Knee OsteoarthritisPROTEKTNCT06290336
Pre-Operative Exercise Therapy and Patient Education Before Total Knee Replacement
A study testing Pre-operative exercise therapy and education and Standardized pre-operative information session in people with Knee Osteoarthritis, run by Linkoeping University at 1 site in Sweden.
Trial summary
The goal of this multi-center randomized controlled trial is to investigate the effect of pre-operative exercise therapy and education for patients awaiting knee replacement surgery on subjective knee function, patient satisfaction and enablement compared to standard care. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Pre-operative exercise therapy and education and Standardized pre-operative information session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSweden
- Study dates
- 26 Feb 2024to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Waiting list for primary unilateral knee replacement surgery
- Osteoarthritis of the knee being the primary reason for surgery
- Reside within 60 minutes of travel to the site of the intervention
Who cannot join
- Previous knee replacement surgery in the other knee
- Other reason than osteoarthritis of the knee as the primary reason for surgery
- Impaired cognitive function
- Not being independent speaking and reading in swedish language
- Chronic illness or disability etc hindering full participation in the intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Linkoping University
Linköping, Östergötland County, 58183
Joanna Kvist, Professor, +46 (0) 13 284664, joanna.kvist@liu.se
Joanna Kvist, Professor
About this study
Official title: Effect of Prehabilitation Before Total Knee Replacement on Post-operative Patient-reported Joint Awareness, Enablement and Knee Function
The goal of this multi-center randomized controlled trial is to investigate the effect of pre-operative exercise therapy and education for patients awaiting knee replacement surgery on subjective knee function, patient satisfaction and enablement compared to standard care.
The main questions it aims to answer are:
Read more
- Does pre-operative exercise therapy and education lead to better subjective knee function compared to standard care one year after surgery?
- Does pre-operative exercise therapy and education lead to a higher level of patient satisfaction compared to standard care one year after surgery?
- Does pre-operative exercise therapy and education lead to better patient enablement compared to standard care six weeks after surgery?
- Does pre-operative exercise therapy and education lead to better objective knee function compared to standard care six weeks after surgery?
Participants will be randomized stratified by age (≤ 67 years, > 67 years) to either pre-operative supervised individualized exercise therapy combined with education two sessions/week (intervention group) or to standard care (control group). The intervention will be continuously ongoing for at least eight weeks from the point of decision for surgery until as close to the surgery as possible.
Read the detailed description
Eligible patients will be randomized through opaque concealed envelopes stratified by age (≤ 67 years, > 67 years) with a 1:1 allocation ratio into the intervention or the control group, after getting a decision for surgery from the surgeon. Inclusion and exclusion criteria are described in a section below. The envelopes and allocation list will be kept in a locked fire-proof storage in a different building than where the allocation process will take place.
The patients in the intervention group will participate in pre-operative supervised exercise therapy and education, continuously ongoing from point of surgery decision until surgery. Twice a week, approximately one hour/session. Training consists of individualized strength, balance and mobility exercises, and education consists of ongoing individualized discussion regarding patients' expectations of post-operative recovery, pain and swelling, course of rehabilitation, long term function and activity level etc.
Patients in both groups will participate in a standardized pre-operative information session, approximately 2 weeks before surgery. General information regarding preparations before surgery (e.g. preparing the home environment), events during the hospital stay and the rehabilitation process after discharge will be provided as part of the standard care procedure.
Patients in the control group will participate in the standardized pre-operative information session mentioned above. They will not receive any specific information regarding training and exercise or individualized education outside of regular discussion with the surgeon when consenting to/making the decision for surgery.
Baseline and follow-up measures after 8 weeks, 1-2 weeks before surgery and 6 weeks after surgery will include objective and patient reported outcome measures. Follow-up measures 3 months and 1 year after surgery will consist of patient reported outcome measures only.
- Conditions
- Knee Osteoarthritis
- Being tested
- Pre-operative exercise therapy and education, Standardized pre-operative information session
- Keywords
- Knee replacement, Exercise therapy, Education, Knee function, Satisfaction
- Medical subject headings
- Osteoarthritis, Knee, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative exercise therapy and educationOther
Pre-operative supervised exercise therapy consisting of individualized strength, mobility and balance exercises and continuous education through individual discussions of expectations of post-operative recovery, pain and swelling, course of rehabilitation, long term function and activity level etc. Twice a week, approximately one hour/session.
