Arthritis KneeNCT06433700
Risk of Revision Following Knee Arthroplasty in Bariatric Surgery Patients
An observational study of Arthritis Knee and Bariatric Surgery Candidate, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Previous studies have investigated the outcomes of Knee Arthroplasty (KA) following Bariatric Surgery (BAS), but with substantial limitations as not stratifying for Body Mass Index (BMI) at time of KA or not addressing the type of BAS (gastric bypass, banding or sleeve). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis Knee, Bariatric Surgery Candidate, Prosthesis Failure
- What is being tested?
- BAS and Non-BAS
- How many people
- 99,965 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2024to 1 Feb 2025
- How long will I take part?
- 2 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The investigators will include patients with primary/idiopathic or secondary (due to meniscus or cruciate ligament lesion) osteoarthritis (OA) who received primary KA in the period from 2011 and 2 years earlier to data-extraction date. Patients will be identified from the DKR. Patients are followed for 2 years, until first revision, death or migration, whichever comes first.
Who may be able to join
- Primary knee arthroplasty due to osteoarthritis
Who cannot join
- Primary knee arthroplasty due to traumatic osteoarthritis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk of Revision and Other Complications Following Knee Arthroplasty in Patients Previously Exposed to Bariatric Surgeries: A Nationwide, Register-based Study
Previous studies have investigated the outcomes of Knee Arthroplasty (KA) following Bariatric Surgery (BAS), but with substantial limitations as not stratifying for Body Mass Index (BMI) at time of KA or not addressing the type of BAS (gastric bypass, banding or sleeve). Since BMI varies greatly in patients with previous BAS, it is likely that BMI affects outcomes after KA in BAS-operated patients.
The investigators believe that stratifying for BMI would explain the contradictions with the previous research in this patient group when it comes to the risk of revision after KA.
- Conditions
- Arthritis Knee, Bariatric Surgery Candidate, Prosthesis Failure, Prosthesis Survival, Prosthesis-Related Infections
- Being tested
- BAS, Non-BAS
- Keywords
- arthroplasty, revision, bariatric
- Medical subject headings
- Prosthesis Failure, Prosthesis-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASOther
NOMESCO (Nordic Medico-Statistical Committee) Classification of Surgical Procedures (KJDF10 \& KJDF11 [gastric bypass]; KJDF20 \& KJDF21 [gastric banding]; KJDF40, KJDF41, KJDF96 \& KJDF97 [gastric sleeve]).
Non-BASOther
Patients without BAS codes
| Study group | Role | What they receive |
|---|---|---|
| BAS group | Patients who received bariatric surgery prior to their knee arthroplasty Receives: Other: BAS | |
| Non-BAS group | Patients who did not receive bariatric surgery prior to their knee arthroplasty Receives: Other: Non-BAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazard rate of Revision due to any cause
Revision surgery is defined as surgery with debridement and/or exchange of at least one component
Measured: within 90 days and within 2 years
Hazard rate of Revision due to infection
Our definition of infection is adapted from the European Bone and Joint Infection Society (EBJIS) criteria as at least one of the following A. An indication of deep infection is reported to the Danish knee arthroplasty register (DKR) by the surgeon on revision surgery B. At least 2 deep-tissue samples of phenotypically indistinguishable bacteria isolated from at least 3 deep-tissue samples C. One or more positive intraoperative samples from a closed fluid aspirate AND a biopsy (fluid AND tissue) of phenotypically indistinguishable bacteria isolated.
Measured: within 90 days and within 2 years
Secondary outcomes (3)
Hazard rate of Knee related antibiotic use within 30- and 90-days following KA
the use of one of the following oral antibiotics: dicloxacillin, flucloxacillin, phenoxymethylpenicillin, amoxicillin, oral ciprofloxacin, roxithromycin, linezolid, cefuroxime and cefalexin
Measured: within 30- and 90-days following KA
Hazard rate of Antibiotic use due to other causes
the use of one of oral antibiotics other than those that were mentioned in outcome 3.
