Knee OsteoarthritisNCT05094258
Comparison of Early Results of Mobile and Fixed Insert Unicondylar Knee Prosthesis.
A study testing unicondylar knee prosthesis with mobile insert and unicondylar knee prosthesis with fixed insert in people with Knee Osteoarthritis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Comparison of the early clinical and radiological results and patient satisfaction of the mobile and fixed insert unicondylar knee prostheses routinely used in the clinic. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- unicondylar knee prosthesis with mobile insert and unicondylar knee prosthesis with fixed insert
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 1 Nov 2022
- Phase
- Interventional
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with degenerative knee arthritis with only one compartment affected
Who cannot join
- Inflammatory Arthritis
- Tricompartmental arthritis
- Patients with fixed varus deformity greater than -10 degrees
- Patients with fixed valgus deformity greater than -5 degrees
- Patients with knee range of motion less than 90 degrees
- Patients with more than 10 degrees of flexion contracture"
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Volkan Ezici
Istanbul, Fatih, 3344
volkan Ezici, 00905331508025, volkanezicimd@gmail.com
About this study
Official title: Comparison of Early Clinical and Radiological Results and Patient Satisfaction of Mobile and Fixed Insert Unicondylar Knee Prosthesis
Comparison of the early clinical and radiological results and patient satisfaction of the mobile and fixed insert unicondylar knee prostheses routinely used in the clinic.
Read the detailed description
Unicondylar knee prosthesis operation will be performed on patients with unicompartmental knee arthrosis who apply to our clinic. Patients will be randomized to use mobile or fixed inserts. After 1 year of follow-up, SF-36, KOOS and HSS scores will be taken to examine the clinical satisfaction of the patients. In addition, radiological evaluation will be made for the presence of osteolysis at the tibial implant interface between both groups.
- Conditions
- Knee Osteoarthritis
- Being tested
- unicondylar knee prosthesis with mobile insert, unicondylar knee prosthesis with fixed insert
- Keywords
- Unicompartmental Knee osteoarthritis, Unicompartmental Knee prosthesis, Mobile insert, Fixed İnsert
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unicondylar knee prosthesis with mobile insertProcedure or surgery
Patients with unicondylar knee replacement using the mobile insert option
unicondylar knee prosthesis with fixed insertProcedure or surgery
Patients with unicondylar knee replacement using the fixed insert option
| Study group | Role | What they receive |
|---|---|---|
| mobile insert | Active comparator | Unicondylar knee arthroplasty with mobile insert was applied to 30 patients determined by randomization. The patients were followed for 1 year. Receives: Procedure: unicondylar knee prosthesis with mobile insert |
| fixed insert | Active comparator | Unicondylar knee arthroplasty with fixed insert was applied to 30 patients determined by randomization. The patients were followed for 1 year. Receives: Procedure: unicondylar knee prosthesis with fixed insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form Health Survey (SF-36)
SF-36 Score (0-100) to assess patient satisfaction at postoperative 1st year
Measured: 0-1 year
Knee injury and osteoarthritis outcome score (KOOS)
Knee injury and osteoarthritis outcome score (0-100)
Measured: 0-1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Jun 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with medial knee arthrosis will be randomized to receive unicompartmental knee prosthesis using mobile inserts in 30 patients and fixed inserts in 30 patients. Patients will be evaluated after at least 1 year of follow-up
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Sarikas, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094258
- Sponsor's protocol ID
- 61813471876
- Status last verified
- Nov 2021
- First submitted
- 13 Oct 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Clinical and Radiological Results and Patient Satisfaction of Mobile and Fixed Insert Unicondylar Knee Prosthesis
- ClinicalTrials.gov ID
- NCT05094258
- Acronym / sponsor ID
- 61813471876
- Conditions
- Knee Osteoarthritis
- Keywords
- Unicompartmental Knee osteoarthritis, Unicompartmental Knee prosthesis, Mobile insert, Fixed İnsert
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 26 Oct 2021 (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.
Comparison of the early clinical and radiological results and patient satisfaction of the mobile and fixed insert unicondylar knee prostheses routinely used in the clinic.
Detailed description
Unicondylar knee prosthesis operation will be performed on patients with unicompartmental knee arthrosis who apply to our clinic. Patients will be randomized to use mobile or fixed inserts. After 1 year of follow-up, SF-36, KOOS and HSS scores will be taken to examine the clinical satisfaction of the patients. In addition, radiological evaluation will be made for the presence of osteolysis at the tibial implant interface between both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients with medial knee arthrosis will be randomized to receive unicompartmental knee prosthesis using mobile inserts in 30 patients and fixed inserts in 30 patients. Patients will be evaluated after at least 1 year of follow-up
| Arm | Type | Receives |
|---|---|---|
| mobile insert | Active comparator | Procedure: unicondylar knee prosthesis with mobile insertUnicondylar knee arthroplasty with mobile insert was applied to 30 patients determined by randomization. The patients were followed for 1 year. |
| fixed insert | Active comparator | Procedure: unicondylar knee prosthesis with fixed insertUnicondylar knee arthroplasty with fixed insert was applied to 30 patients determined by randomization. The patients were followed for 1 year. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with degenerative knee arthritis with only one compartment affected
Key exclusion criteria (6 listed)
- Inflammatory Arthritis
- Tricompartmental arthritis
- Patients with fixed varus deformity greater than -10 degrees
- Patients with fixed valgus deformity greater than -5 degrees
- Patients with knee range of motion less than 90 degrees
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 |
|---|---|---|
| unicondylar knee prosthesis with mobile insertPatients with unicondylar knee replacement using the mobile insert option | Procedure or surgery | mobile insert |
| unicondylar knee prosthesis with fixed insertPatients with unicondylar knee replacement using the fixed insert option | Procedure or surgery | fixed insert |
Primary outcome
Short Form Health Survey (SF-36)
Time frame: 0-1 year
SF-36 Score (0-100) to assess patient satisfaction at postoperative 1st year
Knee injury and osteoarthritis outcome score (KOOS)
Time frame: 0-1 year
Knee injury and osteoarthritis outcome score (0-100)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: No. Participant data will not be shared
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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?
A study testing unicondylar knee prosthesis with mobile insert and unicondylar knee prosthesis with fixed insert in people with Knee Osteoarthritis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 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 30 Nov 2021. 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 Turkey (Türkiye). 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 Volkan Ezici (00905331508025, volkanezicimd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form Health Survey (SF-36) (time frame: 0-1 year). 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 30 Nov 2021.