Standardized pre-operative information sessionOther
As part of the standard care procedure, patients in the intervention and control group will participate in a standardized pre-operative information session approximately 2 weeks before surgery. General information regarding preparations before surgery (e.g. preparing the home environment), events during the hospital stay and the rehabilitation process after discharge will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Pre-operative exercise therapy and education before knee replacement surgery Receives: Other: Pre-operative exercise therapy and education; Other: Standardized pre-operative information session |
| Control group | Other | Standard care Receives: Other: Standardized pre-operative information session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forgotten Joint Score-12 (FJS-12) from baseline to 1 year after surgery
Patient-reported outcome measure (PROM) where patients assesses how aware they are of their affected knee on a 5 item Likert scale in 12 different situations in daily living. The result is summarized into a total result on a 0-100 scale, with 0 being worst (high awareness) and 100 being best (low awareness)
Measured: Baseline; 1 year after surgery
Change in modified Patient Enablement Instrument-2 (Mod-PEI-2) from baseline to 6 weeks after surgery
6-item PROM where patients are asked to assess their ability to cope with life, understand and cope with their disease, ability to stay healthy and help themselves etc during the last 4 weeks. Items are answered in a 5-item Likert scale ranging from extremely well to not at all. Results are summarized into a total score from 6 to 30, with higher scores indicating better enablement.
Measured: Baseline; 6 weeks after surgery
Secondary outcomes (13)
Patient satisfaction at 1 year after surgery
5 item Likert scale ranging from very dissatisfied to very satisfied
Measured: 1 year after surgery
Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery
Seated, using fixed dynamometer
Measured: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery
Change in active knee range of motion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery
Supine, using goniometer
Measured: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery
Change in 30sCST from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery
Maximal number of completed repetitions in 30 seconds
Measured: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery
Change in Knee Osteoarthritis Outcome Score (KOOS) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery
PROM with 5 sub-categories on different topics regarding pain, symptoms, activities in daily living, sports and recreation and quality of life. Results are summarized in a 0-100 scale with 0 being worst and 100 best
Measured: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery; 1 year after surgery
Change in 30 seconds Chair to Stand-Test (30sCST) from baseline to 6 weeks after surgery
Maximal number of completed repetitions in 30 seconds
Measured: Baseline; 6 weeks after surgery
Change in active knee range of motion from baseline to 6 weeks after surgery
Supine, using goniometer
Measured: Baseline; 6 weeks after surgery
Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 6 weeks after surgery
Seated, using fixed dynamometer
Measured: Baseline; 6 weeks after surgery
: Change in EuroQol 5 Dimensions 3 Levels (EQ5D-3L) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery
PROM in five dimensions on different topics of state of health answered in a three-level scale. Values are anchored at 1 (full health) and 0 (a state as bad as being dead), allowing also negative values. The outcome also includes a grading of the patients' perceived state of health on a Visual Analogue Scale (VAS) 0-100, with 0 being worst possible state of health and 100 being best possible state of health
Measured: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery; 1 year after surgery
Change in International Physical Activity Questionnaire - short form (IPAQ-sf) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery
PROM in 4 sub-categories with follow-up questions where patients assess their physical activity habits. Results are summarized into three categories; low, moderate or high physical activity
Measured: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery; 1 year after surgery
Change in Mod-PEI-2 from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery
6-item PROM where patients are asked to assess their ability to cope with life, understand and cope with their disease, ability to stay healthy and help themselves etc during the last 4 weeks. Items are answered in a 5-item Likert scale ranging from extremely well to not at all. Results are summarized into a total score from 6 to 30, with higher scores indicating better enablement.
Measured: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 3 months after surgery; 1 year after surgery
Change in FJS-12 from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery and 6 weeks and 3 months after surgery
PROM where patients assess how aware they are of their affected knee on a 5 item Likert scale in 12 different situations in daily living. The result is summarized into a total result on a 0-100 scale, with 0 being worst (high awareness) and 100 being best (low awareness)
Measured: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery
Change in objectively measured physical activity and sedentary habits via accelerometer, from baseline to 8 weeks after start of intervention, 3 months and 1 year after surgery
Physical activity and sedentary habits is objectively measured via the activPAL™ accelerometer. It is attached to the front of the thigh of the affected leg and is worn 24 hours a day for 7 days.
