NCT07823504

Brief 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. 1.NanoScope™ Needle Arthroscopy for the affected knee
  2. 2.Conventional Arthroscopy for the affected knee Patients will be randomized pre-operatively but final eligibility will be confirmed intra-operatively.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
23mo left

Started Jan 2027

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

1.2 years

First QC Date

September 11, 2026

Last Update Submit

September 11, 2026

Conditions

Keywords

simple knee pathologyarthroscopy

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

    measured using VAS and opioid use

    14 days

Study Arms (2)

NanoScope Needle Arthroscopy

EXPERIMENTAL

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.

Procedure: Needle Arthroscopy

Conventional Arthroscopy

NO INTERVENTION

General Anesthesia (LMA/ET) or Spinal Anesthesia will be utilized. A tight tourniquet is applied and inflated prior to incision as standard of care. This standard procedure uses two small openings in the knee, each about 4-5mm wide. The surgeon examines the knee and performs the required treatment using a 4.0mm standard-sized camera and surgical instruments (shavers, biters). The openings are closed with nylon sutures or adhesive strips. This is the current standard of care for the included pathologies.

Interventions

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.

NanoScope Needle Arthroscopy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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".

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 16, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

September 16, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share