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Trial Information

Summary: Meniscal Implant in Subjects Undergoing Partial Medial Meniscectomy (Reminisc) - (Study Closed)

This multi-center, randomized, feasibility clinical study is designed to evaluate the safety and performance of the SIS Meniscal Implant to regrow meniscal-like tissue in subjects undergoing partial meniscectomy due to an isolated primary tear in the posterior 50% of the medial meniscus. All subjects will be followed for at least 12 months.

The primary objective of this study is to evaluate the safety of the SIS Meniscal Implant in subjects following partial medial meniscectomy, and to evaluate the proportion of subjects with evidence of tissue regrowth.

The potential risks for subjects enrolled in the pilot study include those related to arthroscopic knee surgery and those related to the SIS Meniscal implantation procedure. Risks associated with either the SIS Meniscal implantation procedure or the partial meniscectomy procedure may include adhesion, decrease in range of motion and/or subject mobility; increased pain or discomfort, articular cartilage damage, vessel or nerve injury, effusion, or synovitis. The SIS Meniscal implantation device is primarily composed of Type 1 collagen. Currently, there are numerous collagen-based devices which are available for use in soft and hard tissue applications.

The SIS Meniscus Implant may offer the benefit of regrowing tissue to replace the defective excised meniscal tissue. Therefore, subjects randomized to receive the SIS Meniscal Implant may benefit from study participation by decreasing the risk of long-term degenerative changes associated with an empty defect following partial meniscectomy.

A series of inclusion/exclusion criteria will be used to determine subject entrance into the trial. These include criteria based upon both clinical evaluation and the initial arthroscopic procedure itself. If deemed qualified, the pre-consented subject will undergo the treatment per randomization assignment.

Partial list of Inclusion Criteria

  • Male or female 18 to 55 years of age (inclusive)
  • Preoperative clinical evaluation suggests the presence of a possible isolated primary medial meniscal tear not requiring concurrent ACL repair
  • Preoperative clinical assessment suggests normal anatomic limb alignment of ± 3°
  • Preoperative MRI (performed at the site qualified by the independent image analysis company) suggests the presence of a possible isolated primary medial meniscal tear in the posterior 50% of the meniscus
  • Arthroscopy confirms presence of one or more isolated primary non repairable medial meniscal tears
  • Confirmation in subjects randomized to receive the SIS Meniscal Implant that there is sufficient peripheral meniscus (= 2 mm) after partial meniscectomy to permit implant fixation
  • Must sign an Informed Consent form

Partial List of Exclusion Criteria
Candidates will be excluded from the study if ANY of the following apply:

  • Moderate or greater symptomatic, contralateral knee involvement assessed by a Visual Analogue Scale measurement of 30mm or greater, that would prevent normal and symmetrical ambulation post-operatively and compliance with rehabilitation requirements of crutch walking
  • Any of the following conditions:
    • active joint infections
    • primary bone disease (e.g., Paget’s disease) or disorders that may adversely affect the healing process
    • crystal deposition disease (e.g., gout or pseudo-gout)
    • systemic inflammatory joint disease (e.g., rheumatoid arthritis)
    • metastatic and/or neoplastic disease
    • infectious, highly communicable diseases (e.g., active tuberculosis or active hepatitis)
    • immuno-suppressed or immuno-compromised.
  • Any of the following conditions in the index limb or joint:
    • osteoarthritis
    • osteomyelitis, septicemia, or other infections that may spread to other areas of the body
    • associated non-healed fractures in the index limb
    • lack of pain or mechanical sensations requiring surgery in the index joint
    • recurrent patellar instability (e.g., subluxation or dislocation)
    • tear of the lateral meniscus
    • avascular necrosis (AVN)
    • unstable ACL
    • prior surgical procedure of the medial meniscus
  • Known hypersensitivity to pork or pork products
  • Allergy to animal derived products
  • Systemic steroid therapy or steroid injection in the index joint within 3 months prior to surgery
  • Any of the following procedures or surgeries on the index knee within 6 months prior to surgery:
    • HA injections
    • Patellar procedures
    • Tendon or ligament repair
    • Medial or lateral articular cartilage repair
  • ACL repair surgeries within 9 months prior to surgery
  • BMI of greater than 33
  • Previously enrolled in the study
  • Receiving workman’s compensation
  • Unable to receive closed system MRI
  • Pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
  • Life expectancy less then two years
  • Inability to implant study device at the time of surgery

Contact:

Samuel K Tabet, M.D.
Cartilage Restoration Center of New Mexico
201 Cedar SE Suite 6600
Albuquerque, NM 87106
Phone: (505) 724-4352
Email: Please direct email to Peter Crotta, Dr. Tabet's Physician Assistant.*


 
New Mexico Cartilage Restoration Center Albuquerque orthopedic specialists