Measured: Baseline; 8 weeks after randomization/start of intervention; 3 months after surgery; 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start26 Feb 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- Multi-center randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Region Östergötland, Region Jönköping County
- Responsible party
- Principal investigator, Joanna Kvist, Linkoeping University
- Investigators
- Marcus Ljung, PhD-student, Study director, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290336
- Sponsor's protocol ID
- PROTEKT
- Acronym
- PROTEKT
- Status last verified
- Jan 2026
- First submitted
- 22 Feb 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that supports the findings of this study will be available on aggregated level from the corresponding author (ML) upon reasonable request after study completion
Publications
Ljung M, Gustafsson K, Kvist J. Effect of prehabilitation before total knee replacement on postoperative patient-reported joint awareness, enablement and knee function: protocol for the PROTEKT randomised controlled trial. BMJ Open. 2026 Mar 3;16(3):e113185. doi: 10.1136/bmjopen-2025-113185.
PubMed 41775488
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prehabilitation Before Total Knee Replacement on Post-operative Patient-reported Joint Awareness, Enablement and Knee Function
- ClinicalTrials.gov ID
- NCT06290336
- Acronym / sponsor ID
- PROTEKT / PROTEKT
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee replacement, Exercise therapy, Education, Knee function, Satisfaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Region Östergötland, Region Jönköping County
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 4 Mar 2024 (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.
The goal of this multi-center randomized controlled trial is to investigate the effect of pre-operative exercise therapy and education for patients awaiting knee replacement surgery on subjective knee function, patient satisfaction and enablement compared to standard care.
The main questions it aims to answer are:
- Does pre-operative exercise therapy and education lead to better subjective knee function compared to standard care one year after surgery?
- Does pre-operative exercise therapy and education lead to a higher level of patient satisfaction compared to standard care one year after surgery?
- Does pre-operative exercise therapy and education lead to better patient enablement compared to standard care six weeks after surgery?
- Does pre-operative exercise therapy and education lead to better objective knee function compared to standard care six weeks after surgery?
Participants will be randomized stratified by age (≤ 67 years, > 67 years) to either pre-operative supervised individualized exercise therapy combined with education two sessions/week (intervention group) or to standard care (control group). The intervention will be continuously ongoing for at least eight weeks from the point of decision for surgery until as close to the surgery as possible.
Detailed description
Eligible patients will be randomized through opaque concealed envelopes stratified by age (≤ 67 years, > 67 years) with a 1:1 allocation ratio into the intervention or the control group, after getting a decision for surgery from the surgeon. Inclusion and exclusion criteria are described in a section below. The envelopes and allocation list will be kept in a locked fire-proof storage in a different building than where the allocation process will take place.
The patients in the intervention group will participate in pre-operative supervised exercise therapy and education, continuously ongoing from point of surgery decision until surgery. Twice a week, approximately one hour/session. Training consists of individualized strength, balance and mobility exercises, and education consists of ongoing individualized discussion regarding patients' expectations of post-operative recovery, pain and swelling, course of rehabilitation, long term function and activity level etc.
Patients in both groups will participate in a standardized pre-operative information session, approximately 2 weeks before surgery. General information regarding preparations before surgery (e.g. preparing the home environment), events during the hospital stay and the rehabilitation process after discharge will be provided as part of the standard care procedure.
Patients in the control group will participate in the standardized pre-operative information session mentioned above. They will not receive any specific information regarding training and exercise or individualized education outside of regular discussion with the surgeon when consenting to/making the decision for surgery.