Measured: within 30- and 90-days following KA
Mortality
Mortality registered in the Danish Civil Registration System (DCRS) by date
Measured: 2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jun 2024
- Primary completion2 Dec 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis KneeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99,965 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saber Muthanna Saber, Bispebjerg Hospital
- Investigators
- Søren Overgaard, MD,DMSc,Prof, Study director, Department of orthopedic surgery, Bispebjerg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433700
- Sponsor's protocol ID
- p-2023-14433
- Status last verified
- Feb 2026
- First submitted
- 7 Sep 2023
- Last updated
- 27 Feb 2026
- Results posted
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Revision and Other Complications Following Knee Arthroplasty in Patients Previously Exposed to Bariatric Surgeries: A Nationwide, Register-based Study
- ClinicalTrials.gov ID
- NCT06433700
- Acronym / sponsor ID
- p-2023-14433
- Conditions
- Arthritis Knee, Bariatric Surgery Candidate, Prosthesis Failure, Prosthesis Survival, Prosthesis-Related Infections
- Keywords
- arthroplasty, revision, bariatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99,965 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 30 May 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.
Previous studies have investigated the outcomes of Knee Arthroplasty (KA) following Bariatric Surgery (BAS), but with substantial limitations as not stratifying for Body Mass Index (BMI) at time of KA or not addressing the type of BAS (gastric bypass, banding or sleeve). Since BMI varies greatly in patients with previous BAS, it is likely that BMI affects outcomes after KA in BAS-operated patients.
The investigators believe that stratifying for BMI would explain the contradictions with the previous research in this patient group when it comes to the risk of revision after KA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAS group | – | Other: BASPatients who received bariatric surgery prior to their knee arthroplasty |
| Non-BAS group | – | Other: Non-BASPatients who did not receive bariatric surgery prior to their knee arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will include patients with primary/idiopathic or secondary (due to meniscus or cruciate ligament lesion) osteoarthritis (OA) who received primary KA in the period from 2011 and 2 years earlier to data-extraction date. Patients will be identified from the DKR. Patients are followed for 2 years, until first revision, death or migration, whichever comes first.
Key inclusion criteria (1 listed)
- Primary knee arthroplasty due to osteoarthritis
Key exclusion criteria (1 listed)
- Primary knee arthroplasty due to traumatic osteoarthritis.
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 |
|---|---|---|
| BASNOMESCO (Nordic Medico-Statistical Committee) Classification of Surgical Procedures (KJDF10 \& KJDF11 [gastric bypass]; KJDF20 \& KJDF21 [gastric banding]; KJDF40, KJDF41, KJDF96 \& KJDF97 [gastric sleeve]). | Other | BAS group |
| Non-BASPatients without BAS codes | Other | Non-BAS group |
Primary outcome
Hazard rate of Revision due to any cause
Time frame: within 90 days and within 2 years
Revision surgery is defined as surgery with debridement and/or exchange of at least one component
Hazard rate of Revision due to infection
Time frame: within 90 days and within 2 years
Our definition of infection is adapted from the European Bone and Joint Infection Society (EBJIS) criteria as at least one of the following A. An indication of deep infection is reported to the Danish knee arthroplasty register (DKR) by the surgeon on revision surgery B. At least 2 deep-tissue samples of phenotypically indistinguishable bacteria isolated from at least 3 deep-tissue samples C. One or more positive intraoperative samples from a closed fluid aspirate AND a biopsy (fluid AND tissue) of phenotypically indistinguishable bacteria isolated.
3 secondary outcomes
Hazard rate of Knee related antibiotic use within 30- and 90-days following KA
Time frame: within 30- and 90-days following KA
Hazard rate of Antibiotic use due to other causes
Time frame: within 30- and 90-days following KA
Mortality
Time frame: 2 years postoperatively
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 27 Feb 2026.
- 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.
Søren Overgaard, MD,DMSc,Prof study director
Department of orthopedic surgery, Bispebjerg University Hospital, Denmark
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 Arthritis Knee and Bariatric Surgery Candidate, run by Bispebjerg Hospital at 1 site in Denmark.
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 27 Feb 2026. 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 Denmark. 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?
Hazard rate of Revision due to any cause (time frame: within 90 days and within 2 years). The study lists 2 primary outcomes in all. 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 27 Feb 2026.