University (VU) Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961570
- Sponsor's protocol ID
- CL 0031
- Status last verified
- Oct 2013
- First submitted
- 9 Oct 2013
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Articulinx InterCarpoMetacarpal Cushion (ICMC) for Osteoarthritis of the First CarpoMetacarpal Joint: A New Study of the ICMC in a Clinical Setting
- ClinicalTrials.gov ID
- NCT01961570
- Acronym / sponsor ID
- CL 0031
- Keywords
- Early stage hand osteoarthritis, Carpometacarpal osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ArticulinxIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 11 Oct 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 to evaluate the performance of the Articulinx ICMC (InterCarpoMetacarpalCushion)in the carpometacarpal joint (CMC joint) and to describe the clinical results in patients who have been treated with this device. Expected results include the relief of symptoms and improvement of function in patients with symptomatic osteoarthritis (OA) of the CMC-1 joint. Evaluation of device performance will be achieved through measurements of pain, pain medication use, and joint function in up to 20 subjects. Each subject will be compared to their pre-surgery status for each endpoint.
Detailed description
The Articulinx ICMC is a minimally invasive orthopedic device intended to be implanted into the basilar, or first carpometacarpal (CMC) joint, as an interpositional spacer between the first metacarpal and trapezium bones. The device is intended to be used in the treatment of thumb disabilities resulting from osteoarthritis of the CMC-1 joint.
The Articulinx ICMC is a molded polymer disc with an encapsulated radiopaque marker. The Articulinx ICMC is designed to be an inter-positional spacer for the treatment of symptoms of early-stage osteoarthritis of the first CMC joint. When properly positioned in the joint, the ICMC can preserve or restore normal space between the trapezium and thumb metacarpal bones in the first CMC joint. The restoration of natural spacing and biomechanics within the joint is expected to reduce pain and restore strength and function.
The ICMC is designed to be implanted earlier in the OA disease process than other basilar joint implants. The ICMC allows a more active lifestyle and may reduce or eliminate the need for long-term use of prescribed arthritis medications. Because the ICMC procedure does not remove supportive bone or tissue, the procedure is reversible and treatment options for later stage disease progression remain available to patients.
The ICMC was first placed on the EU (European Union) market by the Sponsor in April, 2011 following approval to carry the CE (European Community) Mark based upon successful pre-clinical and clinical testing. In other clinical studies, one single site study and one multicenter site study, both conducted in accordance with ISO 14155 (International Standards Organization), the 1-year enrollment is completed and 2-year follow-up is ongoing.
The primary objective of this study is to document the safety of the Articulinx ICMC by evaluating Incidence of unanticipated device and procedure related adverse events intra-operatively, and through one year follow-up.
The secondary objectives of this study are to describe clinical and radiographic outcomes in patients who are treated with the device.
This is a single site study in The Netherlands. Study enrollment will begin following required regulatory submissions/Ethics Committee approval and after site study personnel training is completed. The study will be conducted in conformance with ISO 14155 and will evaluate the performance of the Articulinx ICMC for the relief of the symptoms of osteoarthritis in the CMC-1 joint. Primary and secondary study endpoints will be evaluated through one year and patients will continue to be followed for two years for evaluation of longer-term performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women with early stage carpometacarpal-1 (CMC-1)joint osteoarthrititis.
Key inclusion criteria (10 listed)
- Patient is diagnosed by the investigator to be medically acceptable for a surgical procedure?
- Patient is aged 40 to 75 inclusive?
- Patient has symptomatic osteoarthritis of the carpometacarpal (CMC-1) joint as demonstrated by a minimum DASH score of 40 at baseline?
- Patient has pain in the target CMC joint as demonstrated by an average VAS pain score greater than or equal to 40 at baseline on a 100mm VAS?
- Patient has radiographic evidence of Stage II OA with no free-floating bodies in the CMC-1 joint?
Key exclusion criteria (22 listed)
- Patient has non-symptomatic osteoarthritis of the first CMC joint?
- Patient has small bone or calcific fragments (spurs, osteophytes) in the target CMC joint greater than two millimeters (>2mm) in diameter?
- Patient has free floating bodies of any size within the target CMC joint?
- Patient has radiographic/imaging evidence of significant osteoarthritic changes within the first metacarpal, or scaphotrapezotrapezoidal (STT) joint of the target wrist consistent with Stage III/IV OA, according to Eaton-Glickel, as defined below?
- "Stage III OA: The joint space will be markedly narrowed or obliterated with cystic changes, sclerotic bone, varying degrees of dorsal subluxation, and joint debris exceeding 2 mm in diameter. The ST joint will appear normal."
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint of this study is the Incidence of unanticipated device and procedure related adverse events.
Time frame: Intra-operatively and through one year follow-up.
Reported incidence of unanticipated device and procedure related Adverse Events will be documented at all scheduled visits and within 24 hours of knowledge of an event.
4 secondary outcomes
Secondary outcome measures describe clinical and radiographic outcomes in patients treated with the device.
Time frame: Post operative follow-up at 3mo, 6mo, and 12mo
Secondary outcome measures describe clinical and radiographic outcomes in patients treated with the device.
Time frame: Post operative follow-up at 3mo, 6mo, and 12mo
Secondary outcome measures describe clinical and radiographic outcomes in patients treated with the device.
Time frame: Post operative follow-up at 3mo, 6mo, and 12mo.
Secondary outcome measures describe clinical and radiographic outcomes in patients treated with the device.
Time frame: Postoperative follow-up at 3mo, 6mo, and 12mo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
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.
Prof. Marco J.P.F. Ritt, MD, PhD principal investigator
Vrij University (VU) Medical Center
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 Early Stage Osteoarthritis of the CMC-1 Joint, run by Articulinx at 1 site in Netherlands.
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 10 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: status not confirmed, as of the sponsor's last update on 22 Oct 2013. 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 Netherlands. 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?
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?
The primary endpoint of this study is the Incidence of unanticipated device and procedure related adverse events. (time frame: Intra-operatively and through one year follow-up.). 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 22 Oct 2013.