Needle Arthroscopy vs Conventional Arthroscopy in Knees

The purpose of this pilot study is to compare two techniques- (1) NanoScope™ Needle Arthroscopy for the affected knee (2) Conventional Arthroscopy for the affected knee - in patients undergoing a simple knee pathology such as meniscal tear, loose bodies, and chondral lesions.

The primary research question is: "In patients undergoing knee arthroscopy for simple pathology, is there a difference in postoperative pain (VAS) and early recovery between NanoScope™ needle arthroscopy and Conventional arthroscopy?"

The primary objective: to compare patient-reported pain scores (VAS) and opioid consumption between the two study groups in the immediate postoperative period (14 days).

The secondary objectives:

• To compare functional recovery and Range of Motion (ROM) at 2 weeks, 6 weeks and 3 months postoperative.
• To compare time to Return to Activity (work and sport) between groups.
• To compare diagnostic accuracy (concordance with MRI) and operative efficiency (surgical time, turnover time).

The tertiary objective: to evaluate healthcare resource use and direct costs for NanoScope arthroscopy compared to Conventional arthroscopy in the operating room setting.

Design: This is a pilot, prospective, single-centre, randomized clinical trial comparing two groups to determine the differences in postoperative pain and early recovery: 1) NanoScope™ needle arthroscopy and 2) Conventional arthroscopy. All participants will have been diagnosed with simple intra-articular knee pathology (e.g. meniscal tear, chondral lesion, loose body) amenable to arthroscopic treatment. A total of 54 participants with 27 participants per study group will be randomized at a 1:1 ratio to the two arms, blocking within surgeon with random block sizes to prevent group imbalances.

In this study, the study assessors and data analysts will be blinded to the treatment group via limited access to surgical records and post-operative imaging. Patients will be asked to wear a knee sleeve at every research visit for blinding purposes to ensure study assessors remain blinded. The knee sleeve will be provided to the participants at the start of every research visit-clinic appointments with patient's surgeon are held separately so NO knee sleeve will be utilized on the patient since surgeon is not blinded. Given the nature of the surgical procedures and the surgical openings (portals) size differences, the patient can not be kept fully blind for the entire duration of the study. So, for them to maintain blinded, the surgical staff will apply an absorbent bulky dressing and bandages on their knee right after surgery. Patients will be instructed NOT to remove these until their first follow-up visit with their surgeon (Day)14.

Inclusion Criteria:

Patients must meet ALL of the following criteria to be considered eligible:

1. Confirmed diagnosis of SIMPLE intra-articular knee pathology (medial or lateral meniscal tears suitable for partial meniscectomy or simple repair, chondral lesion, or loose body amenable to arthroscopic treatment.
2. 18 to </= 65 years of age (at time of surgery).
3. X-ray showing: no fractures.
4. MRI 6 months prior to surgery. 6) Willingness and ability to be followed for 3 months post-operatively and provide informed consent.

Exclusion Criteria:

Patients are excluded if ANY of the following exclusion criteria are met:

1. Instability: Concomitant ACL, PCL, or multi-ligament injury requiring reconstruction.
2. Advanced osteoarthritis (Grade 3-4 chondral damage) bone-on-bone.
3. Complex pathology: Meniscal tears requiring repair techniques strictly requiring standard instrumentation.
4. Infection: Active local or systemic infection.
5. Body Mass Index > 40 (due to potential visualization difficulties with the 1.9mm system in deep soft tissue).
6. Previous surgery: Revision meniscal repair on the affected compartment (unless simple debridement).
7. Workers Compensation Board (WCB) or Litigation Claim.
8. Pregnancy (at the time of surgery).
9. Mental health conditions that preclude informed consent and follow-up (e.g. mental capacity, impaired judgment and/or memory, severe mood episodes, dementia, etc).
10. Unable to speak, read or understand the English language.
11. Major medical illness (life expectancy <1yr or unacceptably high surgery risk).

Intra-operative exclusions:

1. 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.

Study procedures:

1. NanoScope™ 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. If the surgeon cannot see or reach the area well enough, the procedure will be changed to a standard arthroscopy and the patient 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".
2. Conventional Arthroscopy: 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.