Baseline and follow-up measures after 8 weeks, 1-2 weeks before surgery and 6 weeks after surgery will include objective and patient reported outcome measures. Follow-up measures 3 months and 1 year after surgery will consist of patient reported outcome measures only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-center randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Pre-operative exercise therapy and education, Other: Standardized pre-operative information sessionPre-operative exercise therapy and education before knee replacement surgery |
| Control group | Other | Other: Standardized pre-operative information sessionStandard care |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Waiting list for primary unilateral knee replacement surgery
- Osteoarthritis of the knee being the primary reason for surgery
- Reside within 60 minutes of travel to the site of the intervention
Key exclusion criteria (5 listed)
- Previous knee replacement surgery in the other knee
- Other reason than osteoarthritis of the knee as the primary reason for surgery
- Impaired cognitive function
- Not being independent speaking and reading in swedish language
- Chronic illness or disability etc hindering full participation in the intervention
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 |
|---|---|---|
| Pre-operative exercise therapy and educationPre-operative supervised exercise therapy consisting of individualized strength, mobility and balance exercises and continuous education through individual discussions of expectations of post-operative recovery, pain and swelling, course of rehabilitation, long term function and activity level etc. Twice a week, approximately one hour/session. | Other | Intervention group |
| Standardized pre-operative information sessionAs part of the standard care procedure, patients in the intervention and control group will participate in a standardized pre-operative information session approximately 2 weeks before surgery. General information regarding preparations before surgery (e.g. preparing the home environment), events during the hospital stay and the rehabilitation process after discharge will be provided. | Other | Control group, Intervention group |
Primary outcome
Change in Forgotten Joint Score-12 (FJS-12) from baseline to 1 year after surgery
Time frame: Baseline; 1 year after surgery
Patient-reported outcome measure (PROM) where patients assesses how aware they are of their affected knee on a 5 item Likert scale in 12 different situations in daily living. The result is summarized into a total result on a 0-100 scale, with 0 being worst (high awareness) and 100 being best (low awareness)
Change in modified Patient Enablement Instrument-2 (Mod-PEI-2) from baseline to 6 weeks after surgery
Time frame: Baseline; 6 weeks after surgery
6-item PROM where patients are asked to assess their ability to cope with life, understand and cope with their disease, ability to stay healthy and help themselves etc during the last 4 weeks. Items are answered in a 5-item Likert scale ranging from extremely well to not at all. Results are summarized into a total score from 6 to 30, with higher scores indicating better enablement.
13 secondary outcomes
Patient satisfaction at 1 year after surgery
Time frame: 1 year after surgery
Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery
Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery
Change in active knee range of motion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery
Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery
Change in 30sCST from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery
Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery
Change in Knee Osteoarthritis Outcome Score (KOOS) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery
Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery; 1 year after surgery
Change in 30 seconds Chair to Stand-Test (30sCST) from baseline to 6 weeks after surgery
Time frame: Baseline; 6 weeks after surgery
Change in active knee range of motion from baseline to 6 weeks after surgery
Time frame: Baseline; 6 weeks after surgery
Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 6 weeks after surgery
Time frame: Baseline; 6 weeks after surgery
: Change in EuroQol 5 Dimensions 3 Levels (EQ5D-3L) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery
Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery; 1 year after surgery
Change in International Physical Activity Questionnaire - short form (IPAQ-sf) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery
Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery; 1 year after surgery
Change in Mod-PEI-2 from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery
Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 3 months after surgery; 1 year after surgery
Change in FJS-12 from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery and 6 weeks and 3 months after surgery
Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery
Change in objectively measured physical activity and sedentary habits via accelerometer, from baseline to 8 weeks after start of intervention, 3 months and 1 year after surgery
Time frame: Baseline; 8 weeks after randomization/start of intervention; 3 months after surgery; 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Derived from this study: PubMed 41775488Ljung M, Gustafsson K, Kvist J. Effect of prehabilitation before total knee replacement on postoperative patient-reported joint awareness, enablement and knee function: protocol for the PROTEKT randomised controlled trial. BMJ Open. 2026 Mar 3;16(3):e113185. doi: 10.1136/bmjopen-2025-113185.
- Individual participant dataSharing planned: No. The data that supports the findings of this study will be available on aggregated level from the corresponding author (ML) upon reasonable request after study completion
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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.
Marcus Ljung, PhD-student study director
Linkoeping 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 Pre-operative exercise therapy and education and Standardized pre-operative information session in people with Knee Osteoarthritis, run by Linkoeping University at 1 site in Sweden.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Feb 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcus Ljung, PhD-student (+4610-1043861, marcus.ljung@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Forgotten Joint Score-12 (FJS-12) from baseline to 1 year after surgery (time frame: Baseline; 1 year after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06290336, which also lists 1 linked publication.
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 3 Feb 2026.