Osteoarthritis, KneeNCT01469403
Weight Loss Intervention Before Total Knee Replacement
A study testing 8 weeks weight loss program, Cambridge. in people with Osteoarthritis, Knee and Obesity, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to compare the efficacy in a group of patients who must follow the current procedure for treatment of artificial knee, compared with a group of patients who must undergo an 8-week weight loss program before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Obesity
- What is being tested?
- 8 weeks weight loss program, Cambridge.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to Jun 2014
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients recommended for primary total knee replacement.
- Body mass index > 30.
- Must be motivated for weight loss.
- Must be able to read and understand Danish.
Who cannot join
- Rheumatoid arthritis.
- Patients who are operated on both knees during the project period can only participate once.
- Planned obesity surgery.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Orthopedics Research Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Weight Loss Intervention Before Total Knee Replacement, a Randomized Controlled Trial
The purpose of this study is to compare the efficacy in a group of patients who must follow the current procedure for treatment of artificial knee, compared with a group of patients who must undergo an 8-week weight loss program before surgery. 1 year after surgery the investigators will examine whether there are differences between the two groups' quality of life and functional capacity.
Read the detailed description
Background In Denmark the numbers of primary total knee arthroplasty (TKA) operations annually increase. In the year 2000 was performed approximately 2,500 operations and in 2008 was performed more than 7,500 total knee arthroplasty operations, and there appears in all countries to be similar tendency. Meanwhile, the prevalence of overweight and obesity has increased markedly over the last 50 years. Approximately 13% of the Danish population is obese. For several years the association between obesity and knee osteoarthritis (OA) has been recognized, and osteoarthritis is the most frequent indication for total knee arthroplasty(80%).
The purpose of this study is to investigate whether weight loss interventions before primary total knee arthroplasty will improve quality of life and functional level, reduce pain and risk of early and late postoperative complications.
Sample size Significance level is set to 5% by using a 2-sided analysis and the power is set at 80%. Based on an expectation of a difference in patient-reported outcome scores in between the groups at 8%, as measured by SF-36 12 months postoperatively, standard deviation (SD) 13 must be include 41 participants in each group. To allow a drop-out rate of 20% the group size increases to 51 participants in each group. In total 102 participants.
Statistical analysis, The two groups scores at 12 months postoperatively, and the two groups' change in the primary outcome measurer, from 1 week before surgery to 12 months postoperatively, compared with t-test or Mann-Whitney test rang sum depending on data distribution.
- Conditions
- Osteoarthritis, Knee, Obesity
- Being tested
- 8 weeks weight loss program, Cambridge.
- Keywords
- Osteoarthritis, knee, Obesity, Weight Loss, Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8 weeks weight loss program, Cambridge.Behavioural
Fast weight losses improve the prognosis for the sustained weight loss. During the first week a dietitian will tutor the participants in formula food diet (The Cambridge Health and Weight plan UK.), followed by seven weeks with control guidance and instruction in healthy eating habits once a week. The guidance by the dietitian will be carried out both on an individual basis and in groups. The goal of the intervention is to achieve a preoperative weight loss of at least 5 to 10% of the patient's body weight, thus improving patient's health before surgery.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Standard procedure for knee arthroplasty |
| Weight loss program | Active comparator | The intervention program consists of 8 weeks of low-diet, using formula foods, and dietary counseling before surgery. When using formula foods the patients can achieve a quicker weight reduction and a greater reduction in fat mass than using conventional dietetic hypo caloric diet. Receives: Behavioral: 8 weeks weight loss program, Cambridge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36
A patient reported outcome (PRO). The questionnaire is a tool for measuring health status. The form is used to measure the patient's view of his own health by scoring standardized responses to standardized questions. The schedule consists of 36 questions representing eight health concepts.
Measured: Measured 12 months postoperatively.
Secondary outcomes (22)
6 minutes walk test (6MW).
Used to target the operating level of the patient's daily activities.
Measured: Measured 1 week before surgery.
Body composition
Dual energy X-ray absorptiometry (DEXA) can measure total body bone mineral density and obtain accurate measurements of body tissue composition (muscle mass and fat mass). By measuring the body's muscle mass, fat mass and bone mineral density, one can estimate total body fat percentage.