Regardless of study group allocation, a standardized bulky absorbent dressing and tensor bandage will be applied to the knee to mask the difference in portal (opening) size once the surgery has been completed.

Randomization:

Patients will be randomized pre-operatively via the EmPOWER database which will allocate a random study ID for tracking and analysis. Randomization will occur prior to anesthesia induction and surgery positioning to one of two study groups. Group assignment is based on the type of surgical procedure being done to stabilize the knee. The two study groups are:

(1) NanoScope™ Needle Arthroscopy

(1) NanoScope™ Needle Arthroscopy

This timing is required to allow the nursing staff to set up the appropriate arthroscopy tower (NanoScope™ system vs Conventional tower) and sterile equipment pack, which differ significantly between groups.

Final eligibility will be confirmed via examination under anesthesia and documented on the final eligibility form. Any patient who does not meet the intra-operative criteria will be deemed 'ineligible' and treated as per the surgeon's discretion-patients will be informed about the surgeon decision after their surgery and will be contacted by the research coordinator to explain the reason behind them being ineligible for the study criteria. Demographic and baseline data for patients excluded intra-operatively will be reported as well as the reason for exclusion.

As mentioned above, 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 study.

After Surgery Procedures:

Patients will be instructed not to remove the bulky dressing and tensor bandages that will be applied immediately after surgery by the operating staff until their first wound check visit (Day 14) with their surgeon. Therefore, patient will remain blinded to their study group assignment while completing the daily Pain and Medication Logbook that needs to be completed from Day 0-14 since their surgery day. Since portals (openings) are from different sizes this process is crucial to keep patient blinded while completing the pain and medication logbook.

Upon discharge, patients will be provided with a set of standard of care instructions related to wound care, rehabilitation, and follow-up appointments. Patients are instructed NOT to remove the bulky dressing until their first follow-up visit (Day 14) to maintain blinding during the primary pain assessment period. The research staff will distribute and provide instructions for the Pain and Medication Logbook, once discharged patients will be responsible for documenting pain levels and medication for 14 days after their surgery. Prescription orders will not be standardized because some patients cannot tolerate certain medications.

Rehabilitation Protocol: Postoperative rehabilitation will be standardized for all patients regardless of study knee and will be provided to patients in a document outlining post-operative instructions at each stage of recovery. Generally, this protocol will consist of tissue protection, motor control, and functional optimization.

Imaging: Radiographs in this study are standard of care, an X-ray and MRI will be taken pre-operatively. X-ray of the affected knee will be obtained including weight bearing Antero-Posterior (AP), Lateral, Skyline (Merchant), and Rosenberg (PA flexion). To detect occult joint space narrowing in the notch, and to assess any development of osteoarthritis. Imaging will be performed any time before surgery. All MRI's in this study are standard of care and are used to determine eligibility at baseline.

Study Visits:

Patients will be assessed pre-operatively and then at 2-weeks (+/- 7 days), 6-weeks (+/- 2 weeks), and 3 months (+/- 2 weeks) post-operatively. This post-operative follow-up schedule does not incur added costs or visits to the patients as it is in keeping with the current practice at the trial centres and all visits fall under the standard of care follow-ups. If patients are unable to attend their planned follow-up as per the established schedule, they will be contacted by telephone, email, or paper mail, and may be asked to complete their questionnaires. Patient outcome measures include: SANE score, IKDC subjective, EQ-5D VAS pain, a pain and medication log, and a rehabilitation log to assess "Return to Activity/Work. A clinical exam including knee ROM, effusion, and joint line tenderness will also be conducted by the study assessors- adverse events and complications, and study completion/duration will be completed to document the reason and date when patient's participation in the study ends (i.e. finished the course of the study, withdrew, etc.).

All participants will be registered in Empower Health Research database (a secure study management software system), which assigns a unique identifier called a database ID number to each patient. This information will be used for analyses by the principal investigator of this study and their research staff. No personal information (i.e., name, address, telephone number, personal health records number) will be entered into this database.

Patients will be remunerated for every research visit they attend for a maximum of up to $160, the compensation schedule will be as follows:

• Informed Consent \& Baseline Visit- $40
• 2-week follow-up visit: $40
• 6-week follow-up visit: $40
• 3-month follow-up visit: $40

Patients are free to withdraw at any time for any reason.