Unicompartmental Knee ArthroplastyUKANCT02949336
Kinematics Analysis of SIGMA® Partial Knee System
An observational study of Unicompartmental Knee Arthroplasty, run by Stephen Ferguson at 1 site in Switzerland.
Trial summary
The proposed study is a prospective collection of health related personal data (observational study). A total of approximately 10 subjects with traditional medial SIGMA® High Performance Partial Knee System and 10 ACL deficient subjects with medial SIGMA® High Performance Partial Knee System are analyzed during… 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?
- Observational use of fluoroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Dec 2016to 11 Dec 2017
- 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 clinical investigators of the participating clinics (PD Dr. med. Fabian von Knoch, Gelenkzentrum Zürich; and Dr. med. Stefan Preiss, Schulthess Klinik) will identify potential subjects based on clinical records. PD Dr. med. Fabian von Knoch will recruit patients he operated on at the Gelenkzentrum Zürich while Dr. med. Stefan Preiss will recruit subjects from his patient population at the Schulthess Klinik.
Who may be able to join
- medial SIGMA® High Performance Partial Knee System due to medial OA
- Intact/functional ACL
- BMI ≤ 32
- good clinical outcome, KOOS >70
- no or very low pain VAS < 2
- Follow-up at least one year post-op
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- Standardized general health survey score (SF-12) within the normal range for people in their age group
- Age ≥ 18 years
- medial SIGMA® High Performance Partial Knee System due to medial OA
- Deficient / non-functional ACL
- Central to posterior wear of medial tibial plateau (pre-op MRI)
- 50% reduced tibial posterior slope after UKA (post-op radiograph)
- BMI ≤ 32
- good clinical outcome, KOOS >70
- no or very low pain VAS < 2
- Follow-up at least one year post-op
- Standardized general health survey score (SF-12) within the normal range for people in their age group
- Age ≥ 18 years
Who cannot join
- Actual significant problem on lower extremities
- Misaligned UKA
- Deficient / non-functional ACL (Lachman Test)
- Any other arthroplasty at the lower extremities
- Patient incapable to understand and sign informed consent
- Incapable of performing the motion tasks
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- Pregnancy
- Actual significant problem on lower extremities
- Misaligned UKA / non-reduced posterior tibial slope (post-op radiograph)
- Intact / functional ACL
- Any other arthroplasty at the lower extremities
- Patient incapable to understand and sign informed consent
- Incapable of performing the motion tasks
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Institute for Biomechanics, ETH Zurich
Zurich, Canton of Zurich, 8093
About this study
Official title: Kinematics Analysis: Traditional (ACL Retaining) and ACL Deficient (Reduced Tibial Slope) Medial, Fixed Bearing Primary Unicondylar Knee Arthroplasty With the SIGMA® High Performance Partial Knee System
The proposed study is a prospective collection of health related personal data (observational study). A total of approximately 10 subjects with traditional medial SIGMA® High Performance Partial Knee System and 10 ACL deficient subjects with medial SIGMA® High Performance Partial Knee System are analyzed during sitting onto a chair and getting up, deep knee bend, stance and swing phase of level walking, downhill walking (ramp descent) and stair descent at least 12 months post-operatively, in terms of 3D fluoroscopic assessed tibio-femoral motion as well as simultaneous skin marker assessed whole leg motion and ground reaction forces. All the video-fluoroscopic testing is performed at the Institute for Biomechanics at the ETH Zurich. The UKA subjects are recruited based on the inclusion and exclusion criteria.
The primary objective is to quantify and describe the three-dimensional kinematics for patients with a traditional medial SIGMA® High Performance Partial Knee System (functional ACL and tibial posterior slope matching the native bone) during these daily activities.
The secondary objective is to evaluate patients with the same medial UKA implant (SIGMA® High Performance Partial Knee System) in an ACL deficient knee, where the UKA was implanted at a 50% reduced tibial posterior slope relative to the native knee.
Read the detailed description
The knee arthroplasty for each patient was implanted more than one year ago as per inclusion criteria of this study with the sole purpose of standard clinical practice of the recruiting surgeons.
