Hip OsteoarthritisEUKINESNCT07448792
EUKINES Wearable Plantar-Pressure Insole System for Rehabilitation After Total Hip Arthroplasty
A study testing Certified reference gait-analysis system, EUKINES plantar-pressure insole system and Structured postoperative rehabilitation program in people with Hip Osteoarthritis and Total Hip Arthroplasty (THA), run by Cardinal Stefan Wyszynski University at 1 site in Poland.
Trial summary
This study evaluates a wearable plantar-pressure insole system (EUKINES) designed to support gait training during postoperative rehabilitation after primary total hip arthroplasty (THA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Total Hip Arthroplasty (THA), Postoperative Rehabilitation
- What is being tested?
- Certified reference gait-analysis system, EUKINES plantar-pressure insole system and Structured postoperative rehabilitation program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 15 Dec 2024to 30 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Scheduled for primary total hip arthroplasty performed for advanced osteoarthritis or other degenerative hip disease.
- Willingness and ability to participate in the 6-week postoperative rehabilitation program and follow-up assessments.
- Ability to understand study information and provide written informed consent.
Who cannot join
- Coexisting medical conditions that may significantly affect rehabilitation outcomes or gait (e.g., severe neurological disorders, major lower-limb joint trauma, other significant musculoskeletal pathology).
- Cognitive impairment or psychiatric conditions that would preclude effective cooperation with the rehabilitation and research team.
- Any contraindication to participation in additional gait training sessions or use of the insole-based gait-analysis systems as judged by the treating physician.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Cardinal Stefan Wyszynski University in Warsaw, Collegium Medicum - Affiliated Orthopaedic Department
Warsaw, Masovian Voivodeship, 01-938
About this study
Official title: Prospective, Randomized, Partially Blinded, Multicenter Non-Inferiority Trial of the EUKINES Wearable Plantar-Pressure Insole Gait-Analysis System for Postoperative Rehabilitation After Primary Total Hip Arthroplasty
This study evaluates a wearable plantar-pressure insole system (EUKINES) designed to support gait training during postoperative rehabilitation after primary total hip arthroplasty (THA). The trial will include 200 adults who are randomly assigned to one of four rehabilitation programs: EUKINES with real-time biofeedback, EUKINES without biofeedback, a certified commercial reference system with biofeedback, or standard rehabilitation without any gait-analysis device. All participants will receive a structured 6-week rehabilitation program after THA, and the only differences between groups concern the use of gait-analysis technology and biofeedback. The main outcomes include changes in plantar-pressure-based gait parameters (mean foot pressure and load asymmetry) and standard clinical scores of hip function and symptoms. The study will also monitor safety, device-related events, walking speed, pain, and patient and therapist ratings of usability and satisfaction. The goal is to determine whether rehabilitation supported by the EUKINES insole system is at least as effective and safe as rehabilitation supported by a certified reference system and as standard care, and to explore the feasibility of using low-cost, printed-sensor technology for routine gait assessment and future telerehabilitation.
Read the detailed description
This is a prospective, randomized, partially blinded, multicenter clinical trial with a non-inferiority design conducted in patients undergoing primary total hip arthroplasty (THA) for advanced osteoarthritis. The study is embedded in the EUKINES project, which develops low-cost, printable pressure sensors and a wearable plantar-pressure insole system intended for scalable clinical rehabilitation and telerehabilitation use. The trial evaluates the clinical performance, safety, and usability of the EUKINES insole system as an adjunct to standard postoperative rehabilitation.
Adult patients scheduled for primary THA will be screened according to predefined inclusion and exclusion criteria and enrolled after providing written informed consent. A total of 200 participants will be randomized in blocks to one of four parallel rehabilitation arms: (1) EUKINES with real-time biofeedback, (2) EUKINES without biofeedback (data recording only), (3) a certified commercial reference gait-analysis system with biofeedback, or (4) standard rehabilitation without any gait-analysis device. All participants will follow the same structured 6-week rehabilitation program after surgery, including routine physiotherapy and six additional, approximately 3-hour gait-focused sessions. The content and duration of rehabilitation are equivalent across groups; only the use of gait-analysis devices and biofeedback differs between arms.
