Osteoarthritis KneeNCT02050438
How Total Knee Prosthesis Dessigns Influence in Quality of Live
An observational study of Osteoarthritis Knee and Total Knee Replacement, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether different kind of prostesis designs influences in the quality of life of patients Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Osteoarthritis Knee, Total Knee Replacement
- What is being tested?
- Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 135 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Jul 2014
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients operated Total Knee Arthroplasty 6 months previously the observational study
Who may be able to join
- Aged 65-80 years.
- Primary Ostheortritis
- Mechanical Axis 0+/- 7 degrees
Who cannot join
- Patients with any new important disease after the surgical procedure.
- Important complications related with the surgical procedure, as fractures, infections and vascular lesions.
- Patients not following a rehabilitation program
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether different kind of prostesis designs influences in the quality of life of patients
Read the detailed description
Objectiu Criteris d'inclusió Mesura dels resultats
- Conditions
- Osteoarthritis Knee, Total Knee Replacement
- Being tested
- Total Knee Arthroplasty
- Keywords
- Osteoarthritis Knee, Total Knee Arthroplasty, Quality of Life
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
Also called Total Knee Prostesis
| Study group | Role | What they receive |
|---|---|---|
| Knee Osteoarthritis patients with prostesis treatment | Patients operated previously of Knee Osteoarthritis with different prostesis designs according the Hospital guide Receives: Procedure: Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Measured: 6 months
Secondary outcomes (1)
Functional Results
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis KneeStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Villalba Modol, Corporacion Parc Tauli
- Investigators
- Jordi Villaba-Modol, MD, Principal investigator, Corporacio Sanitaria Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050438
- Sponsor's protocol ID
- COTCSPT1JV
- Status last verified
- Jul 2014
- First submitted
- 29 Jan 2014
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Total Knee Prosthesis Dessigns Influence in Quality of Live
- ClinicalTrials.gov ID
- NCT02050438
- Acronym / sponsor ID
- COTCSPT1JV
- Conditions
- Osteoarthritis Knee, Total Knee Replacement
- Keywords
- Osteoarthritis Knee, Total Knee Arthroplasty, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- First posted
- 30 Jan 2014 (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 purpose of this study is to determine whether different kind of prostesis designs influences in the quality of life of patients
Detailed description
Objectiu Criteris d'inclusió Mesura dels resultats
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee Osteoarthritis patients with prostesis treatment | – | Procedure: Total Knee ArthroplastyPatients operated previously of Knee Osteoarthritis with different prostesis designs according the Hospital guide |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients operated Total Knee Arthroplasty 6 months previously the observational study
Key inclusion criteria (3 listed)
- Aged 65-80 years.
- Primary Ostheortritis
- Mechanical Axis 0+/- 7 degrees
Key exclusion criteria (3 listed)
- Patients with any new important disease after the surgical procedure.
- Important complications related with the surgical procedure, as fractures, infections and vascular lesions.
- Patients not following a rehabilitation program
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 |
|---|---|---|
| Total Knee ArthroplastyAlso: Total Knee Prostesis | Procedure or surgery | Knee Osteoarthritis patients with prostesis treatment |
Primary outcome
Quality of Life
Time frame: 6 months
1 secondary outcome
Functional Results
Time frame: 6 months
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 28 Jul 2014.
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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.
Jordi Villaba-Modol, MD principal investigator
Corporacio Sanitaria Parc Tauli
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 Knee and Total Knee Replacement, run by Corporacion Parc Tauli at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 28 Jul 2014. 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 Spain. 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?
Quality of Life (time frame: 6 months). 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 28 Jul 2014.