Constrained Insert in Knee ArthroplastyNCT03202225
Primary Constrained Condylar Knee Arthroplasty Without Stem Extensions: Prevalence and Risk Factors
An observational study of Constrained Insert in Knee Arthroplasty, run by Navamindradhiraj University at 1 site in Thailand.
Trial summary
While performing a primary TKA in consecutive patients, a constrained insert may be necessary when adequate stability and soft tissue balance are not obtained. In this retrospective study, The investigators aim to identify the prevalence and risk factors that associate with the use of a constrained insert in primary… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Constrained Insert in Knee Arthroplasty
- What is being tested?
- constrained polyethylene
- Type of treatment
- Medical device
- How many people
- 246 participants
- Where
- 1 siteThailand
- Study dates
- 17 May 2017to Apr 2018
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: consecutive patients underwent primary total knee arthroplasty at our institution
Who may be able to join
- primary knee osteoarthritis
- primary total knee replacement
Who cannot join
- secondary knee osteoarthritis
- revision total knee replacement
- previous knee surgery
- post-traumatic knee
- history of previously infection
- comorbidity;rheumatoid arthritis, connective tissue disease, neuromuscular disease, lumbar spinal stenosis, neuropathy
- severe osteoporosis
Trial locations and contacts
1 site in 1 country.
About this study
While performing a primary TKA in consecutive patients, a constrained insert may be necessary when adequate stability and soft tissue balance are not obtained. In this retrospective study, The investigators aim to identify the prevalence and risk factors that associate with the use of a constrained insert in primary TKA.
- Conditions
- Constrained Insert in Knee Arthroplasty
- Being tested
- constrained polyethylene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
constrained polyethyleneDevice
constrained polyethylene insert
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence to use constrained insert in primary total knee arthroplasty
to identify the prevalence that associate with the use of a constrained insert in primary total knee arthroplasty
Measured: intraoperative
risk factors to use constrained insert in primary total knee arthroplasty
to identify the risk factors that associate with the use of a constrained insert in primary total knee arthroplasty such as degree of preoperative deformity, degree of preoperative instability
Measured: intraoperative
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 start17 May 2017
- Primary completionDec 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constrained Insert in 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
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navamindradhiraj University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satit Thiengwittayaporn, Navamindradhiraj University
- Investigators
- Satit Thiengwittayaporn, M.D., Principal investigator, Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202225
- Sponsor's protocol ID
- COA 61/2560
- Status last verified
- Nov 2017
- First submitted
- 25 Jun 2017
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Constrained Condylar Knee Arthroplasty Without Stem Extensions: Prevalence and Risk Factors
- ClinicalTrials.gov ID
- NCT03202225
- Acronym / sponsor ID
- COA 61/2560
- Conditions
- Constrained Insert in Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Navamindradhiraj UniversityUniversity, hospital or other
- Study start
- 17 May 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- 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.
While performing a primary TKA in consecutive patients, a constrained insert may be necessary when adequate stability and soft tissue balance are not obtained. In this retrospective study, The investigators aim to identify the prevalence and risk factors that associate with the use of a constrained insert in primary TKA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- consecutive patients underwent primary total knee arthroplasty at our institution
Key inclusion criteria (2 listed)
- primary knee osteoarthritis
- primary total knee replacement
Key exclusion criteria (7 listed)
- secondary knee osteoarthritis
- revision total knee replacement
- previous knee surgery
- post-traumatic knee
- history of previously infection
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 |
|---|---|---|
| constrained polyethyleneconstrained polyethylene insert | Device | – |
Primary outcome
prevalence to use constrained insert in primary total knee arthroplasty
Time frame: intraoperative
to identify the prevalence that associate with the use of a constrained insert in primary total knee arthroplasty
risk factors to use constrained insert in primary total knee arthroplasty
Time frame: intraoperative
to identify the risk factors that associate with the use of a constrained insert in primary total knee arthroplasty such as degree of preoperative deformity, degree of preoperative instability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
- Individual participant dataSharing planned: No
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.
Satit Thiengwittayaporn, M.D. principal investigator
Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
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 Constrained Insert in Knee Arthroplasty, run by Navamindradhiraj University at 1 site in Thailand.
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 7 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 21 Dec 2017. 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 Thailand. 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?
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?
prevalence to use constrained insert in primary total knee arthroplasty (time frame: intraoperative). 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 21 Dec 2017.