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NCT07823504

Needle Arthroscopy vs Conventional Arthroscopy in Knees

Sponsor: Panam Clinic

View on ClinicalTrials.gov

Summary

This is a pilot randomized controlled trial will have 54 participants. The purpose of this study is to compare two surgical techniques to determine the differences in postoperative pain and early recovery in patients between 18-65 years old with simple knee pathologies including meniscal tear, chondral lesions, and loose bodies. Patient-reported outcomes and operative efficiency will be also compared. The two surgical techniques we are comparing are: 1. NanoScope™ Needle Arthroscopy for the affected knee 2. Conventional Arthroscopy for the affected knee Patients will be randomized pre-operatively but final eligibility will be confirmed intra-operatively. The study assessors and data analysts will be blinded to the treatment group via limited access to surgical records and post-operative imaging. If patients consent to participate they will be asked to come to research visits at baseline (pre-operatively), at 2-weeks, 6-weeks, and 3-month post-operatively to complete a set of questionnaires including a demographic form, SANE score, IKDC Subjective, and the EQ-5D VAS Pain, Pain and Medication Logbook will be completed from the day of surgery until day 14, and a Rehabilitation Log will assess "Return to Activity/Work". A clinical assessment will include: Range of motion, effusion, and joint line tenderness. A pre-operative X-ray and MRI will be collected as standard of care. Patients will be remunerated with a maximum of $160 if they come to all research visits.

Official title: A Randomized Controlled Trial Comparing NanoScope Needle Arthroscopy Versus Conventional Arthroscopy for the Treatment of Simple Knee Pathology

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2027-01

Completion Date

2028-12

Last Updated

2026-09-16

Healthy Volunteers

Conditions

Meniscectomy Meniscal Tears Meniscal Repair Chondral Lesion of the Knee Loose Body Knee

Interventions

PROCEDURE

Needle Arthroscopy

Needle Arthroscopy: Local Anesthesia (1% Lidocaine with Epinephrine) at portal sites + intra-articular injection. IV Sedation or Light General Anesthesia (LMA) may be utilized based on patient anxiety and surgeon preference. A tourniquet will be applied but not inflated unless visualization is compromised by bleeding. This procedure uses very small openings in the knee made with specialized needles and a tiny 1.9mm camera system called the NanoScope™. The surgeon first examines the knee and then performs the needed treatment (e.g. meniscectomy) using small surgical instruments designed for this system. The small openings are usually closed with adhesive strips or, if needed, a single suture.

Inclusion Criteria: * • Clinical diagnosis of: Meniscal tears (Medial or Lateral) suitable for partial meniscectomy or simple repair; Chondral lesions / Chondromalacia (ICRS Grade 1-3); Loose bodies; Synovitis requiring synovectomy; Cyclops lesion (post-ACL reconstruction). * Age: 18 to 65 years at time of surgery. * Imaging: Pre-operative MRI performed within 6 months of the surgery date. And an X-ray showing no fractures. * Consent: Willingness and ability to provide informed consent and attend follow-up visits. Exclusion Criteria: * • Instability: Concomitant ACL, PCL, or multi-ligament injury requiring reconstruction (reconstruction cannot be performed solely with NanoScope). * Osteoarthritis: Advanced Osteoarthritis defined as Kellgren-Lawrence Grade 3 or 4 (bone-on-bone) on pre-operative weight-bearing radiographs. * Complex Pathology: Complex meniscal tears requiring repair techniques strictly requiring standard instrumentation (e.g., large bucket-handle tears requiring inside-out/outside-in sutures). * Infection: Active local or systemic infection. * BMI: Body Mass Index \> 40 (due to potential visualization difficulties with the 1.9mm system in deep soft tissue). * Previous Surgery: Revision meniscal repair on the affected compartment (unless simple debridement). * Legal/WCB: Patients involved in active litigation or Workers Compensation Board (WCB) claims. * Language: Unable to speak, read, or understand English (preventing completion of PROMs). * Pregnancy: at the time of surgery. * Mental Health: Conditions that preclude informed consent and follow-up (e.g. mental capacity, impaired judgment and/or memory, severe mood episodes, dementia, etc). * Major illness: Life expectancy \<1yr or unacceptably high surgery risk). Intra-operative exclusions: Final assessment of eligibility will be made intra-operatively and include: * Arthritis: If grade 3 or 4 chondral damage (exposed bone) is discovered intra-operatively that was not evident on radiographs, the patient may be excluded from the per-protocol analysis but retained for safety analysis. * Technique Failure (Crossover): If a patient randomized to the NanoScope Group has pathology that cannot be adequately visualized or treated with the needle system (e.g., tight compartment, excessive bleeding, or inability to access pathology), the surgeon will convert to Conventional Arthroscopy. These patients will be considered "enrolled" and analyzed in their original randomized group (Intention-to-Treat principle), but the case will be documented as a "Failure of Technique".