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Osteoarthritis of the CMC-1 JointNCT01973803

Clinical Evaluation of the Articulinx InterCarpoMetacarpal Cushion (ICMC) for Osteoarthritis of the First Metacarpal Joint

An observational study of Osteoarthritis of the CMC-1 Joint, run by Articulinx at 3 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
Osteoarthritis of the CMC-1 Joint
How many people
40 participants
Where
3 sitesGermany
Study dates
Sep 2013to Dec 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 osteoarthritis who may seek treatment at physician hand clinics and community general practitioner clinics.

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
  • 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
  • Patient has concomitant musculoskeletal pathology of the target hand, such as carpal tunnel syndrome, palmar tenosynovitis, schaphoulnate 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)
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  • 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; prior surgery within the previous 12 months on the wrist of the target hand that could alter the biomechanics of the wrist or CMC-1 joint or; prior surgery on the wrist of the target hand more than 12 months previously fro which there are existing sequelae
  • 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, Ehler-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
  • 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

3 sites in 1 country.

Germany3 sites

  • Stiftungsklinikum Mittelrhein

    Koblenz, 56068

  • Berufsgenossenschaftliche (B-G) Unfallklinik Tübingen

    Tübingen, 72076

  • University of Wurzburg, Klinik und Poliklinik für Unfall-, Hand-, Plastische und Wiederherstellungschirurgie

    Würzburg, 97080

Other trials in Germany

About this study

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 40 subjects. Each subject will be compared to their pre-surgery status for each endpoint.

Read the detailed description

The Articulinx ICMC is 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 primary objective is to document the performance of the Articulinx ICMC by evaluating pain relief in the CMC joint following device implantation. CMC-1 joint function will be assessed by measurement of lateral key and tripod pinch strength, grip strength, and range of motion. Patient reported physical functioning and symptoms will be measured by DASH scores. Trapezial height will be measured on standard PA xrays of the CMC joint. Incidence of unanticipated device and procedure related adverse events will be documented intraoperatively through one year follow-up.

Primary and secondary outcomes will be evaluated through one year and subjects will continue to be followed for two years for evaluation of longer term performance.

Keywords
Carpometacarpal joint, Osteoarthritis of CMC-1 joint

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average CMC joint pain score

    The post-operative VAS pain score will be compared to pre-operative baseline VAS pain score at one year.

    Measured: One year

Secondary outcomes (4)

  1. Change in joint function

    Change in joint function post-procedure compared to pre-operative baseline. Measurements of contralateral hand function will be taken at baseline and at subsequent follow-up visits through one year.

    Measured: One year

  2. Change in DASH scores

    Change in DASH scores post-procedure as compared to pre-operative baseline

    Measured: One year

  3. Maintenance of trapezial joint space height

    Maintenance of trapezial joint space height compared to pre-operative baseline.

    Measured: One year

  4. Incidence of unanticipated device and procedure related adverse events

    Incidence of unanticipated device and procedure related adverse events intraoperatively and through one year follow-up.

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2014 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01973803
Sponsor's protocol ID
CL 0030
Status last verified
Oct 2013
First submitted
25 Oct 2013
Last updated
1 Nov 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis of the CMC-1 Joint, run by Articulinx at 3 sites in Germany.

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 8 inclusion and 20 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 1 Nov 2013. 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 Germany. 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?

Average CMC joint pain score (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01973803.

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 1 Nov 2013.

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