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

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ClinicalTrials.gov Identifier: NCT01973803
Recruitment Status : Unknown
Verified October 2013 by Articulinx.
Recruitment status was:  Enrolling by invitation
First Posted : November 1, 2013
Last Update Posted : November 1, 2013
Sponsor:
Information provided by (Responsible Party):
Articulinx

Brief 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. 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.

Condition or disease
Osteoarthritis of the CMC-1 Joint

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.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : September 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis




Primary Outcome Measures :
  1. Average CMC joint pain score [ Time Frame: One year ]
    The post-operative VAS pain score will be compared to pre-operative baseline VAS pain score at one year.


Secondary Outcome Measures :
  1. Change in joint function [ Time Frame: One year ]
    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.

  2. Change in DASH scores [ Time Frame: One year ]
    Change in DASH scores post‐procedure as compared to pre‐operative baseline

  3. Maintenance of trapezial joint space height [ Time Frame: One year ]
    Maintenance of trapezial joint space height compared to pre‐operative baseline.

  4. Incidence of unanticipated device and procedure related adverse events [ Time Frame: One year ]
    Incidence of unanticipated device and procedure related adverse events intraoperatively and through one year follow‐up.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
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
  • 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
  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973803


Locations
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Germany
Stiftungsklinikum Mittelrhein
Koblenz, Germany, 56068
Berufsgenossenschaftliche (B-G) Unfallklinik Tübingen
Tubingen, Germany, 72076
University of Wurzburg, Klinik und Poliklinik für Unfall-, Hand-, Plastische und Wiederherstellungschirurgie
Wurzburg, Germany, 97080
Sponsors and Collaborators
Articulinx
Investigators
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Principal Investigator: Prof. Rainer Meffert, MD University of Wurzburg, Klinik und Poliklinik für Unfall-, Hand-, Plastische und Wiederherstellungschirurgie

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Responsible Party: Articulinx
ClinicalTrials.gov Identifier: NCT01973803     History of Changes
Other Study ID Numbers: CL 0030
First Posted: November 1, 2013    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

Keywords provided by Articulinx:
Carpometacarpal joint
Osteoarthritis of CMC-1 joint

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases