Digitally Supported Short-Term Prehabilitation Before Total Knee Replacement (P2R-KneeTEP)

Prehab2Rehab: Digitally Supported Short-Term Prehabilitation Before Total Knee Replacement - A Randomized Controlled Feasibility Trial

This study evaluates the feasibility of a short-term, digitally supported prehabilitation program for patients scheduled for elective total knee replacement (TKR). Osteoarthritis is a leading cause of disability, and recovery following TKR remains heterogeneous, with a substantial proportion of patients experiencing delayed functional recovery. Prehabilitation may improve perioperative outcomes, but its implementation is often limited by short preoperative time windows.

The Prehab2Rehab-KneeTEP trial is a single-center, two-arm, randomized controlled feasibility study conducted in Austria. Patients will be randomized (1:1) to either a multimodal video-supported prehabilitation program or usual care. The intervention consists of a 10 to 14-day preoperative exercise program including strength, endurance, coordination, and gait training, supported by a digital application, and is complemented by a digitally supported transition phase after hospital discharge until the start of inpatient rehabilitation.

The primary objective is to assess feasibility in terms of recruitment, retention, adherence, fidelity, acceptability, and safety. Secondary exploratory outcomes include clinical recovery indicators, functional performance, and patient-reported outcomes assessed across the perioperative pathway.

Study Overview

• Status: Not yet recruiting
• Conditions: Total Knee Replacement; Knee Osteoarthristis
• Intervention / Treatment: Other: Usual Care Group; Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Detailed Description

Total knee replacement (TKR) is an effective treatment for advanced knee osteoarthritis, yet postoperative recovery remains heterogeneous, with a substantial proportion of patients experiencing persistent functional limitations. Prehabilitation has the potential to optimize patients' physical and psychological readiness before surgery. However, in clinical practice, prehabilitation is often constrained by limited time between surgical indication and procedure. Digitally supported interventions may offer a feasible solution to deliver structured programs within short timeframes while supporting continuity of care across the perioperative pathway.

The Prehab2Rehab-KneeTEP trial is a single-center, randomized, two-arm feasibility study conducted at the Medizinisches Zentrum Bad Vigaun, Austria. The study aims to evaluate the feasibility, acceptability, and safety of a short-term, digitally supported prehabilitation intervention in patients scheduled for elective TKR.

Eligible patients with advanced knee osteoarthritis will be randomized in a 1:1 ratio following baseline assessment (PRE1) to either (i) a multimodal video-supported prehabilitation intervention with an additional digitally supported transition phase or (ii) usual care. Randomization will be performed using computer-generated permuted blocks with stratification for sex and baseline functional capacity assessed by the 6-minute walk test.

The intervention consists of a 10 to 14-day prehabilitation phase prior to surgery, including endurance, resistance, coordination, and gait training. The program is delivered through a combination of in-person instruction and home-based training supported by a digital application (aktivplan), which provides structured exercise guidance and enables documentation of adherence. A teleconsultation via a secure video platform (CAATS) is conducted to ensure exercise safety, provide feedback, and support progression. Sensor-based systems may be used for documentation and research-related measurements but are not used for clinical decision-making.

Following surgery and hospital discharge, participants in the intervention group enter a digitally supported transition phase lasting approximately 10 to 14 days until the start of inpatient rehabilitation (REH1). During this period, patients receive low-threshold exercise guidance and educational content via the digital application to support early recovery, maintain mobility, and promote self-efficacy. Participants in both groups receive standard surgical care and standardized inpatient rehabilitation according to institutional and national guidelines.

The total study participation duration is approximately 47 to 61 days, covering prehabilitation, hospital stay, transition, and rehabilitation phases. Outcomes are assessed at predefined time points along the perioperative pathway, including baseline (PRE1), end of prehabilitation (PRE2), hospital discharge, start of rehabilitation (REH1), and end of rehabilitation (REH2).

The primary objective is to assess feasibility across multiple domains, including recruitment, retention, adherence, fidelity, acceptability, usability of digital tools, and safety. Feasibility outcomes will be evaluated descriptively across process, resource, management, and participant engagement domains.

Secondary objectives are exploratory and include the assessment of clinical recovery indicators such as length of hospital stay, complication rate, and readmission rate, as well as patient-reported outcomes, anthropometric and body composition parameters, and functional performance measures. Given the feasibility nature of the trial, analyses will be descriptive and hypothesis-generating, without confirmatory statistical testing.