- Conditions
- Unicompartmental Knee Arthroplasty
- Being tested
- Observational use of fluoroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational use of fluoroscopyRadiation
Minimal radiation exposure (0.17 mSv) for observational purpose
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Traditional UKA | Patients with a traditional Medial Unicompartmental Knee Arthroplasty, SIGMA® High Performance Partial Knee System (functional ACL and tibial posterior slope matching the native bone) will undergo observational use of fluoroscopy to analyze joint kinematics Receives: Radiation: Observational use of fluoroscopy | |
| Group 2: ACL deficient UKA | Patients with the same medial UKA implant (SIGMA® High Performance Partial Knee System) in an ACL deficient knee, where the UKA was implanted at a 50% reduced tibial posterior slope relative to the native knee will undergo observational use of fluoroscopy to analyze joint kinematics. Receives: Radiation: Observational use of fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Kinematics
The primary outcome of this study is the relationship between the knee flexion angle and the medial and lateral anterior-posterior translation of the condyles during sitting onto a chair and getting up, deep knee bend, stance and swing phase of level walking, downhill walking (ramp descent) and stair descent.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start19 Dec 2016
- Primary completion11 Sep 2017
- Study completion11 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen Ferguson
- Sponsor type
- University, hospital or other
- Collaborators
- Schulthess Klinik, DePuy Synthes, Gelenkzentrum Zurich
- Responsible party
- Sponsor-investigator, Stephen Ferguson, Institute for Biomechanics, ETH Zürich
- Investigators
- Stephen Ferguson, Prof. Dr., Study director, Institute for Biomechanics, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949336
- Sponsor's protocol ID
- UKA V 2.4 02.09.2016
- Acronym
- UKA
- Status last verified
- Jan 2019
- First submitted
- 24 Oct 2016
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematics Analysis: Traditional (ACL Retaining) and ACL Deficient (Reduced Tibial Slope) Medial, Fixed Bearing Primary Unicondylar Knee Arthroplasty With the SIGMA® High Performance Partial Knee System
- ClinicalTrials.gov ID
- NCT02949336
- Acronym / sponsor ID
- UKA / UKA V 2.4 02.09.2016
- Conditions
- Unicompartmental Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Stephen FergusonUniversity, hospital or other
- Collaborators
- Schulthess Klinik, DePuy Synthes, Gelenkzentrum Zurich
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 11 Sep 2017 (actual)
- Study completion
- 11 Dec 2017 (actual)
- First posted
- 31 Oct 2016 (estimated)
- 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 proposed study is a prospective collection of health related personal data (observational study). A total of approximately 10 subjects with traditional medial SIGMA® High Performance Partial Knee System and 10 ACL deficient subjects with medial SIGMA® High Performance Partial Knee System are analyzed during sitting onto a chair and getting up, deep knee bend, stance and swing phase of level walking, downhill walking (ramp descent) and stair descent at least 12 months post-operatively, in terms of 3D fluoroscopic assessed tibio-femoral motion as well as simultaneous skin marker assessed whole leg motion and ground reaction forces. All the video-fluoroscopic testing is performed at the Institute for Biomechanics at the ETH Zurich. The UKA subjects are recruited based on the inclusion and exclusion criteria.
The primary objective is to quantify and describe the three-dimensional kinematics for patients with a traditional medial SIGMA® High Performance Partial Knee System (functional ACL and tibial posterior slope matching the native bone) during these daily activities.
The secondary objective is to evaluate patients with the same medial UKA implant (SIGMA® High Performance Partial Knee System) in an ACL deficient knee, where the UKA was implanted at a 50% reduced tibial posterior slope relative to the native knee.
Detailed description
The knee arthroplasty for each patient was implanted more than one year ago as per inclusion criteria of this study with the sole purpose of standard clinical practice of the recruiting surgeons.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Traditional UKA | – | Radiation: Observational use of fluoroscopyPatients with a traditional Medial Unicompartmental Knee Arthroplasty, SIGMA® High Performance Partial Knee System (functional ACL and tibial posterior slope matching the native bone) will undergo observational use of fluoroscopy to analyze joint kinematics |
| Group 2: ACL deficient UKA | – | Radiation: Observational use of fluoroscopyPatients with the same medial UKA implant (SIGMA® High Performance Partial Knee System) in an ACL deficient knee, where the UKA was implanted at a 50% reduced tibial posterior slope relative to the native knee will undergo observational use of fluoroscopy to analyze joint kinematics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The clinical investigators of the participating clinics (PD Dr. med. Fabian von Knoch, Gelenkzentrum Zürich; and Dr. med. Stefan Preiss, Schulthess Klinik) will identify potential subjects based on clinical records. PD Dr. med. Fabian von Knoch will recruit patients he operated on at the Gelenkzentrum Zürich while Dr. med. Stefan Preiss will recruit subjects from his patient population at the Schulthess Klinik.
Key inclusion criteria (18 listed)
- medial SIGMA® High Performance Partial Knee System due to medial OA
- Intact/functional ACL
- BMI ≤ 32
- good clinical outcome, KOOS >70
- no or very low pain VAS < 2
Key exclusion criteria (14 listed)
- Actual significant problem on lower extremities
- Misaligned UKA
- Deficient / non-functional ACL (Lachman Test)
- Any other arthroplasty at the lower extremities
- Patient incapable to understand and sign informed consent
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 |
|---|---|---|
| Observational use of fluoroscopyMinimal radiation exposure (0.17 mSv) for observational purpose | Radiation | Group 1: Traditional UKA, Group 2: ACL deficient UKA |
Primary outcome
Knee Kinematics
Time frame: 3 hours
The primary outcome of this study is the relationship between the knee flexion angle and the medial and lateral anterior-posterior translation of the condyles during sitting onto a chair and getting up, deep knee bend, stance and swing phase of level walking, downhill walking (ramp descent) and stair descent.
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 23 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Stephen Ferguson, Prof. Dr. study director
Institute for Biomechanics, ETH Zurich
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 Stephen Ferguson at 1 site in Switzerland.
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 18 inclusion and 14 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 23 Jan 2019. 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 Switzerland. 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 Kinematics (time frame: 3 hours). 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 23 Jan 2019.