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NCT Number: NCT06603740

Nanoscope Cost Analysis Study

The study is a pilot study designed to generate preliminary data regarding the cost of partial meniscectomy using NanoScope versus conventional arthroscopy in a traditional operating room (OR) setting

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopedic Rhode Island

Warwick, Rhode Island, 02886, United States

Location contact

Jennifer Stedman

CONTACT

401-777-7000

Michael Bradley, MD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject requires simple partial posterior or mid-body meniscectomy.
  • Subject is 18 - 60 years of age.
  • Subject body mass index (BMI) is 35 or lower (BMI ≤ 35).
  • Subject signed informed consent and is willing and able to comply with all study requirements and follow-up visits.
  • Confirmed meniscal injury by physical exam as per standard of care.
  • Normal mechanical alignment; < 5° varus and < 7° valgus, of the affected knee by clinical assessment or X-Rays as per standard of care

Exclusion criteria

  • Subject requires complex repair or anterior meniscectomy.
  • Subject has a concomitant chondral lesion of the ipsilateral knee in addition to meniscal tear.
  • Current bilateral knee injury.
  • Insufficient quantity or quality of bone.
  • Blood supply limitations and previous infections which may retard healing.
  • Congenital ligamentous hypermobility defined by Beighton score 4 or 5.
  • Locked knee or haemarthrosis.
  • Subjects that are skeletally immature.
  • Advanced Osteoarthritis; Kellgren Lawrence ≥ 2
  • Fracture of the lower extremities within 6 months prior to screening.
  • Previous surgery on the affected knee within 12 months prior to screening.
  • Sensitivity to silicone, polyester, nylon, FD&C Blue No. 2 dye and beeswax.
  • Other concomitant disease that would interfere with study outcomes.
  • Subject is included in a vulnerable population (child, prisoner, etc).
  • Conditions that tend to limit the patient's ability or willingness to restrict activities, follow directions, or perform online subject assessments during the healing period.
  • Subject is requesting or receiving Worker's compensation related to the knee injury. -

Treatment and study plan

Arthrex Nanoscope

Device

Arthrex's all-in-one disposable, 2 mm, chip-on-tip camera system now allows surgeons to miniaturize their treatment solutions

Conventional Arthroscopy without Arthrex Nanoscope

Device

partial meniscectomy using conventional arthroscopy

Primary outcomes

  1. Cost Comparison (TDBC)

    Time frame: Operative Visit

    Cost comparison using the time-drive activity-based costing (TDABC) study design between NanoScope versus conventional arthroscopy for partial meniscectomy in a traditional OR setting.

Secondary outcomes

  1. International Knee Documentation Committee (IKDC) Score

    Time frame: Pre Operative, 2 weeks and 6 weeks post op

    The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee.

    The questions prompt an answer 0-10.

    The total score is interpreted as a measure of function with higher scores representing higher levels of function.

  2. Visual Analogue Scale (VAS)

    Time frame: Pre Operative, 2 weeks and 6 weeks post op

    The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.v

Other outcomes

  1. Knee Injury and Osteoarthritis outcome Score (KOOS)

    Time frame: Pre Operative, 2 weeks and 6 weeks post op

    KOOS is a five-subscale patient-reported instrument intended for use from the time of knee injury to the development of osteoarthritis.

    Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures

  2. PROMIS Pain Interference 6a scale

    Time frame: preop, 2 weeks post op, and 6 weeks post op

  3. PROMIS Pain Intensity 3a scale

    Time frame: preop, 2 weeks post op, and 6 weeks post op

  4. PROMIS Physical Function 13a scale

    Time frame: preop, 2 weeks post op, and 6 weeks post op

Study contacts

Contact information is provided by the study sponsor or research team.

Carolie I Caraci, BA

CONTACT

[email protected]

18009337001

Sponsors and collaborators

Lead sponsor

Arthrex, Inc.

Industry

Registry information

Official study title

Randomized Study Evaluating Cost of Arthrex Nano Arthroscopy Products in Arthroscopic Knee Meniscectomy Versus Conventional Arthroscopy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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