Total Knee ArthroplastyNCT02983929
Short-Term Follow-up Indicator for Total Knee Arthroplasty and Body Mass Index
An observational study of Total Knee Arthroplasty and Body Mass Index, run by Centre Hospitalier Durécu Lavoisier.
Trial summary
The main purpose of this study is to determine the influence of obesity on the short term follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee arthroplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Arthroplasty, Body Mass Index, Rehabilitation
- What is being tested?
- Rehabilitation after total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Nov 2016
- How long will I take part?
- 2 Months
- 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: Men and Women admitted after total knee arthroplasty in Polyvalent Geriatric Rehabilitation Clinic.
Who may be able to join
- Patient admitted after total knee arthroplasty in Polyvalent Geriatric Rehabilitation Clinic during the january 2007/October 2016 period
Who cannot join
- Uncompleted case file or case file anterior to 2007 ;
- Inter-current orthopedic complication ;
- Evolutive or inter-current pathology written in the case-file (neurologic affection, etc...).
About this study
Official title: Impact of Elevated Body Mass Index on Short-term Follow-up Indicators for Total Knee Arthroplasty : a Retrospective Study
The main purpose of this study is to determine the influence of obesity on the short term follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee arthroplasty. It is a retrospective, comparative study
The secondary purposes are to explore the links between length of stay and short-term follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee arthroplasty.
- Conditions
- Total Knee Arthroplasty, Body Mass Index, Rehabilitation
- Being tested
- Rehabilitation after total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation after total knee arthroplastyProcedure or surgery
All the included patients followed a rehabilitation program in the Polyvalent Geriatric Rehabilitation Clinic after total knee arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| BMI <30 kg.m-2 | Patients with a BMI inferior to the obesity limit defined by the World Health Organization. Receives: Procedure: Rehabilitation after total knee arthroplasty | |
| BMI >30 kg.m-2 | Patients with a BMI superior to the obesity limit defined by the World Health Organization. Receives: Procedure: Rehabilitation after total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Measured: 2 Month
Range Of Motion of the Knee
The investigators will report the initial, final flexion and extension and calculate the total gain of flexion and extension of the knee for each participant.
Measured: 2 Month
Age
Measured: 2 Month
Mansat Score
This score is a composite score recommended by the French Authority of Health.
Measured: 2 Month
Secondary outcomes (1)
Length of stay
The investigators will report the length of stay in the rehabilitation clinic for each participant.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startJan 2007
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total 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
- Enrolment
- 244 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Durécu Lavoisier
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothée Gillot, Centre Hospitalier Durécu Lavoisier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983929
- Sponsor's protocol ID
- MK1
- Status last verified
- Dec 2016
- First submitted
- 29 Nov 2016
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Elevated Body Mass Index on Short-term Follow-up Indicators for Total Knee Arthroplasty : a Retrospective Study
- ClinicalTrials.gov ID
- NCT02983929
- Acronym / sponsor ID
- MK1
- Conditions
- Total Knee Arthroplasty, Body Mass Index, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Centre Hospitalier Durécu LavoisierUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 6 Dec 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 main purpose of this study is to determine the influence of obesity on the short term follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee arthroplasty. It is a retrospective, comparative study
The secondary purposes are to explore the links between length of stay and short-term follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee arthroplasty.
Study design
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI <30 kg.m-2 | – | Procedure: Rehabilitation after total knee arthroplastyPatients with a BMI inferior to the obesity limit defined by the World Health Organization. |
| BMI >30 kg.m-2 | – | Procedure: Rehabilitation after total knee arthroplastyPatients with a BMI superior to the obesity limit defined by the World Health Organization. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men and Women admitted after total knee arthroplasty in Polyvalent Geriatric Rehabilitation Clinic.
Key inclusion criteria (1 listed)
- Patient admitted after total knee arthroplasty in Polyvalent Geriatric Rehabilitation Clinic during the january 2007/October 2016 period
Key exclusion criteria (3 listed)
- Uncompleted case file or case file anterior to 2007 ;
- Inter-current orthopedic complication ;
- Evolutive or inter-current pathology written in the case-file (neurologic affection, etc...).
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 |
|---|---|---|
| Rehabilitation after total knee arthroplastyAll the included patients followed a rehabilitation program in the Polyvalent Geriatric Rehabilitation Clinic after total knee arthroplasty. | Procedure or surgery | BMI <30 kg.m-2, BMI >30 kg.m-2 |
Primary outcome
Body Mass Index
Time frame: 2 Month
Range Of Motion of the Knee
Time frame: 2 Month
The investigators will report the initial, final flexion and extension and calculate the total gain of flexion and extension of the knee for each participant.
Age
Time frame: 2 Month
Mansat Score
Time frame: 2 Month
This score is a composite score recommended by the French Authority of Health.
1 secondary outcome
Length of stay
Time frame: 2 month
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 8 Dec 2016.
Related trials for Total Knee Arthroplasty
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty and Body Mass Index, run by Centre Hospitalier Durécu Lavoisier.
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 1 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 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Body Mass Index (time frame: 2 Month). The study lists 4 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 8 Dec 2016.