Knee ArthritisArOsNCT06559592
Internal Unicompartmental Arthroplasty After Tibial Valgization Osteotomy
An observational study of Knee Arthritis, run by University Hospital, Brest at 1 site in France.
Trial summary
This retrospective, monocentric study is about outcomes concerning patients who benefit from medial unicompartmental knee arthroplasty after previous high tibial osteotomy. This previous high tibial osteotomy was performed because of genu varum. Clinical, funtionnal and radiological outcomes were examined. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Arthritis
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 5 Aug 2021to 2 Nov 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients aged of at least18 years old, who benefit from medial unicompartmental knee arthroplasty after previous high tibial osteotomy. The high tibial osteotomy was made because of genu varum.
Who may be able to join
- operated between January 2005 and June 2019
- HTO followed by implantation of medial UKA (Oxford Partial Knee, Zimmer Biomet, Bridgend, UK) in the same knee
- medial knee osteoarthritis with healthy lateral compartment
- patellofemoral pain
- coronal plane deformity of less than 15°
Who cannot join
- death
- lost to follow-up
- medial UKA implant other than the Oxford Partial Knee
Trial locations and contacts
1 site in 1 country.
About this study
This retrospective, monocentric study is about outcomes concerning patients who benefit from medial unicompartmental knee arthroplasty after previous high tibial osteotomy. This previous high tibial osteotomy was performed because of genu varum.
Clinical, funtionnal and radiological outcomes were examined.
- Conditions
- Knee Arthritis
- Keywords
- orthopedic surgery, unicompartmental knee arthroplasty, high tibial osteotomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Give the functional results using the Oxford score, for patients who underwent this procedure.
Oxford Knee Scale (OKS) score results after a mean follow-up of 79 months after unicompartmental internal arthroplasty, and a mean follow-up of 185 months after tibial valgization osteotomy
Measured: from 4 to 185 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start5 Aug 2021
- Primary completion29 Sep 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthritisStudies 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
- 38 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
- NCT06559592
- Sponsor's protocol ID
- ArOs (29BRC21.0209)
- Acronym
- ArOs
- Status last verified
- May 2022
- First submitted
- 4 Aug 2022
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Unicompartmental Arthroplasty After Tibial Valgization Osteotomy
- ClinicalTrials.gov ID
- NCT06559592
- Acronym / sponsor ID
- ArOs / ArOs (29BRC21.0209)
- Conditions
- Knee Arthritis
- Keywords
- orthopedic surgery, unicompartmental knee arthroplasty, high tibial osteotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 19 Aug 2024 (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 retrospective, monocentric study is about outcomes concerning patients who benefit from medial unicompartmental knee arthroplasty after previous high tibial osteotomy. This previous high tibial osteotomy was performed because of genu varum.
Clinical, funtionnal and radiological outcomes were examined.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients aged of at least18 years old, who benefit from medial unicompartmental knee arthroplasty after previous high tibial osteotomy. The high tibial osteotomy was made because of genu varum.
Key inclusion criteria (5 listed)
- operated between January 2005 and June 2019
- HTO followed by implantation of medial UKA (Oxford Partial Knee, Zimmer Biomet, Bridgend, UK) in the same knee
- medial knee osteoarthritis with healthy lateral compartment
- patellofemoral pain
- coronal plane deformity of less than 15°
Key exclusion criteria (3 listed)
- death
- lost to follow-up
- medial UKA implant other than the Oxford Partial Knee
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
Give the functional results using the Oxford score, for patients who underwent this procedure.
Time frame: from 4 to 185 months
Oxford Knee Scale (OKS) score results after a mean follow-up of 79 months after unicompartmental internal arthroplasty, and a mean follow-up of 185 months after tibial valgization osteotomy
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 19 Aug 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
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 Arthritis, run by University Hospital, Brest at 1 site 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 5 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 19 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 1 site 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?
Give the functional results using the Oxford score, for patients who underwent this procedure. (time frame: from 4 to 185 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 19 Aug 2024.