Clinical trial NCT06835621: Comparison of Functional Recovery Between Restricted Inverse Kinematic Alignment and Adjusted Mechanical Alignment With Robotic-assisted Unilateral Total Knee Arthroplasty.
Official title: Comparison of Functional Recovery Between Restricted Inverse Kinematic Alignment and Adjusted Mechanical Alignment With Robotic-assisted Unilateral Total Knee Arthroplasty. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: OA Knee
TKA
Keywords: Osteoarthritis (OA) of the Knee
OA knee
MAKO
Kinematic alignment
Mechanical alignment
Restricted Kinematic alignment
Inversed Kinematic alignment
Inversed Restricted Kinematic alignment
Robotic assist Total Knee Arthroplasty
Adjusted mechanical alignment
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if restricted inverse kinematic alignment total knee arthroplasty (restricted iKA TKA) improves functional recovery compared to adjusted mechanical alignment total knee arthroplasty (aMA TKA) in patients undergoing unilateral robotic-assisted total knee arthroplasty by comparing performance-based outcome, 2-minute walk test (2MWT) as a primary outcome. This trial will also assess other outcomes including satisfaction, patient-reported functional outcomes, range of motion, visual analog scale for pain and complication of both techniques. The main question aims to answer is:

In unilateral robotic-assisted total knee arthroplasty, dose Restricted iKA technique provide better postoperative performance-based outcome compared to aMA technique?

Researchers will compare restricted iKA and aMA technique to determine which technique offers better acceleration in functional recovery and patient satisfaction.

Participants will:

After randomization, participants will allocate to either restricted iKA or aMA technique for unilateral robotic-assisted total knee arthroplasty.

Attend follow-up visits for assessments of 2-minute walk test (Primary outcome), Time up and go test (TUG), VAS for pain, ROM and complete patient-reported functional outcome questionnaires regarding knee function and satisfaction at regular intervals.

Detailed description: Nowadays, total knee arthroplasty (TKA) for the treatment of osteoarthritis patients generally aims to achieve a neutral alignment of the leg. This involves cutting the bones perpendicular to the mechanical axis in both the femur and tibia. This method is called mechanical alignment TKA (MA TKA), which is widely popular and is often considered the standard technique for TKA. It has shown satisfactory long-term outcomes. However, despite advancements in materials and surgical techniques, MA TKA still requires bone and soft tissue adjustments to correct alignment, which may involve releasing soft tissues. This can result in post-surgical pain or dissatisfaction, with up to 20% of patients reporting dissatisfaction despite improved knee pain compared to pre-surgery. Furthermore, 1 in 4 of these dissatisfied patients do not wish to undergo a revision surgery, as the MA TKA method is a "one-size-fits-all" approach that aims to achieve equal and parallel gaps between the femur and tibia components without respecting individual soft tissue balance and the original alignment of each patient's leg. However, adjusted mechanical alignment technique, an adaptation of conventional MA technique with under-correction of constitutional coronal deformity, within a limit of ± 3° (HKA -3° to 3) has been introduced according to the constitutional deformity and coronal plan alignment of the knee concept.

In 2006, Howell introduced kinematic alignment TKA (KA TKA) as an alternative, with the goal of restoring the patient's natural kinematic axis and reducing the incidence of pain related to TKA rather than focusing on equal medial and lateral joint line gap and neutral mechanical axis like in mechanical alignment technique. KA TKA is considered a more personalized approach because it aims to replicate the knee's pre-arthritic alignment and movement, believing that each patient's knee has a unique alignment. This approach has gained increasing interest in recent years, with studies reporting good short- to mid-term clinical outcomes. However, the KA technique is more complex because we cannot always know the pre-arthritic alignment of individual patients and measuring soft tissue tension remains imprecise.

Later, Dr. Pascal-André Vendittoli proposed the restricted kinematic alignment TKA (rKA TKA) technique to restore natural knee movement while avoiding excessive correction of coronal alignment by maintain the HKA axis within ± 3 degrees (safe zone). By maintaining some of the constitutional deformity, this technique reduces the need for excessive soft tissue or ligament releases. In 2020 Winnock et al, introduced the Inversed kinematic technique (iKA) or tibia-referenced technique by resurfacing the tibia with equal medial and lateral resections maintaining the native tibial joint line obliquity before distal femoral bone. When combines these KA principles with robotic-assisted TKA, enhancing the accuracy of soft tissue balancing and the overall effectiveness of the procedure.

In 2020, McEwen et al. compared the use of robotic-assisted KA with MA in the same patients who underwent bilateral knee surgery using different techniques. They found that clinical outcomes, including range of motion and knee scores, were not significantly different at any time point. However, Elbuluk conducted a similar comparison, specifically robotic-assisted (MAKO) KA versus MA, and found that the KA group had less pain and better knee scores, including a higher Forgotten Joint Score. Later, Abhari conducted a study comparing robotic-assisted (MAKO) restricted KA with non-robotic MA TKA and found that the robotic-assisted (MAKO) restricted KA group had superior clinical outcomes and knee scores, including the Forgotten Joint Score, KOOS, WOMAC, Knee Society Score, as well as greater patient satisfaction. However, there are still limited prospective RCTs that study differences in outcomes, especially performance-based outcomes between restricted inverse kinematic alignment (restricted iKA) versus adjusted mechanical alignment (aMA). Therefore, the researchers aim to conduct a study comparing the efficiency of performance-based outcomes as a primary focus, including patient-reported outcome questionnaires, ROM, VAS for postoperative pain, postoperative morphine consumption within 24 hours, postoperative lower limb alignment (HKA axis), operative time, blood loss, and complications. The goal is to further advance the development of knee replacement surgery.

Eligibility criteria: Inclusion Criteria:

* Age 50 - 80 years old
* Diagnosed with primary OA knee and indicated for unilateral total knee arthroplasty with MAKO robotic-assisted knee replacement system
* ASA classification I-II

Exclusion Criteria:

* Valgus deformity
* KL grading \> 3 on contralateral knee
* Unable or difficulty for walking due to comorbidities
* BMI \> 40 kg/m2
* Previous knee surgery
* Infection around the knee

Primary outcomes:
measure: 2-minute walk test
timeFrame: From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)
Secondary outcomes:
measure: Time up and go test
timeFrame: From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)
measure: modified WOMAC scale for knee pain (Thai version)
timeFrame: From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)
measure: Thai version of the Forgotten Joint Score
timeFrame: From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)
measure: Oxford knee score
timeFrame: From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)
measure: Range of Motion
timeFrame: From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)
measure: Hip knee ankle angle
timeFrame: From enrollment (preoperative measurement) and at 1-year postoperative follow-up.
measure: Visual analog scale for Pain
timeFrame: From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)
measure: Morphine consumption
timeFrame: Postoperative interval of 24-72 hours
measure: Complication
timeFrame: After surgery and up to 2 years
measure: Medial proximal tibial angle (MPTA)
timeFrame: From enrollment (preoperative measurement) and at 1-year postoperative follow-up.
measure: Lateral distal femoral angle (LDFA)
timeFrame: From enrollment (preoperative measurement) and at 1-year postoperative follow-up.
measure: Joint line obliquity (JLO)
timeFrame: From enrollment (preoperative measurement) and at 1-year postoperative follow-up.
Other outcomes:
Locations:
city: Klongluang
country: Thailand
facility: Faculty of Medicine, Thammasat University
state: Pathum-Thani
city: Klongluang
country: Thailand
facility: Faculty of Medicine, Thammasat University
state: Pathum-Thani
Study officials:
References:
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