Patients With Total Knee Arthroplasty Using the VEGA SystemNCT01768871
Evaluation of the VEGA Knee System® Range of Motion
An observational study of Patients With Total Knee Arthroplasty Using the VEGA System, run by Aesculap Implant Systems at 3 sites in United States.
Trial summary
The primary objective of this study is to evaluate the function of the knee after a total knee replacement with the VEGA system®. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Patients With Total Knee Arthroplasty Using the VEGA System
- How many people
- 7 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2013to Jul 2015
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone a total knee arthroplasty with the VEGA knee system®
Who may be able to join
- willing to sign the informed consent.
- Patient has intact collateral ligaments.
Who cannot join
- Inflammatory arthritis
- Patients that have had a high tibial osteotomy or femoral osteotomy
- Patients with neuromuscular or neurosensory deficiency which would make it difficult to assess the device performance.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Charles J DePaolo, MD, PA
Asheville, North Carolina, 28801
Rose Medical Center
Denver, Colorado, 80220
DBA Hussamy Sports and Hand Center
Vero Beach, Florida, 32960
About this study
Official title: Prospective, Long-Term, Multi-Center Study on the Efficacy of the VEGA System® for Total Knee Arthroplasty.
The primary objective of this study is to evaluate the function of the knee after a total knee replacement with the VEGA system®.
Read the detailed description
To evaluate patients after total knee arthroplasty in terms of function for five years.
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC
WOMAC function score 2 years post arthroplasty
Measured: Two years
Secondary outcomes (1)
Health related quality of life
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Total Knee Arthroplasty Using the VEGA SystemStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap Implant Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khaled Saleh, Study chair, Southern Illinois University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768871
- Sponsor's protocol ID
- AAG-O-H-1105
- Status last verified
- Nov 2018
- First submitted
- 14 Jan 2013
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Long-Term, Multi-Center Study on the Efficacy of the VEGA System® for Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT01768871
- Acronym / sponsor ID
- AAG-O-H-1105
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Aesculap Implant SystemsIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Jan 2013 (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 primary objective of this study is to evaluate the function of the knee after a total knee replacement with the VEGA system®.
Detailed description
To evaluate patients after total knee arthroplasty in terms of function for five years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone a total knee arthroplasty with the VEGA knee system®
Key inclusion criteria (2 listed)
- willing to sign the informed consent.
- Patient has intact collateral ligaments.
Key exclusion criteria (3 listed)
- Inflammatory arthritis
- Patients that have had a high tibial osteotomy or femoral osteotomy
- Patients with neuromuscular or neurosensory deficiency which would make it difficult to assess the device performance.
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
WOMAC
Time frame: Two years
WOMAC function score 2 years post arthroplasty
1 secondary outcome
Health related quality of life
Time frame: Two years
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
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.
Khaled Saleh study chair
Southern Illinois University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Total Knee Arthroplasty Using the VEGA System, run by Aesculap Implant Systems at 3 sites in United States.
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 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: stopped early, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 was stopped early (reason given: low enrollment). Results are not available in the source record.
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?
WOMAC (time frame: Two years). 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 14 Nov 2018.