Needle Arthroscopy vs Conventional Arthroscopy in Knees

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPanam Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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.

Disqualifiers

• 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Needle Arthroscopy

    Procedure/Surgery

    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.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: NanoScope Needle ArthroscopyExperimental treatment 1 intervention
Group B: Conventional ArthroscopyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Postoperative Pain

measured using VAS and opioid use

Time frame
14 days

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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