Outcome assessments will be performed at baseline and during postoperative follow-up. Primary endpoints include changes in plantar-pressure-derived gait parameters such as mean foot pressure and load asymmetry between the operated and non-operated limb, as well as changes in hip-related clinical scores (Harris Hip Score and the 12-item Hip Disability and Osteoarthritis Outcome Score, HOOS-12) and the incidence of adverse events and device-related complications. Secondary outcomes include extended spatiotemporal gait parameters, 10-Meter Walk Test performance, pain intensity and satisfaction with surgery and rehabilitation, and patient and therapist ratings of usability, comfort, and perceived usefulness of the EUKINES and reference systems. All plantar-pressure time-series data will be stored to allow post-hoc derivation of additional gait metrics and exploratory analyses.
The study is classified as a low-risk, add-on interventional trial that does not alter standard surgical procedures or baseline postoperative care. Device-assisted rehabilitation sessions are provided as an adjunct to routine practice. The trial is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice, under the oversight of a bioethics committee. By directly comparing the EUKINES prototype with a certified commercial reference system and standard care, the study aims to demonstrate the feasibility and clinical usefulness of an affordable sensor-based gait-analysis platform and to provide a basis for future development of data-driven telerehabilitation and personalized rehabilitation strategies.
- Being tested
- Certified reference gait-analysis system, EUKINES plantar-pressure insole system, Structured postoperative rehabilitation program
- Keywords
- gait analysis, rehabilitation, plantar-pressure insoles, wearable sensors, printed sensors, biofeedback, telerehabilitation, total hip arthroplasty, mean foot pressure, EUKINES
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certified reference gait-analysis systemDevice
Commercially available, certified plantar-pressure gait-analysis system used according to the manufacturer's recommendations to provide real-time biofeedback on gait parameters during rehabilitation sessions.
EUKINES plantar-pressure insole systemDevice
Wearable plantar-pressure insole system developed within the EUKINES project, consisting of thin-film printed pressure sensors, shoe-mounted electronic modules, and PC-based software for real-time gait data acquisition and visualization. In the biofeedback arm, real-time feedback on gait parameters is provided during rehabilitation sessions; in the non-biofeedback arm, data are recorded without feedback.
Structured postoperative rehabilitation programOther
Standard postoperative rehabilitation program after total hip arthroplasty, delivered according to local clinical protocols and including six additional approximately 3-hour gait-focused rehabilitation sessions over 6 weeks, with progressive gait training, balance and coordination exercises, and functional mobility tasks.
| Study group | Role | What they receive |
|---|---|---|
| EUKINES with biofeedback | Experimental | Participants receive the structured postoperative rehabilitation program supported by the EUKINES plantar-pressure insole system with real-time biofeedback on gait parameters during the additional rehabilitation sessions. Receives: Device: EUKINES plantar-pressure insole system; Other: Structured postoperative rehabilitation program |
| EUKINES without biofeedback | Experimental | Participants receive the structured postoperative rehabilitation program while wearing the EUKINES plantar-pressure insole system without real-time biofeedback; gait data are recorded for analysis only during the additional rehabilitation sessions. Receives: Device: EUKINES plantar-pressure insole system; Other: Structured postoperative rehabilitation program |
| Reference system with biofeedback | Active comparator | Participants receive the structured postoperative rehabilitation program supported by a certified commercial plantar-pressure gait-analysis system providing real-time biofeedback on gait parameters during the additional rehabilitation sessions. Receives: Device: Certified reference gait-analysis system; Other: Structured postoperative rehabilitation program |
| Standard rehabilitation | Active comparator | Participants receive the same structured postoperative rehabilitation program without any gait-analysis device or biofeedback; rehabilitation is based on standard clinical practice at participating centers. Receives: Other: Structured postoperative rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean foot pressure (MFP) on the operated limb
Mean foot pressure (MFP) is defined as the average plantar pressure across all active sensing regions of the insole during the stance phase of gait, expressed in kilopascals. MFP will be recorded during standardized 10-meter walking trials using the EUKINES and/or reference insole systems, and session-level MFP will be calculated as the mean value across all valid steps. The primary analysis will compare changes in MFP on the operated limb over time and between rehabilitation arms.
