The Effect of PROCRIT (Epoetin Alfa) on Postoperative Vigor and Handgrip Strength (VIGOR Study)
The Effect of PROCRIT on Hemoglobin and Hematocrit and the Relationship to Postoperative Function, Vigor and Strength in Patients Undergoing Primary Total Joint Arthroplasty: A Randomized, Parallel Group, Open-Label Trial
1 other identifier
interventional
289
0 countries
N/A
Brief Summary
The purpose of this study was to compare the effect of epoetin alfa to preoperative autologous blood donation (PAD) on postoperative vigor (a measure of functional ability and well-being) and handgrip strength in patients undergoing hip or knee surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 1999
Typical duration for phase_4
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
February 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
November 17, 2006
CompletedFirst Posted
Study publicly available on registry
November 22, 2006
CompletedApril 6, 2010
April 1, 2010
November 17, 2006
April 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in VIGOR score (as assessed by questionnaire) from baseline to 1) within 24 hours of surgery; 2) post-op Day 2; 3) Day 4 or 5 or hospital discharge; and 4) between post-op days 14 and 21.
Secondary Outcomes (1)
Handgrip strength (JAMAR Hand Dynamometer using the stronger hand and in a standardized position and method repeated 3 times - the maximum force exerted was recorded), hemoglobin, and incidence of transfusion as described for primary outcome intervals.
Interventions
Eligibility Criteria
You may qualify if:
- Scheduled for elective unilateral (one joint), primary total joint arthroplasty of hip or knee
- pretreatment hemoglobin level of 11 to 14 g/dL
- enrollment 21-60 days in advance of surgery
You may not qualify if:
- No uncontrolled hypertension
- No seizure disorder
- No history of deep vein thrombosis
- No significant gastrointestinal bleeding in previous 6 months
- No clinically significant hematologic, cardiovascular, neurological, pulmonary, endocrine, gastrointestinal, or genitourinary disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Keating EM, Callaghan JJ, Ranawat AS, Bhirangi K, Ranawat CS. A randomized, parallel-group, open-label trial of recombinant human erythropoietin vs preoperative autologous donation in primary total joint arthroplasty: effect on postoperative vigor and handgrip strength. J Arthroplasty. 2007 Apr;22(3):325-33. doi: 10.1016/j.arth.2006.11.002.
PMID: 17400086RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ortho Biotech, Inc. Clinical Trial
Ortho Biotech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 17, 2006
First Posted
November 22, 2006
Study Start
February 1, 1999
Study Completion
December 1, 2001
Last Updated
April 6, 2010
Record last verified: 2010-04