NCT01469403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 17, 2015

Status Verified

November 1, 2011

Enrollment Period

2.8 years

First QC Date

September 7, 2011

Last Update Submit

March 16, 2015

Conditions

Osteoarthritis, KneeObesity

Keywords

Osteoarthritis, kneeObesityWeight LossArthroplasty

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (22)

  • 6 minutes walk test (6MW).

    Measured 1 week before surgery.

  • Body composition

    Measured 1 week before surgery.

  • Bone mineral density (BMD).

    Measured 12 months postoperatively.

  • KOOS

    Measured 1 week before surgery.

  • Pain

    Measured 1 week before surgery.

  • +17 more secondary outcomes

Study Arms (2)

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.

Behavioral: 8 weeks weight loss program, Cambridge.

Interventions

8 weeks weight loss program, Cambridge.BEHAVIORAL

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.

Weight loss program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopedics Research Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, KneeObesityWeight Loss

Interventions

Weight Reduction Programs

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Health PromotionHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Kjeld Søballe, Prof. D.Msc

    Department of Orthopedics Research Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2011

First Posted

November 10, 2011

Study Start

August 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

March 17, 2015

Record last verified: 2011-11

Locations

DK(1)