Knee Osteoarthritis
Conditions
Keywords
Total knee arthroplasty, Unicompartmental knee arthroplasty, Robot-assisted surgery, Pilot randomized controlled trial, Bicompartmental knee arthroplasty, Mako partial knee
Brief summary
This is a pilot randomized trial to assess the feasibility of a definitive trial to determine the effect of robot-assisted partial knee replacements versus standard total knee replacements.
Detailed description
Knee osteoarthritis (OA) pain is an important source of morbidity and cost to the health care system. Over 60,000 knee replacement surgeries are performed in Canada every year, making it the second most common surgery. Our institution (St. Joseph's Healthcare Hamilton) is the first hospital in Canada to purchase a Mako RIO orthopaedic robot to assist with performing knee replacements. The knee is divided into three compartments, and one, two, or all three compartments can become arthritic. Over 90% of patients with end-stage knee OA receive a total knee replacement (also known as total knee arthroplasty or TKA) even if they have one or two healthy knee compartments. Partial knee replacements are an option for these patients but these procedures are very technically demanding and associated with a higher risk of implant failure. For this reason, few surgeons are experts at partial knee replacements. We believe that we can use robotic technology to make it easier for surgeons to perform partial replacements more accurately, thereby increasing the quality and survivorship of partial knee replacements. This may lead to better patient-important outcomes like return to activity, pain, and satisfaction, and eventually better access to high-quality partial knee replacements for Canadians. This will be the first study to evaluate total knee replacements (standard care) versus robot-assisted partial knee replacements, and could lead to greater uptake of robotic technology in orthopaedics and a shift toward anatomy-sparing partial knee replacements.
Interventions
PROCEDURETotal knee arthroplasty
Surgeon will perform a total knee arthroplasty procedure according to local standard of care
PROCEDURERobot-assisted partial knee arthroplasty
Surgeon will perform a robot-assisted unicompartmental or bicompartmental knee arthroplasty procedure
Sponsors
St. Joseph's Healthcare Hamilton
Hamilton Academic Health Sciences Organization
Canadian Institutes of Health Research (CIHR)
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Surgeons cannot be blinded to treatment group. It would not be feasible to blind the health care team and patients because the incisions and imaging are visually distinguishable. We will attempt to minimize bias in subjective measures by presenting patients with balanced information on each treatment group prior to the trial. All participants will receive a computed tomography (CT) scan prior to surgery to maintain blinding and to give surgeons additional information about 3 dimensional modelling for implant placement. Data analysts will be blinded to treatment allocation. An independent outcomes assessor will independently review radiographic alignment for each patient and review relatedness of adverse events and re-operations. The independent assessor cannot be blinded because imaging is visually distinguishable.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (18+) * Unicompartmental knee OA with or without concomitant patellofemoral OA, requiring surgical treatment * Two study surgeons independently agree that the patient is eligible for either treatment group
Exclusion criteria
* Inability to provide informed consent (e.g. cognitive disability, language barrier) * Revision knee surgery * Simultaneous bilateral knee surgery * Previous major knee surgery or trauma * The robot or required components are unavailable (e.g. technical difficulties, robot-specific disposables out of stock) * A CT scan cannot be obtained prior to surgery * Patient does not wish to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility- Recruitment | 12 months | The number of patients recruited during a 12 month period |
| Feasibility- Participant retention | 12 months | Number of patients completing the study |
| Feasibility- Treatment compliance | 12 months | The number of crossovers during a 12 month period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait walking mechanics analysis | 12 months post-surgery | Overground walking kinematic gait analysis will be performed in the clinic environment using a ten-camera optoelectronic motion capture system. Primary gait outcomes will include the knee joint flexion and adduction angle magnitudes and range during the stance phase of gait. Secondary gait outcomes will include stride characteristics as defined above, knee transverse rotation during stance, knee flexion during swing, hip and ankle range of motion and peak magnitudes during stance. |
| Quality of life- EQ-5D | 12 months post-surgery | We will use the Euro-Qol 5 Dimensions (EQ-5D) questionnaire, a widely used and well-validated quality of life tool, to measure participant quality of life. The EQ-5D is a comprehensive, 5-item compact health status classification and health state preference questionnaire. |
| Persistent post-surgical pain (PPSP) | 12 months post-surgery | We will use a modified version of the WHO's definition of PPSP, to include a minimum threshold of pain severity: 1. Pain that began after surgery or a tissue trauma; 2. Pain is in an area of preceding surgery or tissue trauma; 3. Pain has persisted for at least three months after surgery; and 4. The pain is not better explained by an infection, malignancy, a pre-existing pain condition or any other alternative cause. 5. ≥4 out of 10 on the numeric rating scale (NRS) from the Brief Pain Inventory (BPI-SF) for average pain over the last week. The scale ranges from 0 (no pain) to 10 (pain as bad as you can imagine) |
| Patient global impression of change score | 12 months post-surgery | We will use The Patient Global Impression of Change (PGIC) scale to assess patients' beliefs about the efficacy of treatment. The PGIC is one item and asks patients to rate the effectiveness of the treatment of interest on a 7-point ordinal scale ranging from very much improved to very much worse |
| Return to function questionnaire | 12 months post-surgery | We will use the 5-item Return To Function (RTF) questionnaire to determine when a trial participant returns to work, leisure, and activities around the home after an injury or surgery (measured as time to return to unrestricted activities). |
| Rage of motion (ROM) | 6 weeks post-surgery | We will measure knee ROM using a goniometer at in-clinic visits according to standard practice |
| Knee alignment | Post-surgery | We will measure mechanical alignment on pre-operative and post-operative weightbearing x-rays |
| Adverse events | 12 months post-surgery | We will collect all serious adverse events and surgery-related non-serious adverse events throughout the trial for safety monitoring purposes |
| Short-term implant survival | 12 months post-surgery | We will report the number of revision surgeries within the study period including cases of periprosthetic joint infection, aseptic loosening, instability, poly wear, intractable pain, periprosthetic fracture etc. |
| Healthcare resource use (for cost-effectiveness) | 12 months post-surgery | We will collect healthcare resource utilization information (e.g. hospitalization, physician visits) and information on productivity (e.g. time missed from work) to assist with health economic analyses. |
| Oxford knee score | 12 months post-surgery | We will measure knee function using the Oxford Knee Score (OKS), which is a validated and well-used 12 item questionnaire used to measure knee function when performing daily activities after total knee replacement surgery. The OKS is scored on a 0-48 scale with higher scores representing a better outcome. |
| Forgotten joint score | 12 months post-surgery | We will use the Forgotten Joint Score (FJS-Knee) to measure how natural the replaced knee feels. The FJS-Knee is a 12 item questionnaire that aims to assess both function and feeling by asking about patients' awareness of their artificial knee while doing various daily activities. The FJS is scored on a 0-100 scale with higher scores representing a better outcome. |
Countries
Canada
Outcome results
None listed