Measured: Measured 1 week before surgery.
Bone mineral density (BMD).
Measured by DEXA scan.
Measured: Measured 12 months postoperatively.
KOOS
Knee - specific patient-reported outcome that measures the patient's own assessment of knee problems and related problems. The schedule consists of 42 questions representing 5 strands.
Measured: Measured 1 week before surgery.
Pain
Visual Analogue Scale (VAS pain score)
Measured: Measured 1 week before surgery.
Serum leptin.
Leptin is a hormone produced in fat tissue.
Measured: Measured 1 week before surgery.
Heart rate
Cardiovascular complications.
Measured: Measured 1 week before surgery.
Blood pressure
Cardiovascular complications.
Measured: Measured 1 week before surgery.
6 minutes walk test (6MW).
Used to target the operating level of the patient's daily activities.
Measured: Measured 8 week postoperatively.
6 minutes walk test (6MW).
Used to target the operating level of the patient's daily activities.
Measured: Measured 12 months postoperatively
Body composition
Dual energy X-ray absorptiometry (DEXA) can measure total body bone mineral density and obtain accurate measurements of body tissue composition (muscle mass and fat mass). By measuring the body's muscle mass, fat mass and bone mineral density, one can estimate total body fat percentage.
Measured: Measured 8 week postoperatively
Body composition
Dual energy X-ray absorptiometry (DEXA) can measure total body bone mineral density and obtain accurate measurements of body tissue composition (muscle mass and fat mass). By measuring the body's muscle mass, fat mass and bone mineral density, one can estimate total body fat percentage.
Measured: Measured 12 months postoperatively
KOOS
Knee - specific patient-reported outcome that measures the patient's own assessment of knee problems and related problems. The schedule consists of 42 questions representing 5 strands.
Measured: Measured 8 week postoperatively
KOOS
Knee - specific patient-reported outcome that measures the patient's own assessment of knee problems and related problems. The schedule consists of 42 questions representing 5 strands.
Measured: Measured 12 months postoperatively
Pain
Visual Analogue Scale (VAS pain score)
Measured: Measured 8 week postoperatively
Pain
Visual Analogue Scale (VAS pain score)
Measured: Measured 12 months postoperatively
Serum leptin.
Leptin is a hormone produced in fat tissue.
Measured: Measured 8 week postoperatively
Serum leptin.
Leptin is a hormone produced in fat tissue.
Measured: Measured 12 months postoperatively
Heart rate
Cardiovascular complications.
Measured: Measured 8 week postoperatively
Heart rate
Cardiovascular complications.
Measured: Measured 12 months postoperatively
Blood pressure
Cardiovascular complications.
Measured: Measured 8 week postoperatively
Blood pressure
Cardiovascular complications.
Measured: Measured 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2014
- Study completionJun 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Rheumatism Association, Cambridge Weight Plan Limited
- Responsible party
- Sponsor
- Investigators
- Kjeld Søballe, Prof. D.Msc, Principal investigator, Department of Orthopedics Research Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469403
- Sponsor's protocol ID
- TKABMI
- Status last verified
- Nov 2011
- First submitted
- 7 Sep 2011
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Intervention Before Total Knee Replacement, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01469403
- Acronym / sponsor ID
- TKABMI
- Conditions
- Osteoarthritis, Knee, Obesity
- Keywords
- Osteoarthritis, knee, Obesity, Weight Loss, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Rheumatism Association, Cambridge Weight Plan Limited
- Study start
- Aug 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Nov 2011 (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 compare the efficacy in a group of patients who must follow the current procedure for treatment of artificial knee, compared with a group of patients who must undergo an 8-week weight loss program before surgery. 1 year after surgery the investigators will examine whether there are differences between the two groups' quality of life and functional capacity.
Detailed description
Background In Denmark the numbers of primary total knee arthroplasty (TKA) operations annually increase. In the year 2000 was performed approximately 2,500 operations and in 2008 was performed more than 7,500 total knee arthroplasty operations, and there appears in all countries to be similar tendency. Meanwhile, the prevalence of overweight and obesity has increased markedly over the last 50 years. Approximately 13% of the Danish population is obese. For several years the association between obesity and knee osteoarthritis (OA) has been recognized, and osteoarthritis is the most frequent indication for total knee arthroplasty(80%).
