Total Hip ReplacementNCT07120191
An Open Label Data Collection Study of My Connect Post-Op, a Post-Operative Communication Tool
An observational study of Total Hip Replacement and Total Knee Replacement, run by Concentra AI, inc at 3 sites in United States.
Trial summary
This open label, multi-center study will collect data from the participant's use of My Connect Post-Op Software as a post-operative communication solution in supporting patient recovery through Technology-Assisted Conversation (TAC). Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Total Hip Replacement, Total Knee Replacement
- What is being tested?
- post op communication software
- Type of treatment
- Medical device
- How many people
- 652 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2025to 30 Jul 2026
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: community sample from orthopedic practices
Who may be able to join
- Orthopedic patients scheduled for elective joint arthroplasty (single or double knee, or single or double hip replacement surgery).
- Age 22-80 years. Owns a smart phone. Speaks and understands written and spoken English. Ability to give written informed consent.
Who cannot join
- Known diagnosis of a psychiatric disorder. Known opioid dependence in the Investigator's opinion that may complicate participation.
- Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding trial inclusion and throughout the duration of the trial.
- Any condition that in the Investigator's opinion may complicate or preclude the subject from participating in this trial, such as physical impairment or noncooperation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mercy Medical Center
Baltimore, Maryland, 21202
OrthoAZ
Phoenix, Arizona, 85018
Kansas Joint and Spine
Wichita, Kansas, 67226
About this study
This open label, multi-center study will collect data from the participant's use of My Connect Post-Op Software as a post-operative communication solution in supporting patient recovery through Technology-Assisted Conversation (TAC). The application will be tested by patients who have undergone total joint replacement as a post-op communication tool. Data will be collected on how effectively the product guides patients through their recovery, identifying potential complications, and providing appropriate recommendations based on structured question pairs.
Read the detailed description
Patients who are scheduled to undergo orthopedic total hip or total knee replacement surgery who meet the eligibility criteria will be enrolled in the study. Prior to surgery, participants will be trained on the use of the product and study requirements will be discussed. The training provides instructions at an in-office visit, outlining the device's usage. The instructions, along with warnings that the interface is with a computer and not a person, are emphasized in the device's app and user manual.
Daily prompts will interact with the patient, and the app will answer questions and direct specialized care/instructions. Participants will be instructed to engage with the software throughout the 30-day study period, responding to prompts and questions as the participant recovers from surgery. The software will log and archive all participants' interactions with the chatbot in the backend. Participants will be expected to utilize the investigational product after discharge and complete the 30-day study period.
For every active participant enrolled, a retrospective chart review patient from the same site will be enrolled in the study in a 1:1 manner. The retrospective review of approximately 200 patient's post-op clinical interactions will be collected as a control group for comparison.
An initial technical assessment of the application will be done with the first 10 active patients who have used the product for at least 2 weeks, focusing on the overall performance of the communication tool.
The primary objective of the study is to collect a structured conversation log, document product's decision-making patterns, and to ensure sufficient coverage of clinical scenarios.
Beyond the AI-driven conversation, the product will collect daily health characteristics on pain, sleep, activity levels, medication use, and diet. Pain reporting is captured through two distinct input methods: the GRASP® device, a trademarked handheld event marker used to record three distinct pain levels, and a smartphone-based slider, allowing for subjective pain self-reporting. The participant may choose either input method, both will be encouraged.
Additional product components include chat functionality and the provider dashboard.
Chat function will collect data for responsiveness, clarity, and patient engagement, ensuring it facilitates a smooth and intuitive post-operative communication experience. The provider dashboard will collect usability and functionality data, as it mirrors the patient's application while also allowing providers to manage office setup, input new patients, confirm surgical dates, and conduct real-time chat interactions with patients.
Both patient and provider satisfaction of the use of My Connect Post-Op Software will be collected periodically throughout the 30-day post-op period as noted in the Schedule of Activities.
