Bone Scintigraphy and Knee ArthroplastyPUC-INTEVONCT03145090
Bone Scintigraphy and Unicompartimental Knee Arthroplasty
An observational study of Bone Scintigraphy and Knee Arthroplasty, run by University Hospital, Brest at 2 sites in France.
Trial summary
Study the potential interest of bone scintigraphy for patients undergoing unicompartmental knee arthroplasty Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Scintigraphy and Knee Arthroplasty
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Mar 2017to 11 Oct 2019
- 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: patient over 18 years old undergoing unicompartmental knee arthroplasty (1 or 2 knee) and who accept the study
Who may be able to join
- patient over 18 years old / uni or bilateral unicompartmental knee prothesis/ non opposition
Who cannot join
- Under 18 years old/ contraindications for bone scintigraphy/ refusal to participate
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Interest of Bone Scintigraphy in Pre-operative Assessment of Knee Osteoarthritis in Patients Undergoing Unicompartmental Knee Arthroplasty
Study the potential interest of bone scintigraphy for patients undergoing unicompartmental knee arthroplasty
Read the detailed description
Knee osteoarthritis is a very common disease with significant functional consequences. Surgical treatment is the ultimate treatment with the possibility of replacing only one compartment or the 3 joint compartments.
Consequently, the pre-surgical imaging is essential to ensure that the 3 compartments are not compromised when a uni-compartmental prosthesis (PUC) is considered.
The scintigraphy because of its good diagnostic performance seems to be interesting in this indication for the preoperative assessment of knee uni-compartmental prostheses to ensure the absence of degenerative lesion of the unoperated compartment.
This study will evaluate the impact of bone scintigraphy on surgery and the potential correlation between scintigraphic and clinical data; study the pronostic impact of bone scintigraphy
- Conditions
- Bone Scintigraphy and Knee Arthroplasty
- Keywords
- bone scintigraphy, knee arthroplasty, spect-ct, quantification
What is being measured
The primary outcome is the main question the study is designed to answer.
modification in surgical strategy according to bone scintigraphy results
pourcentage of therapeutic modification according to bone scintigraphy results
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start16 Mar 2017
- Primary completion16 Sep 2017
- Study completion11 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Scintigraphy and Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145090
- Sponsor's protocol ID
- PUC-INTEVO (29BRC17.0027)
- Acronym
- PUC-INTEVO
- Status last verified
- Jul 2018
- First submitted
- 5 May 2017
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Bone Scintigraphy in Pre-operative Assessment of Knee Osteoarthritis in Patients Undergoing Unicompartmental Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03145090
- Acronym / sponsor ID
- PUC-INTEVO / PUC-INTEVO (29BRC17.0027)
- Conditions
- Bone Scintigraphy and Knee Arthroplasty
- Keywords
- bone scintigraphy, knee arthroplasty, spect-ct, quantification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 16 Sep 2017 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 9 May 2017 (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.
Study the potential interest of bone scintigraphy for patients undergoing unicompartmental knee arthroplasty
Detailed description
Knee osteoarthritis is a very common disease with significant functional consequences. Surgical treatment is the ultimate treatment with the possibility of replacing only one compartment or the 3 joint compartments.
Consequently, the pre-surgical imaging is essential to ensure that the 3 compartments are not compromised when a uni-compartmental prosthesis (PUC) is considered.
The scintigraphy because of its good diagnostic performance seems to be interesting in this indication for the preoperative assessment of knee uni-compartmental prostheses to ensure the absence of degenerative lesion of the unoperated compartment.
This study will evaluate the impact of bone scintigraphy on surgery and the potential correlation between scintigraphic and clinical data; study the pronostic impact of bone scintigraphy
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patient over 18 years old undergoing unicompartmental knee arthroplasty (1 or 2 knee) and who accept the study
Key inclusion criteria (1 listed)
- patient over 18 years old / uni or bilateral unicompartmental knee prothesis/ non opposition
Key exclusion criteria (1 listed)
- Under 18 years old/ contraindications for bone scintigraphy/ refusal to participate
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
modification in surgical strategy according to bone scintigraphy results
Time frame: 18 months
pourcentage of therapeutic modification according to bone scintigraphy results
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 12 Aug 2024.
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 Bone Scintigraphy and Knee Arthroplasty, run by University Hospital, Brest at 2 sites in France.
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 1 inclusion and 1 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 12 Aug 2024. 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 France. 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?
modification in surgical strategy according to bone scintigraphy results (time frame: 18 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 12 Aug 2024.