Knee OsteoarthritisTKA-PREHABNCT07790146
Improvement of Total Knee Arthroplasty Effectiveness Using Preoperative Prehabilitation
A study testing Multimodal phenotype-based prehabilitation in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Samara State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Arthroplasty
- What is being tested?
- Multimodal phenotype-based prehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- No decompensation of concomitant chronic diseases
- No recent physiotherapy or intra-articular injections (within 1-3 months)
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Clinics of Samara State Medical University, Department of Traumatology and Orthopedics
Samara, Samara Oblast, 443099
About this study
Official title: Improvement of Total Knee Arthroplasty Effectiveness Through Preoperative Correction of Clinical and Functional Disorders Using a Multimodal Phenotype-Based Prehabilitation Approach
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.
Read the detailed description
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.
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty
- Being tested
- Multimodal phenotype-based prehabilitation
- Keywords
- Total knee arthroplasty, Prehabilitation, Osteoarthritis phenotype, Rehabilitation, Electromyography
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal phenotype-based prehabilitationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op
Secondary outcomes (2)
KOOS score change
Assessment of knee injury and osteoarthritis outcome across multiple domains (symptoms, pain, ADL, sport/recreation, quality of life).
Measured: Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op
Timed Up and Go (TUG) test time
Assessment of dynamic balance and functional mobility, measured in seconds.
Measured: Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Jan 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samara State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dmitry Sergeevich Kudashhev, MD, PhD, Associate Professor, Principal investigator, Samara State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790146
- Sponsor's protocol ID
- TKA_PREHAB_2026
- Acronym
- TKA-PREHAB
- Status last verified
- Jan 2026
- First submitted
- 24 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Total Knee Arthroplasty Effectiveness Through Preoperative Correction of Clinical and Functional Disorders Using a Multimodal Phenotype-Based Prehabilitation Approach
- ClinicalTrials.gov ID
- NCT07790146
- Acronym / sponsor ID
- TKA-PREHAB / TKA_PREHAB_2026
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty
- Keywords
- Total knee arthroplasty, Prehabilitation, Osteoarthritis phenotype, Rehabilitation, Electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Samara State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main group (prehabilitation) | Experimental | Procedure: Multimodal phenotype-based prehabilitationPatients (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). |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal phenotype-based prehabilitationA 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. | Procedure or surgery | Main group (prehabilitation) |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
KOOS score change
Time frame: Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op
Timed Up and Go (TUG) test time
Time frame: Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Moseev OI, Kotelnikov GP, Kudashhev DS, et al. Prehabilitation of patients in total knee arthroplasty. XII All-Russian Priorov Forum. Moscow, 2025:167-168.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitry Sergeevich Kudashhev, MD, PhD, Associate Professor principal investigator
Samara State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal phenotype-based prehabilitation in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Samara State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC score change (time frame: Baseline, 72 hours post-op, 4 weeks post-op, 12 weeks post-op). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.