The findings of this study will inform the design and implementation of a future adequately powered randomized controlled trial evaluating the effectiveness of digitally supported prehabilitation in patients undergoing total knee replacement

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniela Wurhofer, Dr.; Phone Number: +43 (0) 57 255 82702; Email: daniela.wurhofer@lbg.ac.at
• Study Contact Backup: Name: Gunnar Treff, Univ.-Prof. Dr.; Phone Number: +43 5 7255 82711; Email: gunnar.treff@pmu.ac.at

Study Locations

• Austria
  • State of Salzburg
    • Hallein, State of Salzburg, Austria, 5424
      • Medizinisches Zentrum Bad Vigaun GmbH & Co. KG
      • Contact: Josef Sturm, Dr.; Phone Number: +43 650 2040605; Email: josef.sturm@badvigaun.com
      • Contact: Hildebert Hutt, Prim. Dr.; Phone Number: +43 6245 8999 673; Email: hildebert.hutt@badvigaun.com
      • Principal Investigator: Hildebert Hutt, Prim. Dr.
      • Principal Investigator: Thomas Hofstädter, Prim. Dr.
      • Sub-Investigator: Josef Sturm, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Eligibility will be determined during the outpatient consultations at the Medical

Center in Bad Vigaun. Patients will be screened against the following criteria:

• Age ≥18 years at the time of enrolment.
• Clinically diagnosed with advanced osteoarthritis and with a medical indication for elective TKR.
• Either a scheduled surgery or a documented intention to undergo TKR within the recruitment period.
• Elective surgery is scheduled for at least 14 days after enrolment to allow completion of the 10 to 14-day prehabilitation intervention.
• Physical ability to safely perform the prescribed exercise program, as confirmed by the treating physician.
• Willingness to participate in a digitally supported training intervention at either the center or home-based.
• Sufficient digital literacy and access to internet-enabled devices (smartphone, tablet, or computer).
• Adequate German language proficiency to follow exercise instructions and study procedures.

Exclusion Criteria:

Patients will be excluded if any of the following apply:

