Knee ReplacementInORNCT04167787
Intelligent Operating Room (InOR) for Orthopaedic Surgery
An observational study of Knee Replacement and Musculoskeletal, run by Digital Surgery Ltd. at 1 site in United Kingdom.
Trial summary
The objective of the study is to evaluate the usefulness of digital technologies to support surgical teams before, during, and after an operation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Knee Replacement, Musculoskeletal
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Oct 2019to 2 Dec 2020
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: -Adult patients undergoing elective total and unicondylar knee replacement.
Who may be able to join
- Adult patients 18-99 years.
- All willing patients undergoing elective total and unicondylar knee replacement (both navigated and robotic-assisted).
Who cannot join
- Patients/staff who are unwilling to participate in the study
- Patients/staff that withdraw from the study
- Two stage revisions for infected primary total knee replacements, multiple stage procedures for complex deformities,
- Single stage revision procedures with the need for special instruments and modified steps
- Patients with cognitive impairment/ special cognitive needs.
- <18 years old
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital NHS Trust
London, NW1 2BU
Nachappa Sivanesan Uthraraj, nachappa.uthraraj@nhs.net
About this study
The objective of the study is to evaluate the usefulness of digital technologies to support surgical teams before, during, and after an operation.
- Conditions
- Knee Replacement, Musculoskeletal
- Keywords
- Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline scores of qualitative questionnaires (every 8 weeks in one surgical team).
To determine how digital technologies and advanced data analytics can improve team coordination, efficiency and performance intraoperatively through understanding and mapping of surgical workflows and instrumentation use.
Measured: 14 months
Secondary outcomes (2)
Report the effect of presenting information intraoperatively through digital displays and augmented reality headsets.
Assessed through monitoring scores from qualitative questionnaires of the surgical team;
Measured: 14 months
To provide automatic post-operative analytics after each surgical operation (up to 150 cases).
Including phase timings and instrumentation
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start10 Oct 2019
- Primary completion2 Dec 2020 (estimated)
- Study completion2 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Digital Surgery Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167787
- Sponsor's protocol ID
- ULCH DS 001
- Acronym
- InOR
- Status last verified
- Nov 2019
- First submitted
- 18 Oct 2019
- Last updated
- 20 Nov 2019
- 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 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Operating Room (InOR) for Orthopaedic Surgery
- ClinicalTrials.gov ID
- NCT04167787
- Acronym / sponsor ID
- InOR / ULCH DS 001
- Conditions
- Knee Replacement, Musculoskeletal
- Keywords
- Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Digital Surgery Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University College London Hospitals
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 2 Dec 2020 (estimated)
- Study completion
- 2 Dec 2020 (estimated)
- First posted
- 19 Nov 2019 (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 objective of the study is to evaluate the usefulness of digital technologies to support surgical teams before, during, and after an operation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- -Adult patients undergoing elective total and unicondylar knee replacement.
Key inclusion criteria (2 listed)
- Adult patients 18-99 years.
- All willing patients undergoing elective total and unicondylar knee replacement (both navigated and robotic-assisted).
Key exclusion criteria (6 listed)
- Patients/staff who are unwilling to participate in the study
- Patients/staff that withdraw from the study
- Two stage revisions for infected primary total knee replacements, multiple stage procedures for complex deformities,
- Single stage revision procedures with the need for special instruments and modified steps
- Patients with cognitive impairment/ special cognitive needs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in baseline scores of qualitative questionnaires (every 8 weeks in one surgical team).
Time frame: 14 months
To determine how digital technologies and advanced data analytics can improve team coordination, efficiency and performance intraoperatively through understanding and mapping of surgical workflows and instrumentation use.
2 secondary outcomes
Report the effect of presenting information intraoperatively through digital displays and augmented reality headsets.
Time frame: 14 months
To provide automatic post-operative analytics after each surgical operation (up to 150 cases).
Time frame: 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Replacement and Musculoskeletal, run by Digital Surgery Ltd. at 1 site in United Kingdom.
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 6 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: status not confirmed, as of the sponsor's last update on 20 Nov 2019. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Kerr, Dr (07967135052, karen.kerr@touchsurgery.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline scores of qualitative questionnaires (every 8 weeks in one surgical team). (time frame: 14 months). 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 20 Nov 2019.