Measured: Baseline (Week 0), Week 3, Week 6 after surgery
Change in load asymmetry between operated and non-operated limb
Load asymmetry will be quantified using plantar-pressure data from the EUKINES and/or reference insole systems as the difference or ratio between mean foot pressure on the operated and non-operated limb during standardized 10-meter walking trials. Reduced inter-limb asymmetry over time will be interpreted as improved functional load distribution after total hip arthroplasty.
Measured: Baseline (Week 0), Week 3, Week 6 after surgery
Change in Harris Hip Score (HHS)
The Harris Hip Score is a validated clinician-administered scale assessing pain, function, range of motion, and absence of deformity in patients after hip surgery. Total scores range from 0 to 100, with higher scores indicating better hip function. The primary analysis will compare changes in HHS from baseline to Week 6 between rehabilitation arms.
Measured: Baseline (preoperative or immediate postoperative) and Week 6 after surgery
Change in HOOS-12 total score
The HOOS-12 is a validated 12-item short form of the Hip Disability and Osteoarthritis Outcome Score that assesses pain, function, and quality of life in hip patients. Scores are transformed to a 0-100 scale, with higher scores indicating better outcomes. The main analysis will evaluate changes in HOOS-12 total score from baseline to Week 6, with reference to the minimal clinically important difference of approximately 9-12 points reported in the literature.
Measured: Baseline (preoperative or immediate postoperative) and Week 6 after surgery
Incidence of adverse events and device-related complications
Safety will be assessed by recording all adverse events, device-related complications, skin irritation, falls, or other medical incidents potentially associated with device use or the supplementary rehabilitation sessions. Events will be classified by severity, relationship to the device or intervention, and outcome.
Measured: From enrollment through Week 6 after surgery
Secondary outcomes (7)
Preferred walking speed (10-Meter Walk Test)
Preferred walking speed over 10 meters will be measured in m/s during standardized 10-Meter Walk Tests; changes over time and between groups will be analyzed.
Measured: Baseline, Week 3, Week 6
Change in maximal walking speed (10-Meter Walk Test)
Maximal walking speed over 10 meters will be measured in m/s during standardized 10-Meter Walk Tests; changes over time and between groups will be analyzed.
Measured: Baseline, Week 3, Week 6
Change in spatiotemporal gait parameters derived from plantar-pressure insoles
Baseline, Week 3, Week 6
Measured: Additional gait parameters (e.g., cadence, stance and swing phase duration, rollover time) will be derived from plantar-pressure time-series data and analyzed as exploratory secondary outcomes.
Change in hip pain intensity (VAS)
Hip pain will be rated on a visual analogue scale (0-10), with higher scores indicating greater pain; changes over time and between groups will be compared.
Measured: Baseline, Week 3, Week 6
Change in patient satisfaction with surgery and rehabilitation measured with a Visual Analogue Scale (VAS)
Patient satisfaction with surgery and postoperative rehabilitation will be assessed using a 100-mm Visual Analogue Scale (VAS) ranging from 0 to 100, where 0 indicates "not satisfied at all" (worst possible satisfaction) and 100 indicates "extremely satisfied" (best possible satisfaction). The VAS score (points, 0-100; higher scores indicate better satisfaction) will be recorded at Week 3 and Week 6 after surgery, and changes over time and between study groups will be compared
Measured: Week 3 and Week 6
Patient-reported usability and comfort of the EUKINES and reference systems (study-specific 15-item Likert-scale questionnaire)
Patient-reported usability and comfort of the EUKINES system and the reference system will be assessed with a study-specific EUKINES Usability and Comfort Questionnaire developed by the investigators, consisting of 15 items rated on a 5-point Likert scale (0 = strongly disagree, 4 = strongly agree). For each system, an overall usability and comfort score will be calculated as the mean of all item scores and expressed in points (range 0-4; higher scores indicate better usability and greater comfort). Scores will be collected at Week 3 and Week 6 after surgery, and changes over time and between study groups will be compared.