• Pregnancy at the time of enrolment.
• Emergency, revisional, or non-elective surgery.
• Surgery scheduled less than 14 days after enrolment.
• Severe physical impairment or medical contraindication to exercise training (e.g., unstable cardiovascular disease, uncontrolled hypertension, acute musculoskeletal injury).
• Patients with contraindications outlined in the Medizinisches Leistungsprofil (MLP) 2.0 that preclude rehabilitation and/or surgery.
• Participation in another clinical study that could interfere with the intervention or study outcomes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual care; Usual Care (Control). Participants receive standard preoperative, surgical, and postoperative care including standard inpatient rehabilitation without prehabilitation or digital support.	Other: Usual Care Group; Participants allocated to the usual care group will receive the standard perioperative treatment provided at the study site. This includes preoperative consultation, elective total knee replacement surgery according to institutional standards, and routine postoperative care. After hospital discharge, participants return home until the start of standardized inpatient rehabilitation (Phase II), including interdisciplinary care such as physiotherapy, occupational therapy, medical supervision, and health education. No structured prehabilitation or digitally supported intervention will be provided.; Other Names: Usual Care Control Group
Experimental: Multimodal Video-Supported Prehabilitation; Multimodal Video-Supported Prehabilitation plus Digitally Supported Transition. Participants receive a 10 to 14-day multimodal prehabilitation program including endurance, resistance, coordination, and gait training, supported by the aktivplan application, one teleconsultation via CAATS, and research sensors for documentation. Digital support continues during the early post-discharge transition phase with low-threshold exercises and educational content until inpatient rehabilitation begins.	Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION; A short-term multimodal, video-supported prehabilitation program delivered over 10 to 14 days before surgery, including endurance, resistance, coordination, and gait training with crutches. The intervention is introduced during an in-person session and subsequently performed at home using a digital application to provide structured exercise guidance and support adherence. A single teleconsultation is conducted to ensure safety, provide feedback, and allow individualized progression. In addition, digital support is extended into the early post-discharge transition phase, providing low-threshold exercise guidance and educational content to support mobility, self-efficacy, and continuity of care until the start of inpatient rehabilitation.; Other Names: Multimodal Prehabilitation Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	The recruitment rate will be calculated as the percentage of eligible patients who consent to participate in the study. The reported value will be: (number of enrolled participants / number of eligible patients) × 100%.	Continuous throughout the recruitment period (12 months recruitment period)
Retention Rate	Retention will be measured as the percentage of enrolled participants who complete all required study procedures. The reported value will be: (number of participants completing the study / number of enrolled participants) × 100%.	Continuous throughout the data collection period (14 months data collection period)
Adherence to the Intervention	Adherence will be defined as the proportion of prescribed prehabilitation sessions that participants complete. The reported value will be: (number of completed sessions / number of prescribed sessions) × 100%.	During the intervention period (typically 2-4 weeks prior to surgery).
Completeness of Outcome Data	Completeness of data will be assessed as the percentage of planned outcome assessments that are successfully completed and available for analysis. The reported value will be: (number of completed assessments / number of planned assessments) × 100%.	Continuous throughout data collection period (14 months)
Acceptability of the Intervention	Acceptability and usability of the digital intervention will be assessed using the mHealth App Usability Questionnaire (MAUQ). The MAUQ evaluates usability, satisfaction, ease of use, and perceived usefulness of mobile health applications. Items are rated on a 7-point Likert scale, ranging from 1 = strongly disagree to 7 = strongly agree. The outcome will be reported as the mean MAUQ score across completed questionnaires, with higher scores indicating greater perceived usability and acceptability.	At discharge from inpatient rehabilitation (REH2, approximately 6 to 8 weeks after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Assessment Questionnaire (HAQ)	Patient-reported outcome assessing functional ability in activities of daily living using the HAQ score. The instrument captures disability across multiple domains including dressing, arising, eating, walking, hygiene, reach, grip, and common daily activities. Total HAQ scores range from 0 to 3, with higher scores indicating greater functional impairment and lower functional status. The HAQ is used to evaluate changes in patient-reported functional status across the perioperative pathway.	Baseline, prehabilitation discharge (10-14 days after baseline, before surgery), rehabilitation admission (3-4 weeks after surgery), rehabilitation discharge (6-8 weeks after surgery).
Barthel-Index (BI)	Observer-based outcome assessing functional independence in activities of daily living using the Barthel Index (BI). The instrument evaluates performance in domains including feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers, mobility, and stair use. Total BI scores range from 0 to 100, with higher scores indicating greater functional independence and lower dependency. The BI is used to evaluate changes in functional independence across the perioperative pathway.	Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 wk post-surgery), discharge from inpatient rehabilitation (6-8 wk post-surgery)
Oxford Knee Score (OKS)	Patient-reported outcome assessing knee-specific pain and functional status using the OKS score. The instrument captures difficulties in activities such as walking, standing, and rising from a seated position. Scores are calculated according to standard OKS procedures, with higher values indicating better knee function and lower symptom burden. The OKS is used to evaluate changes in knee-related symptoms and function across the perioperative pathway.	Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 wk post-surgery)
Patient Health Questionnaire-4 (PHQ-4)	Patient-reported outcome assessing symptoms of anxiety and depression (PHQ-4). Total score ranges from 0 to 12, with higher values indicating greater psychological distress. Used to monitor changes in psychological well-being across the perioperative pathway.	Baseline (prior to intervention), after completion of prehabilitation (10-14 d after baseline, prior to surgery), admission to inpatient rehabilitation (3-4 wk post-surgery), discharge from inpatient rehabilitation (6-8 wk post-surgery)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Patient-reported outcome assessing knee pain, stiffness, and physical function (WOMAC). Higher scores indicate worse symptoms and functional limitations. Used to evaluate changes across the perioperative rehabilitation pathway.	Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 wks post-surgery), discharge from inpatient rehabilitation (6-8 wks post-surgery).
EuroQol-5 Dimensions-5 Levels (EQ- 5D-5L)	The EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) is a standardized, patient-reported outcome measure assessing health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity. Responses are converted into a health utility index score, with higher values indicating better health status. The instrument also includes a visual analogue scale (EQ-VAS), ranging from 0 to 100, with higher scores indicating better self-rated health.	Baseline (prior to intervention), after prehab intervention (10-14 d after baseline)), discharge (6-12 d post-surgery), admission to inpatient rehabilitation (3-4 wk post-surgery), discharge from inpatient rehabilitation (6-8 wk post-surgery).
