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Weight Loss Intervention Before Total Knee Replacement

Primary Purpose

Osteoarthritis, Knee, Obesity

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
8 weeks weight loss program, Cambridge.
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, knee, Obesity, Weight Loss, Arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Orthopedics Research Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control group

Weight loss program

Arm Description

Standard procedure for knee arthroplasty

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

6 minutes walk test (6MW).
Used to target the operating level of the patient's daily activities.
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.
Bone mineral density (BMD).
Measured by DEXA scan.
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.
Pain
Visual Analogue Scale (VAS pain score)
Serum leptin.
Leptin is a hormone produced in fat tissue.
Heart rate
Cardiovascular complications.
Blood pressure
Cardiovascular complications.
6 minutes walk test (6MW).
Used to target the operating level of the patient's daily activities.
6 minutes walk test (6MW).
Used to target the operating level of the patient's daily activities.
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.
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.
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.
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.
Pain
Visual Analogue Scale (VAS pain score)
Pain
Visual Analogue Scale (VAS pain score)
Serum leptin.
Leptin is a hormone produced in fat tissue.
Serum leptin.
Leptin is a hormone produced in fat tissue.
Heart rate
Cardiovascular complications.
Heart rate
Cardiovascular complications.
Blood pressure
Cardiovascular complications.
Blood pressure
Cardiovascular complications.

Full Information

First Posted
September 7, 2011
Last Updated
March 16, 2015
Sponsor
University of Aarhus
Collaborators
The Danish Rheumatism Association, Cambridge Weight Plan Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01469403
Brief Title
Weight Loss Intervention Before Total Knee Replacement
Official Title
Weight Loss Intervention Before Total Knee Replacement, a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
The Danish Rheumatism Association, Cambridge Weight Plan Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Obesity
Keywords
Osteoarthritis, knee, Obesity, Weight Loss, Arthroplasty

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Standard procedure for knee arthroplasty
Arm Title
Weight loss program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
8 weeks weight loss program, Cambridge.
Intervention Description
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.
Primary Outcome Measure Information:
Title
SF-36
Description
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.
Time Frame
Measured 12 months postoperatively.
Secondary Outcome Measure Information:
Title
6 minutes walk test (6MW).
Description
Used to target the operating level of the patient's daily activities.
Time Frame
Measured 1 week before surgery.
Title
Body composition
Description
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.
Time Frame
Measured 1 week before surgery.
Title
Bone mineral density (BMD).
Description
Measured by DEXA scan.
Time Frame
Measured 12 months postoperatively.
Title
KOOS
Description
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.
Time Frame
Measured 1 week before surgery.
Title
Pain
Description
Visual Analogue Scale (VAS pain score)
Time Frame
Measured 1 week before surgery.
Title
Serum leptin.
Description
Leptin is a hormone produced in fat tissue.
Time Frame
Measured 1 week before surgery.
Title
Heart rate
Description
Cardiovascular complications.
Time Frame
Measured 1 week before surgery.
Title
Blood pressure
Description
Cardiovascular complications.
Time Frame
Measured 1 week before surgery.
Title
6 minutes walk test (6MW).
Description
Used to target the operating level of the patient's daily activities.
Time Frame
Measured 8 week postoperatively.
Title
6 minutes walk test (6MW).
Description
Used to target the operating level of the patient's daily activities.
Time Frame
Measured 12 months postoperatively
Title
Body composition
Description
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.
Time Frame
Measured 8 week postoperatively
Title
Body composition
Description
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.
Time Frame
Measured 12 months postoperatively
Title
KOOS
Description
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.
Time Frame
Measured 8 week postoperatively
Title
KOOS
Description
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.
Time Frame
Measured 12 months postoperatively
Title
Pain
Description
Visual Analogue Scale (VAS pain score)
Time Frame
Measured 8 week postoperatively
Title
Pain
Description
Visual Analogue Scale (VAS pain score)
Time Frame
Measured 12 months postoperatively
Title
Serum leptin.
Description
Leptin is a hormone produced in fat tissue.
Time Frame
Measured 8 week postoperatively
Title
Serum leptin.
Description
Leptin is a hormone produced in fat tissue.
Time Frame
Measured 12 months postoperatively
Title
Heart rate
Description
Cardiovascular complications.
Time Frame
Measured 8 week postoperatively
Title
Heart rate
Description
Cardiovascular complications.
Time Frame
Measured 12 months postoperatively
Title
Blood pressure
Description
Cardiovascular complications.
Time Frame
Measured 8 week postoperatively
Title
Blood pressure
Description
Cardiovascular complications.
Time Frame
Measured 12 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjeld Søballe, Prof. D.Msc
Organizational Affiliation
Department of Orthopedics Research Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopedics Research Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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Weight Loss Intervention Before Total Knee Replacement

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