Measured: Week 3 and Week 6
Therapist-reported usability and perceived usefulness of the EUKINES and reference systems (study-specific 12-item Likert-scale questionnaire)
Therapist-reported usability and perceived usefulness of the EUKINES system and the reference system will be assessed with a study-specific EUKINES Therapist Usability and Usefulness Questionnaire developed by the investigators, consisting of 12 items rated on a 5-point Likert scale (0 = strongly disagree, 4 = strongly agree). Two summary scores will be calculated for each system: a usability score and a perceived usefulness score, each expressed in points as the mean of the corresponding items (range 0-4; higher scores indicate better usability or greater perceived usefulness). Scores collected throughout the 6-week rehabilitation period will be analyzed as repeated measures and compared between systems and between study groups.
Measured: Throughout the 6-week rehabilitation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start15 Dec 2024
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip 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
- Model description
- Four-arm parallel-group trial with patients allocated to EUKINES with biofeedback, EUKINES without biofeedback, a certified reference gait-analysis system with biofeedback, or standard rehabilitation without a gait-analysis device.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardinal Stefan Wyszynski University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research and Development, Poland, Warsaw University of Technology
- Responsible party
- Sponsor
- Investigators
- Andrzej Kotela, Principal investigator, Cardinal Stefan Wyszynski University in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448792
- Sponsor's protocol ID
- UKSW/EUKINES-THA-01
- Other IDs
- TECHMATSTRATEG-III-0032-2019
- Acronym
- EUKINES
- Status last verified
- Mar 2026
- First submitted
- 11 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because there is no dedicated infrastructure or funding for long-term controlled access data sharing beyond the requirements for publication and regulatory reporting.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Partially Blinded, Multicenter Non-Inferiority Trial of the EUKINES Wearable Plantar-Pressure Insole Gait-Analysis System for Postoperative Rehabilitation After Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT07448792
- Acronym / sponsor ID
- EUKINES / UKSW/EUKINES-THA-01
- Keywords
- gait analysis, rehabilitation, plantar-pressure insoles, wearable sensors, printed sensors, biofeedback, telerehabilitation, total hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cardinal Stefan Wyszynski UniversityUniversity, hospital or other
- Collaborators
- National Center for Research and Development, Poland, Warsaw University of Technology
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 4 Mar 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.
This study evaluates a wearable plantar-pressure insole system (EUKINES) designed to support gait training during postoperative rehabilitation after primary total hip arthroplasty (THA). The trial will include 200 adults who are randomly assigned to one of four rehabilitation programs: EUKINES with real-time biofeedback, EUKINES without biofeedback, a certified commercial reference system with biofeedback, or standard rehabilitation without any gait-analysis device. All participants will receive a structured 6-week rehabilitation program after THA, and the only differences between groups concern the use of gait-analysis technology and biofeedback. The main outcomes include changes in plantar-pressure-based gait parameters (mean foot pressure and load asymmetry) and standard clinical scores of hip function and symptoms. The study will also monitor safety, device-related events, walking speed, pain, and patient and therapist ratings of usability and satisfaction. The goal is to determine whether rehabilitation supported by the EUKINES insole system is at least as effective and safe as rehabilitation supported by a certified reference system and as standard care, and to explore the feasibility of using low-cost, printed-sensor technology for routine gait assessment and future telerehabilitation.
Detailed description
This is a prospective, randomized, partially blinded, multicenter clinical trial with a non-inferiority design conducted in patients undergoing primary total hip arthroplasty (THA) for advanced osteoarthritis. The study is embedded in the EUKINES project, which develops low-cost, printable pressure sensors and a wearable plantar-pressure insole system intended for scalable clinical rehabilitation and telerehabilitation use. The trial evaluates the clinical performance, safety, and usability of the EUKINES insole system as an adjunct to standard postoperative rehabilitation.
Adult patients scheduled for primary THA will be screened according to predefined inclusion and exclusion criteria and enrolled after providing written informed consent. A total of 200 participants will be randomized in blocks to one of four parallel rehabilitation arms: (1) EUKINES with real-time biofeedback, (2) EUKINES without biofeedback (data recording only), (3) a certified commercial reference gait-analysis system with biofeedback, or (4) standard rehabilitation without any gait-analysis device. All participants will follow the same structured 6-week rehabilitation program after surgery, including routine physiotherapy and six additional, approximately 3-hour gait-focused sessions. The content and duration of rehabilitation are equivalent across groups; only the use of gait-analysis devices and biofeedback differs between arms.
