Weight Loss Intervention Before Total Knee Replacement

Obesity Clinical Trial

Official title:

Weight Loss Intervention Before Total Knee Replacement, a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469403
• Other study ID #: TKABMI
• Status: Completed
• Phase: N/A
• First received: September 7, 2011
• Last updated: March 16, 2015
• Start date: August 2011
• Est. completion date: June 2014

Study information

• Verified date: November 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical 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. 1 year after surgery the investigators will examine whether there are differences between the two groups' quality of life and functional capacity.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obesity
• Osteoarthritis
• Osteoarthritis, Knee
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Orthopedics Research Aarhus University Hospital	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Cambridge Weight Plan Limited, The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 12 months postoperatively.	No
Secondary	6 minutes walk test (6MW).	Used to target the operating level of the patient's daily activities.	Measured 1 week before surgery.	No
Secondary	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 1 week before surgery.	No
Secondary	Bone mineral density (BMD).	Measured by DEXA scan.	Measured 12 months postoperatively.	No
Secondary	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 1 week before surgery.	No
Secondary	Pain	Visual Analogue Scale (VAS pain score)	Measured 1 week before surgery.	No
Secondary	Serum leptin.	Leptin is a hormone produced in fat tissue.	Measured 1 week before surgery.	No
Secondary	Heart rate	Cardiovascular complications.	Measured 1 week before surgery.	No
Secondary	Blood pressure	Cardiovascular complications.	Measured 1 week before surgery.	No
Secondary	6 minutes walk test (6MW).	Used to target the operating level of the patient's daily activities.	Measured 8 week postoperatively.	No
Secondary	6 minutes walk test (6MW).	Used to target the operating level of the patient's daily activities.	Measured 12 months postoperatively	No
Secondary	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 8 week postoperatively	No
Secondary	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 12 months postoperatively	No
Secondary	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 8 week postoperatively	No
Secondary	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 12 months postoperatively	No
Secondary	Pain	Visual Analogue Scale (VAS pain score)	Measured 8 week postoperatively	No
Secondary	Pain	Visual Analogue Scale (VAS pain score)	Measured 12 months postoperatively	No
Secondary	Serum leptin.	Leptin is a hormone produced in fat tissue.	Measured 8 week postoperatively	No
Secondary	Serum leptin.	Leptin is a hormone produced in fat tissue.	Measured 12 months postoperatively	No
Secondary	Heart rate	Cardiovascular complications.	Measured 8 week postoperatively	No
Secondary	Heart rate	Cardiovascular complications.	Measured 12 months postoperatively	No
Secondary	Blood pressure	Cardiovascular complications.	Measured 8 week postoperatively	No
Secondary	Blood pressure	Cardiovascular complications.	Measured 12 months postoperatively	No