Rapid Assessment of Physical Activity (RAPA)	Self-reported questionnaire assessing level of physical activity (RAPA). Scores reflect engagement in aerobic and strength-based physical activity, with higher scores indicating higher activity levels. Used to evaluate changes in physical activity behavior across the perioperative pathway.	Baseline (prior to intervention), and discharge from inpatient rehabilitation (6-8 wks post-surgery).
Exercise Self-Efficacy Scale (ESES)	Exercise Self-Efficacy Scale (ESES). Self-reported measure assessing confidence in the ability to perform and maintain physical activity. Total scores range from 10 to 40, with higher scores indicating greater exercise self-efficacy and therefore a better outcome. Used to evaluate changes in exercise-related confidence across the perioperative pathway.	Baseline (prior to intervention), after prehab intervention (10-14 d after baseline), discharge (6-12 d post-surgery), discharge from inpatient rehabilitation (6-8 wks post-surgery).
Body Fat Mass	Body fat mass measured using bioelectrical impedance analysis (BIA). Body fat mass represents the total amount of body fat and will be reported in kilograms (kg).	Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 wk post-surgery).
Body Lean Mass	Body Lean Mass measured using bioelectrical impedance analysis (BIA). Body Lean Mass represents the total amount of non-fat body tissue and will be reported in kilograms (kg).	Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 wk post-surgery).
Phase Angle	Phase angle measured using bioelectrical impedance analysis (BIA). Phase angle is a marker of cellular integrity and body cell mass and will be reported in degrees (°).	Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 wk post-surgery).
6-Minute Walk Test (6MWT)	The 6-Minute Walk Test (6MWT) is used to assess functional exercise capacity. Participants are instructed to walk as far as possible for six minutes along a standardized corridor, with distance covered recorded in meters. Standardized instructions and encouragement are provided according to established guidelines.	Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 wks post-surgery), discharge from inpatient rehabilitation (6-8 wks post-surgery).
Timed Up and Go Test (TUG)	The Timed Up and Go Test (TUG) assesses functional mobility. Participants are instructed to stand up from a seated position, walk a short distance, turn, return, and sit down, with the total time recorded in seconds under standardized conditions.	Baseline (prior to intervention), after prehab intervention (10-14 d after baseline), admission to inpatient rehabilitation (3-4 wk post-surgery), discharge from inpatient rehabilitation (6-8 wk post-surgery).
Single-Leg Stance (SLS)	The Single-Leg Stance (SLS) test assesses static balance. Participants are instructed to stand on one leg for as long as possible under standardized conditions, with time recorded in seconds.	Baseline (prior to intervention), after prehab intervention (10-14 d after baseline), admission to inpatient rehabilitation (3-4 wk post-surgery), discharge from inpatient rehabilitation (6-8 wk post-surgery).
Fifteen-meter Gait Analysis with crutches (15-mGA+)	The Fifteen-meter Gait Analysis with crutches (15-mGA+) assesses gait performance under assisted walking conditions. Participants walk a standardized distance of 15 meters using crutches, with performance recorded under standardized conditions.	Baseline (prior to intervention), after prehab intervention (10-14 d after baseline), admission to inpatient rehabilitation (3-4 wk post-surgery).
Ten-meter Walk Test without crutches (10-mWT)	The Ten-meter Walk Test without crutches (10-mWT) assesses gait speed. Participants are instructed to walk a standardized distance of 10 meters without assistive devices, with time recorded under standardized conditions.	Baseline (prior to intervention), after prehab intervention (10-14 d after baseline), discharge from inpatient rehabilitation (6-8 wk post-surgery).
Knee Range of Motion (ROM)	Knee Range of Motion (ROM) assesses joint mobility. Range of motion of the knee joint is measured in degrees under standardized conditions.	Baseline (prior to intervention), discharge (6-12 d post-surgery), admission to inpatient rehabilitation (3-4 wks post-surgery), discharge from inpatient rehabilitation (6-8 wks post-surgery).
Lower limb strength (LLS)	Lower limb strength (LLS) assesses muscular strength of the lower extremities. Strength is measured using an isokinetic dynamometer (Biodex) under standardized conditions.	Baseline (prior to intervention), after prehab intervention (10-14 d after baseline), admission to inpatient rehabilitation (3-4 wk post-surgery), discharge from inpatient rehabilitation (6-8 wk post-surgery).
Handgrip strength (HG)	Handgrip strength (HG) assesses upper limb muscle strength using a handheld dynamometer under standardized conditions.	Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 wk post-surgery).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Theory of Acceptance and Use of Technology (UTAUT-2)	Assesses user acceptance and behavioral intention to use digital health technologies, including perceived usefulness, ease of use, and facilitating conditions.	At the discharge from inpatient rehabilitation (6-8 wk post-surgery).
mHealth App Usability Questionnaire (MAUQ)	Usability of the digital intervention will be assessed MAUQ, a validated instrument designed to evaluate usability, ease of use, and satisfaction with mobile health applications. Items are rated on a 7-point Likert scale ranging from 1 = strongly disagree to 7 = strongly agree. Responses are aggregated according to standard scoring procedures to calculate a mean total score, with higher scores indicating greater perceived usability.	At the discharge from inpatient rehabilitation (6-8 wk post-surgery).
Mobile App Rating Scale (MARS)	The quality of the mobile health application will be assessed using the Mobile App Rating Scale (MARS). The instrument includes four domains (engagement, functionality, aesthetics, and information quality), but the outcome will be reported as a single composite score calculated as the mean of all MARS items, each rated on a 5-point Likert scale. Total scores range from 1 to 5, with higher scores indicating better perceived app quality.	At the discharge from inpatient rehabilitation (6-8 wk post-surgery).
Perceived hedonic and pragmatic quality (AttrakDiff)	The AttrakDiff questionnaire assesses user experience of the digital intervention, including pragmatic quality (usability), hedonic quality (stimulation and identification), and overall attractiveness. Items are rated on a 7-point semantic differential scale ranging from -3 to +3. Scores are aggregated according to standard procedures to calculate overall and subscale scores, with higher values indicating more positive user experience.	At the discharge from inpatient rehabilitation (6-8 wk post-surgery).
Affinity for Technology Interaction (ATI)	The Affinity for Technology Interaction (ATI) Scale will be used to measure individuals' tendency to interact with and use technology in daily life. The scale consists of multiple items rated on a 6-point Likert scale (1 = completely disagree to 6 = completely agree). A mean total score will be calculated as the outcome measure. Higher scores indicate greater affinity for technology interaction.	At the discharge from inpatient rehabilitation (6-8 wk post-surgery).
Structured interviews	Structured interviews will be conducted to qualitatively explore patient experiences, acceptability, usability, and perceived usefulness of the digitally supported intervention throughout the perioperative pathway. Interview responses will be analyzed descriptively to identify common themes related to patient experiences with the intervention. No numerical score will be calculated.	At the discharge from inpatient rehabilitation (6-8 wk post-surgery).

