Unicompartmental Knee ArthroplastyNCT03201172
Univation® X Follow-Up Study
An observational study of Unicompartmental Knee Arthroplasty, run by Aesculap AG at 1 site in Germany.
Trial summary
The study is designed as a monocentric, prospective, observational, comparative follow-up study based on two previously treated patient groups. The first group consists of patients treated with the patient-specific unicondylar knee implant iUni®. For that group, 30 patients will be included in the study and analyzed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unicompartmental Knee Arthroplasty
- What is being tested?
- Primary Unicompartmental Knee Arthroplasty
- Type of treatment
- Medical device
- How many people
- 77 participants
- Where
- 1 siteGermany
- Study dates
- 25 Sep 2017to 1 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- Patients who underwent UKA in 2015/2016 (using one of the products under investigation)
- Signed informed consent
Who cannot join
- pregnancy
- patients < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational 2 Year Follow-up on a Retrospective Cohort of Primary Unicompartmental Knee Arthroplasty (UKA) Patients Treated With Univation® X or iUni®.
The study is designed as a monocentric, prospective, observational, comparative follow-up study based on two previously treated patient groups. The first group consists of patients treated with the patient-specific unicondylar knee implant iUni®. For that group, 30 patients will be included in the study and analyzed. The final follow-up after 24 months has already been documented by the study center. Compared to that, a consecutive series of 50 Univation® X patients will be invited for a 24 months follow-up in 2018. In total, it is planned to include 80 retrospective patients for that historical control study design.
The products under investigation were used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).
- Conditions
- Unicompartmental Knee Arthroplasty
- Being tested
- Primary Unicompartmental Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Unicompartmental Knee ArthroplastyDevice
Primary implantation of an unicompartmental knee implant
| Study group | Role | What they receive |
|---|---|---|
| Univation® X | Not described Receives: Device: Primary Unicompartmental Knee Arthroplasty | |
| iUni® | Not described Receives: Device: Primary Unicompartmental Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee joint function
Knee Society Score
Measured: 2 years after primary implantation
Secondary outcomes (4)
KOOS
Knee Injury and Osteoarthritis Outcome Score
Measured: 2 years after primary implantation
axis justice position
radiological analysis
Measured: preoperative and until discharge from hospital (within 1 week postoperatively)
radiolucent lines
radiological analysis
Measured: 2 years after primary implantation
tibial slope
radiological analysis
Measured: 2 years after primary implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start25 Sep 2017
- Primary completion30 Sep 2019
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unicompartmental Knee ArthroplastyStudies 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
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201172
- Sponsor's protocol ID
- AAG-O-H-1641
- Status last verified
- Apr 2021
- First submitted
- 23 May 2017
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haaker R, Moussa A, Sabev D. No advantage for patient-specific UKA in comparison with standard UKA regarding clinical and functional results at short-term follow-up. Eur J Orthop Surg Traumatol. 2025 Aug 27;35(1):362. doi: 10.1007/s00590-025-04467-2.
PubMed 40866508
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational 2 Year Follow-up on a Retrospective Cohort of Primary Unicompartmental Knee Arthroplasty (UKA) Patients Treated With Univation® X or iUni®.
- ClinicalTrials.gov ID
- NCT03201172
- Acronym / sponsor ID
- AAG-O-H-1641
- Conditions
- Unicompartmental Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 28 Jun 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.
The study is designed as a monocentric, prospective, observational, comparative follow-up study based on two previously treated patient groups. The first group consists of patients treated with the patient-specific unicondylar knee implant iUni®. For that group, 30 patients will be included in the study and analyzed. The final follow-up after 24 months has already been documented by the study center. Compared to that, a consecutive series of 50 Univation® X patients will be invited for a 24 months follow-up in 2018. In total, it is planned to include 80 retrospective patients for that historical control study design.
The products under investigation were used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Univation® X | – | Device: Primary Unicompartmental Knee Arthroplasty |
| iUni® | – | Device: Primary Unicompartmental Knee Arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (2 listed)
- Patients who underwent UKA in 2015/2016 (using one of the products under investigation)
- Signed informed consent
Key exclusion criteria (2 listed)
- pregnancy
- patients < 18 years
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 |
|---|---|---|
| Primary Unicompartmental Knee ArthroplastyPrimary implantation of an unicompartmental knee implant | Device | Univation® X, iUni® |
Primary outcome
Knee joint function
Time frame: 2 years after primary implantation
Knee Society Score
4 secondary outcomes
KOOS
Time frame: 2 years after primary implantation
axis justice position
Time frame: preoperative and until discharge from hospital (within 1 week postoperatively)
radiolucent lines
Time frame: 2 years after primary implantation
tibial slope
Time frame: 2 years after primary implantation
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 15 Apr 2021.
- Derived from this study: PubMed 40866508Haaker R, Moussa A, Sabev D. No advantage for patient-specific UKA in comparison with standard UKA regarding clinical and functional results at short-term follow-up. Eur J Orthop Surg Traumatol. 2025 Aug 27;35(1):362. doi: 10.1007/s00590-025-04467-2.
- Individual participant dataSharing planned: No
Related trials for Unicompartmental Knee Arthroplasty
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
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Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant
Gonarthritis, Degenerative Disease
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Post-op Prednisone and Glucose Monitoring in TKA
Osteoarthritis, Unicompartmental Knee Arthroplasty
RecruitingObservational study
Changes in Physical Activity, Sleep and Knee Function After Same-Day Discharge Knee Arthroplasty
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Active, not recruiting
Unicompartmental Versus Total Knee Replacement for Medial Compartment Knee Osteoarthritis
Osteoarthritis, Knee
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 Unicompartmental Knee Arthroplasty, run by Aesculap AG at 1 site in Germany.
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 2 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 15 Apr 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 Germany. 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?
Knee joint function (time frame: 2 years after primary implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03201172, which also lists 1 linked publication.
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 15 Apr 2021.