A Randomized Controlled Trial Comparing NanoScope Needle Arthroscopy Versus Conventional Arthroscopy for the Treatment of Simple Knee Pathology
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 主要终点
- Postoperative Pain
研究概览
简要总结
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:
- NanoScope™ Needle Arthroscopy for the affected knee
- 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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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.
排除标准
- •• 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".
研究组 & 干预措施
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.
干预措施: Needle Arthroscopy (Procedure)
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. This is the current standard of care for the included pathologies.
结局指标
主要结局
Postoperative Pain
时间窗: 14 days
measured using VAS and opioid use
次要结局
未报告次要终点
研究者
Peter MacDonald
Orthopaedic Surgeon
Panam Clinic