Improvement of Total Knee Arthroplasty Effectiveness Using Preoperative Prehabilitation

NCT07790146 | Completed DMC

• 1 other identifier: TKA_PREHAB_2026
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Total Knee Arthroplasty

Keywords

Total knee arthroplasty; Prehabilitation; Osteoarthritis phenotype; Rehabilitation; Electromyography

Outcome Measures

Primary Outcomes (4)

• WOMAC score change

  Assessment of osteoarthritis severity and functional status using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Lower scores indicate better outcomes.

  Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op

• VAS pain score change

  Assessment of pain intensity using the Visual Analogue Scale (VAS), score 0-10. Lower scores indicate less pain.

  Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op

• m. rectus femoris action potential amplitude

  Assessment of neuromuscular control and muscle activity using surface electromyography (EMG), measured in mkV.

  Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op

• Two Minute Walking Test (2MWT) distance

  Assessment of functional mobility and endurance, measured in meters covered in 2 minutes.

  Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op

Secondary Outcomes (2)

• KOOS score change

  Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op

• Timed Up and Go (TUG) test time

  Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op

Study Arms (2)

Main group (prehabilitation)

EXPERIMENTAL

Patients (n=31) receiving a 4-week multimodal prehabilitation complex prior to TKA, tailored to their specific OA phenotype (chronic pain, inflammatory, or biomechanical). The complex includes mechanotherapy, breathing exercises, psychological support, kinesiotaping, and phenotype-specific physiotherapy (SMT, magnetotherapy, or robotic mechanotherapy).

Procedure: Multimodal phenotype-based prehabilitation

Control group (standard care)

NO INTERVENTION

Patients (n=33) receiving standard preoperative examination and routine care without a structured, phenotype-based prehabilitation complex prior to TKA.

Interventions

Multimodal phenotype-based prehabilitation PROCEDURE

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.

Also known as: Prehabilitation complex

Main group (prehabilitation)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samara State Medical University: lead

Study Sites (1)

Clinics of Samara State Medical University, Department of Traumatology and Orthopedics

Samara, Samara Oblast, 443099, Russia

Location

Related Links

• Kotelnikov GP, Kolsanov AV, Moseev OI, et al. Variability of preoperative rehabilitation in preparation for primary arthroplasty in patients with knee osteoarthritis. Vestnik meditsinskogo instituta "REAVIZ". 2024;14(4):29-38.
• Kotelnikov GP, Kolsanov AV, Moseev OI, et al. Application of the developed prehabilitation complex in total knee arthroplasty. Physical and Rehabilitation Medicine. 2025;7(2):50-62.
• Moseev OI, Kotelnikov GP, Kudashhev DS, et al. Prehabilitation of patients in total knee arthroplasty. XII All-Russian Priorov Forum. Moscow, 2025:167-168.
• Moseev OI, Kotelnikov GP, Kudashhev DS. Expectations, satisfaction and quality of life of patients before and after primary total knee arthroplasty. Postgraduate Readings 2025. Samara, 2025:78-80.
• Kotelnikov GP, Kolsanov AV, Kudashhev DS, Moseev OI. Analysis of the results of applying a new approach to prehabilitation of patients in total knee arthroplasty. Science and Innovations in Medicine. 2026;11(2):144-150.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Dmitry Sergeevich Kudashhev, MD, PhD, Associate Professor

  Samara State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)