NCT00373971

Brief Summary

Malnutrition of elder orthopaedic patients leads to weight loss and loss of fat free mass. Changes in the individual's nutritional status and body composition may adversely affect the patient's postoperative level of activity. Aim. Thus, the purpose of the present study is to report changes in postoperative weight, FFM and functions vital to daily living in a group of elder orthopaedic patients that were actively involved in their nutritional care during the hospital stay.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 1995

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1995

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 1998

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
Last Updated

September 8, 2006

Status Verified

September 1, 2006

First QC Date

September 7, 2006

Last Update Submit

September 7, 2006

Conditions

Hip FractureArthrosis

Keywords

Activities of daily livingElderlyNutritionPostoperativeHip fracturesHip replacementKnee replacement

Outcome Measures

Primary Outcomes (3)

  • Changes in weight

  • Changes in Fatt Free Mass

  • Changes in ADL-activities

Secondary Outcomes (2)

  • energy intake

  • Protein intake

Interventions

Involving the patients in their own nutritional careBEHAVIORAL

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65 and above admitted either for elective hip- or knee replacement or acute with a fractured hip were allocated to the study. Patients included in the study were to stay in hospital for more than 7 days and agree on coming to the outpatient clinic for a follow-up four months after surgery.

You may not qualify if:

  • Patients who refused to participate, patients were not able to understand the instructions,or received dietary treatment due to DM. Patients who suffered from cancer, gastrointestinal disorders or were undergoing steroid treatment. In addition, patients who were unable to participate due to serious heart disorders; or were transferred to intensive or cardiac units after surgery and did not return to the ward.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

County hopital of Koge

Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Hip FracturesOsteoarthritis

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Preben U Pedersen, phd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 8, 2006

Study Start

November 1, 1995

Study Completion

July 1, 1998

Last Updated

September 8, 2006

Record last verified: 2006-09

Locations

DK(1)