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NCT Number: NCT07790146

Improvement of Total Knee Arthroplasty Effectiveness Using Preoperative Prehabilitation

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Total Knee Arthroplasty

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Samara, Samara Oblast, 443099, Russia

About this study

Objectives:

  • To develop and implement a multimodal prehabilitation approach for patients undergoing TKA.
  • To create a computer program for selecting an individual prehabilitation complex based on the identified OA phenotype.
  • To compare TKA outcomes in patients with and without the prehabilitation complex.
  • To evaluate the effectiveness of the prehabilitation approach using a dedicated computer program.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Prehabilitation complex

Primary outcomes

  1. WOMAC score change

    Time frame: 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.

  2. VAS pain score change

    Time frame: 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.

  3. m. rectus femoris action potential amplitude

    Time frame: 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.

  4. Two Minute Walking Test (2MWT) distance

    Time frame: 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 outcomes

  1. KOOS score change

    Time frame: 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).

  2. Timed Up and Go (TUG) test time

    Time frame: Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op

    Assessment of dynamic balance and functional mobility, measured in seconds.

Sponsors and collaborators

Lead sponsor

Samara State Medical University

Other

Registry information

Official study title

Improvement of Total Knee Arthroplasty Effectiveness Through Preoperative Correction of Clinical and Functional Disorders Using a Multimodal Phenotype-Based Prehabilitation Approach

Acronym: TKA-PREHAB

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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