Arthroplasty, Replacement, HipORTHOPATHNCT05182320
Study Measuring the Effects of Patient Data for Total Hip and Total Knee Arthroplasty Patients Using an APP Based Sensor for Home Exercise Performance Before and After Operation
An observational study of Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by Aesculap AG at 2 sites in Germany.
Trial summary
Multicenter, Prospective, Randomized, Comparative Study Measuring the Effects on Clinical Outcomes, Patient Satisfaction, Costs and Benefits of Combined Pre-, Intra- and Postoperative Patient Data for THA and TKA Patients Using an APP Based Sensor for Home Exercise Performance Before and After Operation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Clinical Outcome
- What is being tested?
- OrthoPath
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jun 2023to 1 Jun 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients undergoing primary unilateral Total Knee and Hip Arthroplasty
Who may be able to join
- Primary, unilateral total knee and hip replacement patients
- Participant is min. 18 years of age
- Participant is able and willing to provide written informed consent
- Participant with ability to work with smart devices
- Participant having its own device (Apple iPhone or iPad with latest iOS version or Android tablet or smart phone min. Android version 6) and are able to handle the app and/or sensor
Who cannot join
- Pregnancy
- Participant has mental in capabilities - unable to give informed consent
- Participants who are unwilling or mentally and/or physically unable to adhere to study procedures
- Participant is having orthopaedic co-morbidities such as: previous HTO at indexed joint or prior UKA
- Flexion contracture > 15°
- Varus/valgus deformity > 10°
- Participant is having dementia or other cognitive impairment
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
RHÖN-KLINIKUM Campus Bad Neustadt
Bad Neustadt an der Saale, 97616
Sportklinik Ravensburg GmbH & Co. KG
Ravensburg, Baden-Wurttemberg, 88214
About this study
Official title: Multicenter, Prospective, Randomized, Comparative Study Measuring the Effects on Clinical Outcomes, Patient Satisfaction, Costs and Benefits of Combined Pre-, Intra- and Postoperative Patient Data for THA and TKA Patients Using an APP Based Sensor for Exercise Performance Before and After Operation
Multicenter, Prospective, Randomized, Comparative Study Measuring the Effects on Clinical Outcomes, Patient Satisfaction, Costs and Benefits of Combined Pre-, Intra- and Postoperative Patient Data for THA and TKA Patients Using an APP Based Sensor for Home Exercise Performance Before and After Operation
- Conditions
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Clinical Outcome, Patient Satisfaction, Treatment Cost
- Being tested
- OrthoPath, Control
- Keywords
- randomized comparative study, clinical outcome, App based sensor, Home Exercise
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthoPathDevice
unilateral TKA and THA patients using the BPMpathway rehabilitation sensor system
ControlDevice
unilateral TKA and THA patients not using the BPMpathway rehabilitation sensor system
| Study group | Role | What they receive |
|---|---|---|
| OrthoPath | Not described Receives: Device: OrthoPath | |
| Control | Not described Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoarthritis Outcome Score
The Patient self-assessed Injury and Osteoarthritis Outcome Scores for Knee (KOOS) and hip (HOOS) are joint-specific instruments:
The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).
The HOOS evaluates both short-term and long-term consequences of hip injury. It holds 5 separate patient-relevant dimensions: Pain (P), Symptoms (S), Activity limitations daily living (ADL), Function in sport and recreation (SP) and hip related quality of life (QOL).
Both scores are percentage scores from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: 12 weeks after surgery
Secondary outcomes (9)
Patient satisfaction
Based on a single question patients are asked to grade their level of satisfaction with the methodology and rehabilitation procedure. Patients can choose between "very dissatisfied", "dissatisfied", "satisfied" or "very satisfied". The grades may be summarized as "satisfied" vs. "dissatisfied".
Measured: 12 weeks after surgery
Patient User Experience
A measurement just for the patients of the study group. The user feedback is collected at the endpoint
Measured: at final follow-up approx. 7 months after surgery
Patient compliance
A measurement just for the patients of the study group. Data collection (Counting) how often patients use BPMpathway before and after operation to determine compliance with specification of using BPMpathway three times per day every day through data analytics
Measured: at final follow-up approx. 7 months after surgery
Economical [time and costs]
Comparing conventional rehabilitation methods and tele-rehabilitation under cost aspects enlarged by quality aspects such as acceptance and satisfaction degree of the patient
Measured: 12 weeks after surgery
Course of Active Range of Motion
Study Group: Measured with BPMpathway sensor and app 3 times per day for the entire duration and measures with manual goniometer during all clinical visits (in 5° steps) Control Group: Measured with manual goniometer during all clinical visits (in 5°steps)
Measured: repeatedly from pre-op consultation until final follow-up approx. 7 months after surgery
Development of Pain
Study Group: Pain measured within BPMpathway app 3 times per day for the entire duration by Wong Baker Pain Score until post-operative follow-up meeting and during all clinical visits Control Group: Pain measured with Wong Baker Pain Scale during all clinical visits
The Wong-Baker proves to be an inexpensive, yet easy to use, pain scale. The scale consists of six faces that range from no pain at all to the worst pain imaginable. The emotional faces range from smiling to grimacing.