Outcome assessments will be performed at baseline and during postoperative follow-up. Primary endpoints include changes in plantar-pressure-derived gait parameters such as mean foot pressure and load asymmetry between the operated and non-operated limb, as well as changes in hip-related clinical scores (Harris Hip Score and the 12-item Hip Disability and Osteoarthritis Outcome Score, HOOS-12) and the incidence of adverse events and device-related complications. Secondary outcomes include extended spatiotemporal gait parameters, 10-Meter Walk Test performance, pain intensity and satisfaction with surgery and rehabilitation, and patient and therapist ratings of usability, comfort, and perceived usefulness of the EUKINES and reference systems. All plantar-pressure time-series data will be stored to allow post-hoc derivation of additional gait metrics and exploratory analyses.
The study is classified as a low-risk, add-on interventional trial that does not alter standard surgical procedures or baseline postoperative care. Device-assisted rehabilitation sessions are provided as an adjunct to routine practice. The trial is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice, under the oversight of a bioethics committee. By directly comparing the EUKINES prototype with a certified commercial reference system and standard care, the study aims to demonstrate the feasibility and clinical usefulness of an affordable sensor-based gait-analysis platform and to provide a basis for future development of data-driven telerehabilitation and personalized rehabilitation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Four-arm parallel-group trial with patients allocated to EUKINES with biofeedback, EUKINES without biofeedback, a certified reference gait-analysis system with biofeedback, or standard rehabilitation without a gait-analysis device.
| Arm | Type | Receives |
|---|---|---|
| EUKINES with biofeedback | Experimental | Device: EUKINES plantar-pressure insole system, Other: Structured postoperative rehabilitation programParticipants receive the structured postoperative rehabilitation program supported by the EUKINES plantar-pressure insole system with real-time biofeedback on gait parameters during the additional rehabilitation sessions. |
| EUKINES without biofeedback | Experimental | Device: EUKINES plantar-pressure insole system, Other: Structured postoperative rehabilitation programParticipants receive the structured postoperative rehabilitation program while wearing the EUKINES plantar-pressure insole system without real-time biofeedback; gait data are recorded for analysis only during the additional rehabilitation sessions. |
| Reference system with biofeedback | Active comparator | Device: Certified reference gait-analysis system, Other: Structured postoperative rehabilitation programParticipants receive the structured postoperative rehabilitation program supported by a certified commercial plantar-pressure gait-analysis system providing real-time biofeedback on gait parameters during the additional rehabilitation sessions. |
| Standard rehabilitation | Active comparator | Other: Structured postoperative rehabilitation programParticipants receive the same structured postoperative rehabilitation program without any gait-analysis device or biofeedback; rehabilitation is based on standard clinical practice at participating centers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Scheduled for primary total hip arthroplasty performed for advanced osteoarthritis or other degenerative hip disease.
- Willingness and ability to participate in the 6-week postoperative rehabilitation program and follow-up assessments.
- Ability to understand study information and provide written informed consent.
Key exclusion criteria (3 listed)
- Coexisting medical conditions that may significantly affect rehabilitation outcomes or gait (e.g., severe neurological disorders, major lower-limb joint trauma, other significant musculoskeletal pathology).
- Cognitive impairment or psychiatric conditions that would preclude effective cooperation with the rehabilitation and research team.
- Any contraindication to participation in additional gait training sessions or use of the insole-based gait-analysis systems as judged by the treating physician.
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 |
|---|---|---|
| Certified reference gait-analysis systemCommercially available, certified plantar-pressure gait-analysis system used according to the manufacturer's recommendations to provide real-time biofeedback on gait parameters during rehabilitation sessions. | Device | Reference system with biofeedback |
| EUKINES plantar-pressure insole systemWearable plantar-pressure insole system developed within the EUKINES project, consisting of thin-film printed pressure sensors, shoe-mounted electronic modules, and PC-based software for real-time gait data acquisition and visualization. In the biofeedback arm, real-time feedback on gait parameters is provided during rehabilitation sessions; in the non-biofeedback arm, data are recorded without feedback. | Device | EUKINES with biofeedback, EUKINES without biofeedback |
| Structured postoperative rehabilitation programStandard postoperative rehabilitation program after total hip arthroplasty, delivered according to local clinical protocols and including six additional approximately 3-hour gait-focused rehabilitation sessions over 6 weeks, with progressive gait training, balance and coordination exercises, and functional mobility tasks. | Other | EUKINES with biofeedback, EUKINES without biofeedback, Reference system with biofeedback, Standard rehabilitation |
Primary outcome
Change in mean foot pressure (MFP) on the operated limb
Time frame: Baseline (Week 0), Week 3, Week 6 after surgery
Mean foot pressure (MFP) is defined as the average plantar pressure across all active sensing regions of the insole during the stance phase of gait, expressed in kilopascals. MFP will be recorded during standardized 10-meter walking trials using the EUKINES and/or reference insole systems, and session-level MFP will be calculated as the mean value across all valid steps. The primary analysis will compare changes in MFP on the operated limb over time and between rehabilitation arms.
