Weight Loss Intervention Before Total Knee Replacement - Full Text View

Purpose

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.

Condition	Intervention
Osteoarthritis, Knee Obesity	Behavioral: 8 weeks weight loss program, Cambridge.

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Supportive Care
Official Title:	Weight Loss Intervention Before Total Knee Replacement, a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Obesity Osteoarthritis Weight Control

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

SF-36 [ Time Frame: Measured 12 months postoperatively. ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

6 minutes walk test (6MW). [ Time Frame: Measured 1 week before surgery. ] [ Designated as safety issue: No ]
Used to target the operating level of the patient's daily activities.
Body composition [ Time Frame: Measured 1 week before surgery. ] [ Designated as safety issue: No ]
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.
Bone mineral density (BMD). [ Time Frame: Measured 12 months postoperatively. ] [ Designated as safety issue: No ]
Measured by DEXA scan.
KOOS [ Time Frame: Measured 1 week before surgery. ] [ Designated as safety issue: No ]
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.
Pain [ Time Frame: Measured 1 week before surgery. ] [ Designated as safety issue: No ]
Visual Analogue Scale (VAS pain score)
Serum leptin. [ Time Frame: Measured 1 week before surgery. ] [ Designated as safety issue: No ]
Leptin is a hormone produced in fat tissue.
Heart rate [ Time Frame: Measured 1 week before surgery. ] [ Designated as safety issue: No ]
Cardiovascular complications.
Blood pressure [ Time Frame: Measured 1 week before surgery. ] [ Designated as safety issue: No ]
Cardiovascular complications.
6 minutes walk test (6MW). [ Time Frame: Measured 8 week postoperatively. ] [ Designated as safety issue: No ]
Used to target the operating level of the patient's daily activities.
6 minutes walk test (6MW). [ Time Frame: Measured 12 months postoperatively ] [ Designated as safety issue: No ]
Used to target the operating level of the patient's daily activities.
Body composition [ Time Frame: Measured 8 week postoperatively ] [ Designated as safety issue: No ]
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.
Body composition [ Time Frame: Measured 12 months postoperatively ] [ Designated as safety issue: No ]
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.
KOOS [ Time Frame: Measured 8 week postoperatively ] [ Designated as safety issue: No ]
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.
KOOS [ Time Frame: Measured 12 months postoperatively ] [ Designated as safety issue: No ]
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.
Pain [ Time Frame: Measured 8 week postoperatively ] [ Designated as safety issue: No ]
Visual Analogue Scale (VAS pain score)
Pain [ Time Frame: Measured 12 months postoperatively ] [ Designated as safety issue: No ]
Visual Analogue Scale (VAS pain score)
Serum leptin. [ Time Frame: Measured 8 week postoperatively ] [ Designated as safety issue: No ]
Leptin is a hormone produced in fat tissue.
Serum leptin. [ Time Frame: Measured 12 months postoperatively ] [ Designated as safety issue: No ]
Leptin is a hormone produced in fat tissue.
Heart rate [ Time Frame: Measured 8 week postoperatively ] [ Designated as safety issue: No ]
Cardiovascular complications.
Heart rate [ Time Frame: Measured 12 months postoperatively ] [ Designated as safety issue: No ]
Cardiovascular complications.
Blood pressure [ Time Frame: Measured 8 week postoperatively ] [ Designated as safety issue: No ]
Cardiovascular complications.
Blood pressure [ Time Frame: Measured 12 months postoperatively ] [ Designated as safety issue: No ]
Cardiovascular complications.

Estimated Enrollment:	102
Study Start Date:	August 2011
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: control group Standard procedure for knee arthroplasty
Active Comparator: Weight loss program 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.	Behavioral: 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.

Arms

Assigned Interventions

No Intervention: control group

Standard procedure for knee arthroplasty

Active Comparator: Weight loss program

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.

Behavioral: 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Rheumatoid arthritis.
Patients who are operated on both knees during the project period can only participate once.
Planned obesity surgery.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469403

Contacts

Contact: Anette Liljensøe, PhD-student

+45 2296 9301

anette.liljensoe@ki.au.dk

Locations

Denmark
Department of Orthopedics Research Aarhus University Hospital	Recruiting
Aarhus, Denmark, 8000
Contact: Anette Liljensøe, PhD-student +45 2296 9301 anette.liljensoe@ki.au.dk
Principal Investigator: Anette Liljensøe, PhD-student
Principal Investigator: Inger Mechlenburg, Assoc. Prof.
Principal Investigator: Henning Bliddal, Professor
Principal Investigator: Jens Ole Lauersen, MD
Principal Investigator: Kjeld Søballe, Professor

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator:

Kjeld Søballe, Prof. D.Msc

Department of Orthopedics Research Aarhus University Hospital

More Information

No publications provided

Responsible Party:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT01469403 History of Changes
Other Study ID Numbers:	TKABMI
Study First Received:	September 7, 2011
Last Updated:	November 1, 2012
Health Authority:	Denmark: Danish Dataprotection Agency Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

Osteoarthritis, knee
Obesity
Weight Loss
Arthroplasty

Additional relevant MeSH terms:

Obesity
Osteoarthritis
Weight Loss
Osteoarthritis, Knee
Overnutrition
Nutrition Disorders
Overweight

Body Weight
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Body Weight Changes

ClinicalTrials.gov processed this record on May 21, 2013