OsteoarthritisNCT02912351
A Post-Market Retrospective Study on Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis
An observational study of Osteoarthritis, run by Medacta USA at 1 site in United States.
Trial summary
This is a retrospective, single-site observational study, designed to assess the clinical outcomes and collect safety data of GMK Revision knee system used for primary or revision total knee arthroplasty at minimum two years post-treatment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Patient record review, Radiographs, and questionaires.
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Mar 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: For patients that had received the treatment modality, GMK Revision Knee System and are at least 2 years (24 months) out from surgery.
Who may be able to join
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to any study procedure.
- Patients with ability to understand and provide written authorization for use and disclosure of personal health information
- Patients must be willing to comply with the post-operative evaluation schedule.
- Patients underwent either a primary or revision total knee replacement for any type of etiology (Osteoarthritis, Avascular necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Polyarthritis, Primary implantation failure).
- Patients must have received a GMK Revision component
- Patients must be at minimum 2 year (24 months) post-treatment
- The operation was performed or supervised by the investigator.
- No age limit criteria
Who cannot join
- History of alcoholism
- Currently on chemotherapy or radiation therapy
- Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than knee pain
- History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
- History of chronic pain issues for reasons other than knee pain
- Women that are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post-Market, Single-Center, Retrospective Study to Collect Clinical Outcomes and Safety Data From Patients Who Have Undergone Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis and Are at Least 2 Years Past Surgery
This is a retrospective, single-site observational study, designed to assess the clinical outcomes and collect safety data of GMK Revision knee system used for primary or revision total knee arthroplasty at minimum two years post-treatment.
- Conditions
- Osteoarthritis
- Being tested
- Patient record review, Radiographs, and questionaires.
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement, Revision Knee Arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient record review, Radiographs, and questionaires.Other
KSS-Objective Knee Scores, KSS Subsets, Radiographs and Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Knee Society Scores (KSS)
Total Knee Society Score questionnaire to assess Patient satisfaction and Patient expectations and objective knee scores.
Measured: Minimum 2 years post surgery
Secondary outcomes (3)
Radiographic Analysis
Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration and the presence and progression of radiolucent line between the prosthesis, bone and cement.
Measured: Minimum 2 years post surgery
Patient Satisfaction
Assessed with a Likert scale questionnaire for satisfaction of treatment outcome.
Measured: Minimum 2 years post surgery
Complication Assessment
by reviewing Adverse Events
Measured: minimum 2 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2022
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mukesh Ahuja, MBBS, MS, Study director, Medacta USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912351
- Sponsor's protocol ID
- K102437-01
- Status last verified
- Mar 2022
- First submitted
- 4 Jan 2016
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market, Single-Center, Retrospective Study to Collect Clinical Outcomes and Safety Data From Patients Who Have Undergone Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis and Are at Least 2 Years Past Surgery
- ClinicalTrials.gov ID
- NCT02912351
- Acronym / sponsor ID
- K102437-01
- Conditions
- Osteoarthritis
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement, Revision Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medacta USAIndustry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- Mar 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 23 Sep 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.
This is a retrospective, single-site observational study, designed to assess the clinical outcomes and collect safety data of GMK Revision knee system used for primary or revision total knee arthroplasty at minimum two years post-treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For patients that had received the treatment modality, GMK Revision Knee System and are at least 2 years (24 months) out from surgery.
Key inclusion criteria (8 listed)
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to any study procedure.
- Patients with ability to understand and provide written authorization for use and disclosure of personal health information
- Patients must be willing to comply with the post-operative evaluation schedule.
- Patients underwent either a primary or revision total knee replacement for any type of etiology (Osteoarthritis, Avascular necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Polyarthritis, Primary implantation failure).
- Patients must have received a GMK Revision component
Key exclusion criteria (6 listed)
- History of alcoholism
- Currently on chemotherapy or radiation therapy
- Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than knee pain
- History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
- History of chronic pain issues for reasons other than knee pain
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 |
|---|---|---|
| Patient record review, Radiographs, and questionaires.KSS-Objective Knee Scores, KSS Subsets, Radiographs and Patient Satisfaction | Other | – |
Primary outcome
Total Knee Society Scores (KSS)
Time frame: Minimum 2 years post surgery
Total Knee Society Score questionnaire to assess Patient satisfaction and Patient expectations and objective knee scores.
3 secondary outcomes
Radiographic Analysis
Time frame: Minimum 2 years post surgery
Patient Satisfaction
Time frame: Minimum 2 years post surgery
Complication Assessment
Time frame: minimum 2 years post surgery
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 1 Apr 2022.
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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.
Mukesh Ahuja, MBBS, MS study director
Medacta USA, Inc.
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 Osteoarthritis, run by Medacta USA at 1 site 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 8 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: finished, as of the sponsor's last update on 1 Apr 2022. 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 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 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?
Total Knee Society Scores (KSS) (time frame: Minimum 2 years post surgery). 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 1 Apr 2022.