Collaborators and Investigators

• Sponsor: Ludwig Boltzmann Institute for Digital Health and Prevention
• Collaborators: Paracelsus Medical University; Medizinische Zentrum Bad Vigaun GmbH & Co. KG
• Investigators: Study Director: Daniela Wurhofer, Dr., Ludwig Boltzmann Institute for Digital Health and Prevention

Publications and helpful links

General Publications

• Wang L, Lee M, Zhang Z, Moodie J, Cheng D, Martin J. Does preoperative rehabilitation for patients planning to undergo joint replacement surgery improve outcomes? A systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2016 Feb 2;6(2):e009857. doi: 10.1136/bmjopen-2015-009857.
• Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.
• Nguyen C, Boutron I, Roren A, Anract P, Beaudreuil J, Biau D, Boisgard S, Daste C, Durand-Zaleski I, Eschalier B, Gil C, Lefevre-Colau MM, Nizard R, Perrodeau E, Rabetrano H, Richette P, Sanchez K, Zalc J, Coudeyre E, Rannou F. Effect of Prehabilitation Before Total Knee Replacement for Knee Osteoarthritis on Functional Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e221462. doi: 10.1001/jamanetworkopen.2022.1462.
• Adebero T, Omana H, Somerville L, Lanting B, Hunter SW. Effectiveness of prehabilitation on outcomes following total knee and hip arthroplasty for osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. Disabil Rehabil. 2024 Dec;46(24):5771-5790. doi: 10.1080/09638288.2024.2313128. Epub 2024 Feb 13.

Helpful Links

• Project website describing the Prehab2Rehab framework, including prehabilitation and rehabilitation concepts, study objectives, and institutional partners.

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Perioperative Care; Digital Health; Prehabilitation; Exercise Therapy; Tele-rehabilitation; Randomised Controlled Trial; Rehabilitation Pathway
• Additional Relevant MeSH Terms: Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Investigative Techniques; Technology, Pharmaceutical; Exercise; Dosage Forms
• Other Study ID Numbers: Prehab2Rehab-KneeTEP; Nr.1163/2025 (Other Identifier: Ethics Committee of the State of Salzburg)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared in order to protect participant confidentiality and in accordance with applicable data protection regulations, including the General Data Protection Regulation (GDPR). Only aggregated and fully anonymized data will be reported in scientific publications and presentations. No individual-level data will be made publicly available. Access to underlying data may be considered upon reasonable request and subject to institutional, ethical, and legal approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No