The purpose of this study is to investigate whether weight loss interventions before primary total knee arthroplasty will improve quality of life and functional level, reduce pain and risk of early and late postoperative complications.
Sample size Significance level is set to 5% by using a 2-sided analysis and the power is set at 80%. Based on an expectation of a difference in patient-reported outcome scores in between the groups at 8%, as measured by SF-36 12 months postoperatively, standard deviation (SD) 13 must be include 41 participants in each group. To allow a drop-out rate of 20% the group size increases to 51 participants in each group. In total 102 participants.
Statistical analysis, The two groups scores at 12 months postoperatively, and the two groups' change in the primary outcome measurer, from 1 week before surgery to 12 months postoperatively, compared with t-test or Mann-Whitney test rang sum depending on data distribution.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Standard procedure for knee arthroplasty |
| Weight loss program | Active comparator | Behavioral: 8 weeks weight loss program, Cambridge.The intervention program consists of 8 weeks of low-diet, using formula foods, and dietary counseling before surgery. When using formula foods the patients can achieve a quicker weight reduction and a greater reduction in fat mass than using conventional dietetic hypo caloric diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients recommended for primary total knee replacement.
- Body mass index > 30.
- Must be motivated for weight loss.
- Must be able to read and understand Danish.
Key exclusion criteria (3 listed)
- Rheumatoid arthritis.
- Patients who are operated on both knees during the project period can only participate once.
- Planned obesity surgery.
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 |
|---|---|---|
| 8 weeks weight loss program, Cambridge.Fast weight losses improve the prognosis for the sustained weight loss. During the first week a dietitian will tutor the participants in formula food diet (The Cambridge Health and Weight plan UK.), followed by seven weeks with control guidance and instruction in healthy eating habits once a week. The guidance by the dietitian will be carried out both on an individual basis and in groups. The goal of the intervention is to achieve a preoperative weight loss of at least 5 to 10% of the patient's body weight, thus improving patient's health before surgery. | Behavioural | Weight loss program |
Primary outcome
SF-36
Time frame: Measured 12 months postoperatively.
A patient reported outcome (PRO). The questionnaire is a tool for measuring health status. The form is used to measure the patient's view of his own health by scoring standardized responses to standardized questions. The schedule consists of 36 questions representing eight health concepts.
22 secondary outcomes
6 minutes walk test (6MW).
Time frame: Measured 1 week before surgery.
Body composition
Time frame: Measured 1 week before surgery.
Bone mineral density (BMD).
Time frame: Measured 12 months postoperatively.
KOOS
Time frame: Measured 1 week before surgery.
Pain
Time frame: Measured 1 week before surgery.
Serum leptin.
Time frame: Measured 1 week before surgery.
Heart rate
Time frame: Measured 1 week before surgery.
Blood pressure
Time frame: Measured 1 week before surgery.
6 minutes walk test (6MW).
Time frame: Measured 8 week postoperatively.
6 minutes walk test (6MW).
Time frame: Measured 12 months postoperatively
Body composition
Time frame: Measured 8 week postoperatively
Body composition
Time frame: Measured 12 months postoperatively
KOOS
Time frame: Measured 8 week postoperatively
KOOS
Time frame: Measured 12 months postoperatively
Pain
Time frame: Measured 8 week postoperatively
Pain
Time frame: Measured 12 months postoperatively
Serum leptin.
Time frame: Measured 8 week postoperatively
Serum leptin.
Time frame: Measured 12 months postoperatively
Heart rate
Time frame: Measured 8 week postoperatively
Heart rate
Time frame: Measured 12 months postoperatively
Blood pressure
Time frame: Measured 8 week postoperatively
Blood pressure
Time frame: Measured 12 months postoperatively
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 17 Mar 2015.
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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.
Kjeld Søballe, Prof. D.Msc principal investigator
Department of Orthopedics Research Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8 weeks weight loss program, Cambridge. in people with Osteoarthritis, Knee and Obesity, run by University of Aarhus at 1 site in Denmark.
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 4 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 17 Mar 2015. 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 Denmark. 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?
SF-36 (time frame: Measured 12 months postoperatively.). 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 17 Mar 2015.