Knee Osteoarthritis, Total Knee Arthroplasty
Conditions
Keywords
Total knee arthroplasty, Prehabilitation, Osteoarthritis phenotype, Rehabilitation, Electromyography
Brief summary
Total knee arthroplasty (TKA) is the most effective treatment for stage III-IV knee osteoarthritis (OA). However, up to 30% of patients remain dissatisfied due to periarticular functional insufficiency, pain, and movement limitations. This study aims to improve TKA outcomes by developing and implementing a multimodal prehabilitation approach based on OA phenotypes (chronic pain, inflammatory, biomechanical) to correct clinical and functional disorders preoperatively, thereby enhancing postoperative recovery and quality of life.
Detailed description
Objectives: 1. To develop and implement a multimodal prehabilitation approach for patients undergoing TKA. 2. To create a computer program for selecting an individual prehabilitation complex based on the identified OA phenotype. 3. To compare TKA outcomes in patients with and without the prehabilitation complex. 4. To evaluate the effectiveness of the prehabilitation approach using a dedicated computer program. 5. To improve the algorithm of medical care organization for patients undergoing TKA. Study Material: A total of 64 patients with knee OA stage III-IV (Kellgren-Lawrence classification) were included. Patients were randomized into two groups: the main group (n=31) receiving the prehabilitation complex, and the control group (n=33) receiving standard preoperative care. Study Design: Single-center, prospective, open-label, randomized, controlled interventional clinical study. Inclusion Criteria: * Age 18 to 70 years * Verified knee OA stage III-IV (Kellgren-Lawrence) * Intermalleolar distance ≤ 8 cm (valgus) or intercondylar distance ≤ 8 cm (varus) * Limb shortening ≤ 2 cm * BMI \< 35 kg/m² * Barthel Index \> 65 points * No decompensation of concomitant chronic diseases * No recent physiotherapy or intra-articular injections (within 1-3 months) * Signed informed consent Exclusion Criteria: * Age \< 18 or \> 70 years * Limb shortening \> 2 cm * Previous knee surgery or trauma indicating secondary OA * BMI ≥ 35 kg/m² * Decompensated chronic infectious or non-infectious diseases * Inability to comply with the follow-up schedule Methods: Clinical and functional assessment was performed 4 weeks and 72 hours before surgery, and 72 hours, 4 weeks, and 12 weeks after surgery. Assessment tools included WOMAC, KOOS, VAS, HSS-KRES questionnaires, surface electromyography (EMG) of thigh and calf muscles, Two Minute Walking Test (2MWT), and Timed Up and Go (TUG) test. Statistical analysis was performed using IBM SPSS Statistics 25. Scientific Novelty: A new multimodal prehabilitation approach based on OA phenotyping was developed and patented (RF Patent No. 2844621). Two computer programs were created: one for determining the individual prehabilitation complex (RF Software Certificate No. 2026610177) and another for evaluating prehabilitation results (RF Software Certificate No. 2025662976). Expected Results: The prehabilitation complex is expected to increase the rate of favorable clinical outcomes by 2.13 times at 12 weeks post-TKA, with significant improvements in WOMAC, VAS, EMG parameters, and 2MWT distance compared to the control group.
Interventions
PROCEDUREMultimodal phenotype-based prehabilitation
A 4-week preoperative program including active/passive mechanotherapy, breathing exercises, psychological support, and phenotype-specific interventions (SMT for chronic pain, magnetotherapy for inflammation, robotic mechanotherapy for biomechanical restrictions) combined with kinesiotaping, aimed at correcting clinical and functional disorders before TKA.
Sponsors
Samara State Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking is not possible due to the nature of the prehabilitation and surgical procedures; both the operator and the patient are aware of the group assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 70 years * Verified knee OA stage III-IV (Kellgren-Lawrence) * Intermalleolar distance ≤ 8 cm (valgus) or intercondylar distance ≤ 8 cm (varus) * Limb shortening ≤ 2 cm * BMI \< 35 kg/m² * Barthel Index \> 65 points * No decompensation of concomitant chronic diseases * No recent physiotherapy or intra-articular injections (within 1-3 months) * Signed informed consent
Exclusion criteria
* Age \< 18 or \> 70 years * Limb shortening \> 2 cm * Previous knee surgery or trauma indicating secondary OA * BMI ≥ 35 kg/m² * Decompensated chronic infectious or non-infectious diseases * Inability to comply with the follow-up schedule
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC score change | Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op | Assessment of osteoarthritis severity and functional status using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Lower scores indicate better outcomes. |
| VAS pain score change | Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op | Assessment of pain intensity using the Visual Analogue Scale (VAS), score 0-10. Lower scores indicate less pain. |
| m. rectus femoris action potential amplitude | Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op | Assessment of neuromuscular control and muscle activity using surface electromyography (EMG), measured in mkV. |
| Two Minute Walking Test (2MWT) distance | Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op | Assessment of functional mobility and endurance, measured in meters covered in 2 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KOOS score change | Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op | Assessment of knee injury and osteoarthritis outcome across multiple domains (symptoms, pain, ADL, sport/recreation, quality of life). |
| Timed Up and Go (TUG) test time | Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op | Assessment of dynamic balance and functional mobility, measured in seconds. |
Countries
Russia
Contacts
PRINCIPAL_INVESTIGATORDmitry Sergeevich Kudashhev, MD, PhD, Associate Professor
Samara State Medical University
Outcome results
None listed