Clinical trial: Clinical Evaluation of the Articulinx InterCarpoMetacarpal Cushion (ICMC)for Osteoarthritis of the First CarpoMetacarpal Joint (NCT01961570)

Eligibility criteria:
Inclusion Criteria:

          -  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:

        "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?

        Exclusion Criteria:

          -  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."

          -  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?
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Contradiction