CompletedPhase 4

The Effect of PROCRIT (Epoetin Alfa) on Postoperative Vigor and Handgrip Strength (VIGOR Study)

289 participantsStarted 1999-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

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.

Trial details

NCT IDNCT00401869

SponsorOrtho Biotech, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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