Measured: repeatedly through study completion, an average of 7 months postoperatively.
Fatigue
Study Group and Control Group: Measures with Fatigue Severity Scale. The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. It was originally devised for people with Multiple Sclerosis or systemic lupus erythematosus.
The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree; the minimum score is 9 and the maximum score is 63. The higher the score the greater the fatigue severity.
Measured: at pre-operative consultation, post-operative consultation (12 weeks) and 6 months after surgery
Radiographic Analysis
Unless limited by patient or equipment constraints, all follow-up imaging exams will be obtained. Imaging will be used to evaluate the implant status as well as device condition and potential presence of device-related Adverse Events including fracture, wear, loosening or radiolucencies. X-rays are taken according to the radiographic protocol of the hospital and the set routine
Measured: through study completion, an average of 7 months postoperatively
Number of (Serious) Adverse Events
During the course of the study, any upcoming intra- or postoperative (serious) adverse device events or effects related or not related to the product under investigation, will be documented in the dedicated Case Report Forms. The total number of AEs will be summarized and further evaluated by the sponsor and reported according to local legislation and necessity. Recorded complications will be categorized and analyzed in order to assess the safety of the investigational product
Measured: through study completion, an average of 7 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Jun 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Why it stopped: contracts were not closed in time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182320
- Sponsor's protocol ID
- AAG-O-H-2108
- Acronym
- ORTHOPATH
- Status last verified
- Aug 2023
- First submitted
- 1 Dec 2021
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Randomized, Comparative Study Measuring the Effects on Clinical Outcomes, Patient Satisfaction, Costs and Benefits of Combined Pre-, Intra- and Postoperative Patient Data for THA and TKA Patients Using an APP Based Sensor for Exercise Performance Before and After Operation
- ClinicalTrials.gov ID
- NCT05182320
- Acronym / sponsor ID
- ORTHOPATH / AAG-O-H-2108
- Conditions
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Clinical Outcome, Patient Satisfaction, Treatment Cost
- Keywords
- randomized comparative study, clinical outcome, App based sensor, Home Exercise
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: contracts were not closed in time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 10 Jan 2022 (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.
Multicenter, Prospective, Randomized, Comparative Study Measuring the Effects on Clinical Outcomes, Patient Satisfaction, Costs and Benefits of Combined Pre-, Intra- and Postoperative Patient Data for THA and TKA Patients Using an APP Based Sensor for Home Exercise Performance Before and After Operation
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OrthoPath | – | Device: OrthoPath |
| Control | – | Device: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary unilateral Total Knee and Hip Arthroplasty
Key inclusion criteria (5 listed)
- Primary, unilateral total knee and hip replacement patients
- Participant is min. 18 years of age
- Participant is able and willing to provide written informed consent
- Participant with ability to work with smart devices
- Participant having its own device (Apple iPhone or iPad with latest iOS version or Android tablet or smart phone min. Android version 6) and are able to handle the app and/or sensor
Key exclusion criteria (7 listed)
- Pregnancy
- Participant has mental in capabilities - unable to give informed consent
- Participants who are unwilling or mentally and/or physically unable to adhere to study procedures
- Participant is having orthopaedic co-morbidities such as: previous HTO at indexed joint or prior UKA
- Flexion contracture > 15°
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 |
|---|---|---|
| OrthoPathunilateral TKA and THA patients using the BPMpathway rehabilitation sensor system | Device | OrthoPath |
| Controlunilateral TKA and THA patients not using the BPMpathway rehabilitation sensor system | Device | Control |
Primary outcome
Osteoarthritis Outcome Score
Time frame: 12 weeks after surgery
The Patient self-assessed Injury and Osteoarthritis Outcome Scores for Knee (KOOS) and hip (HOOS) are joint-specific instruments: The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The HOOS evaluates both short-term and long-term consequences of hip injury. It holds 5 separate patient-relevant dimensions: Pain (P), Symptoms (S), Activity limitations daily living (ADL), Function in sport and recreation (SP) and hip related quality of life (QOL). Both scores are percentage scores from 0 to 100, 0 representing extreme problems and 100 representing no problems.
9 secondary outcomes
Patient satisfaction
Time frame: 12 weeks after surgery
Patient User Experience
Time frame: at final follow-up approx. 7 months after surgery
Patient compliance
Time frame: at final follow-up approx. 7 months after surgery
Economical [time and costs]
Time frame: 12 weeks after surgery
Course of Active Range of Motion
Time frame: repeatedly from pre-op consultation until final follow-up approx. 7 months after surgery
Development of Pain
Time frame: repeatedly through study completion, an average of 7 months postoperatively.
Fatigue
Time frame: at pre-operative consultation, post-operative consultation (12 weeks) and 6 months after surgery
Radiographic Analysis
Time frame: through study completion, an average of 7 months postoperatively
Number of (Serious) Adverse Events
Time frame: through study completion, an average of 7 months postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by Aesculap AG at 2 sites in Germany.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 was withdrawn before enrolling participants, so there are no results.
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?
Osteoarthritis Outcome Score (time frame: 12 weeks after surgery). 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 25 Aug 2023.