- Conditions
- Total Hip Replacement, Total Knee Replacement
- Being tested
- post op communication software
- Keywords
- Total joint replacement, post op communication, AI assisted conversation, artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post op communication softwareDevice
Also called MyConnect Post Op
MyConnect Post Op is a communication tool that utilizes Technology Assisted Conversation to aid in the recovery of total knee and hip replacement patients
| Study group | Role | What they receive |
|---|---|---|
| Adults undergoing total hip or knee replacement surgery | The entire active group will be utilizing the MyConnect Post Op communication tool. Receives: Device: post op communication software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect structured conversation logs
Collect conversations between the participant and the clinically conversant AI
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 May 2025
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concentra AI, inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120191
- Sponsor's protocol ID
- CCAI-PostOp-2025-001
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Data Collection Study of My Connect Post-Op, a Post-Operative Communication Tool
- ClinicalTrials.gov ID
- NCT07120191
- Acronym / sponsor ID
- CCAI-PostOp-2025-001
- Conditions
- Total Hip Replacement, Total Knee Replacement
- Keywords
- Total joint replacement, post op communication, AI assisted conversation, artificial intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- Concentra AI, incIndustry (pharma, biotech, devices)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 13 Aug 2025 (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 open label, multi-center study will collect data from the participant's use of My Connect Post-Op Software as a post-operative communication solution in supporting patient recovery through Technology-Assisted Conversation (TAC). The application will be tested by patients who have undergone total joint replacement as a post-op communication tool. Data will be collected on how effectively the product guides patients through their recovery, identifying potential complications, and providing appropriate recommendations based on structured question pairs.
Detailed description
Patients who are scheduled to undergo orthopedic total hip or total knee replacement surgery who meet the eligibility criteria will be enrolled in the study. Prior to surgery, participants will be trained on the use of the product and study requirements will be discussed. The training provides instructions at an in-office visit, outlining the device's usage. The instructions, along with warnings that the interface is with a computer and not a person, are emphasized in the device's app and user manual.
Daily prompts will interact with the patient, and the app will answer questions and direct specialized care/instructions. Participants will be instructed to engage with the software throughout the 30-day study period, responding to prompts and questions as the participant recovers from surgery. The software will log and archive all participants' interactions with the chatbot in the backend. Participants will be expected to utilize the investigational product after discharge and complete the 30-day study period.
For every active participant enrolled, a retrospective chart review patient from the same site will be enrolled in the study in a 1:1 manner. The retrospective review of approximately 200 patient's post-op clinical interactions will be collected as a control group for comparison.
An initial technical assessment of the application will be done with the first 10 active patients who have used the product for at least 2 weeks, focusing on the overall performance of the communication tool.
The primary objective of the study is to collect a structured conversation log, document product's decision-making patterns, and to ensure sufficient coverage of clinical scenarios.
Beyond the AI-driven conversation, the product will collect daily health characteristics on pain, sleep, activity levels, medication use, and diet. Pain reporting is captured through two distinct input methods: the GRASP® device, a trademarked handheld event marker used to record three distinct pain levels, and a smartphone-based slider, allowing for subjective pain self-reporting. The participant may choose either input method, both will be encouraged.
Additional product components include chat functionality and the provider dashboard.
Chat function will collect data for responsiveness, clarity, and patient engagement, ensuring it facilitates a smooth and intuitive post-operative communication experience. The provider dashboard will collect usability and functionality data, as it mirrors the patient's application while also allowing providers to manage office setup, input new patients, confirm surgical dates, and conduct real-time chat interactions with patients.
Both patient and provider satisfaction of the use of My Connect Post-Op Software will be collected periodically throughout the 30-day post-op period as noted in the Schedule of Activities.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults undergoing total hip or knee replacement surgery | – | Device: post op communication softwareThe entire active group will be utilizing the MyConnect Post Op communication tool. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community sample from orthopedic practices
Key inclusion criteria (2 listed)
- Orthopedic patients scheduled for elective joint arthroplasty (single or double knee, or single or double hip replacement surgery).
- Age 22-80 years. Owns a smart phone. Speaks and understands written and spoken English. Ability to give written informed consent.
Key exclusion criteria (3 listed)
- Known diagnosis of a psychiatric disorder. Known opioid dependence in the Investigator's opinion that may complicate participation.
- Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding trial inclusion and throughout the duration of the trial.
- Any condition that in the Investigator's opinion may complicate or preclude the subject from participating in this trial, such as physical impairment or noncooperation
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 |
|---|---|---|
| post op communication softwareAlso: MyConnect Post OpMyConnect Post Op is a communication tool that utilizes Technology Assisted Conversation to aid in the recovery of total knee and hip replacement patients | Device | Adults undergoing total hip or knee replacement surgery |
Primary outcome
Collect structured conversation logs
Time frame: From enrollment to the end of treatment at 4 weeks
Collect conversations between the participant and the clinically conversant AI
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 31 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Replacement and Total Knee Replacement, run by Concentra AI, inc at 3 sites in United States.
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 2 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 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Collect structured conversation logs (time frame: From enrollment to the end of treatment at 4 weeks). 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 31 Aug 2026.