Change in load asymmetry between operated and non-operated limb
Time frame: Baseline (Week 0), Week 3, Week 6 after surgery
Load asymmetry will be quantified using plantar-pressure data from the EUKINES and/or reference insole systems as the difference or ratio between mean foot pressure on the operated and non-operated limb during standardized 10-meter walking trials. Reduced inter-limb asymmetry over time will be interpreted as improved functional load distribution after total hip arthroplasty.
Change in Harris Hip Score (HHS)
Time frame: Baseline (preoperative or immediate postoperative) and Week 6 after surgery
The Harris Hip Score is a validated clinician-administered scale assessing pain, function, range of motion, and absence of deformity in patients after hip surgery. Total scores range from 0 to 100, with higher scores indicating better hip function. The primary analysis will compare changes in HHS from baseline to Week 6 between rehabilitation arms.
Change in HOOS-12 total score
Time frame: Baseline (preoperative or immediate postoperative) and Week 6 after surgery
The HOOS-12 is a validated 12-item short form of the Hip Disability and Osteoarthritis Outcome Score that assesses pain, function, and quality of life in hip patients. Scores are transformed to a 0-100 scale, with higher scores indicating better outcomes. The main analysis will evaluate changes in HOOS-12 total score from baseline to Week 6, with reference to the minimal clinically important difference of approximately 9-12 points reported in the literature.
Incidence of adverse events and device-related complications
Time frame: From enrollment through Week 6 after surgery
Safety will be assessed by recording all adverse events, device-related complications, skin irritation, falls, or other medical incidents potentially associated with device use or the supplementary rehabilitation sessions. Events will be classified by severity, relationship to the device or intervention, and outcome.
7 secondary outcomes
Preferred walking speed (10-Meter Walk Test)
Time frame: Baseline, Week 3, Week 6
Change in maximal walking speed (10-Meter Walk Test)
Time frame: Baseline, Week 3, Week 6
Change in spatiotemporal gait parameters derived from plantar-pressure insoles
Time frame: Additional gait parameters (e.g., cadence, stance and swing phase duration, rollover time) will be derived from plantar-pressure time-series data and analyzed as exploratory secondary outcomes.
Change in hip pain intensity (VAS)
Time frame: Baseline, Week 3, Week 6
Change in patient satisfaction with surgery and rehabilitation measured with a Visual Analogue Scale (VAS)
Time frame: Week 3 and Week 6
Patient-reported usability and comfort of the EUKINES and reference systems (study-specific 15-item Likert-scale questionnaire)
Time frame: Week 3 and Week 6
Therapist-reported usability and perceived usefulness of the EUKINES and reference systems (study-specific 12-item Likert-scale questionnaire)
Time frame: Throughout the 6-week rehabilitation period
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 4 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because there is no dedicated infrastructure or funding for long-term controlled access data sharing beyond the requirements for publication and regulatory reporting.
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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.
Andrzej Kotela principal investigator
Cardinal Stefan Wyszynski University in Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Certified reference gait-analysis system, EUKINES plantar-pressure insole system and Structured postoperative rehabilitation program in people with Hip Osteoarthritis and Total Hip Arthroplasty (THA), run by Cardinal Stefan Wyszynski University at 1 site in Poland.
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 4 inclusion and 3 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 4 Mar 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 Poland. 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?
Change in mean foot pressure (MFP) on the operated limb (time frame: Baseline (Week 0), Week 3, Week 6 after surgery). The study lists 5 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 4 Mar 2026.