NCT00393848

Brief Summary

The purpose of this study is to determine the effects of two postoperative interventions designed to preserve muscle protein after major hip or knee surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_2

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

October 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2006

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

June 2, 2014

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

Enrollment Period

6 years

First QC Date

October 27, 2006

Results QC Date

January 6, 2014

Last Update Submit

May 30, 2014

Conditions

Hip FractureOsteoarthritisFemur Head Necrosis

Keywords

Hip Replacement ArthroplastyHip Replacement SurgeryHip SurgeryHip RehabilitationAvascular NecrosisKnee replacement surgeryTotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Muscle Protein Synthesis

    Perioperative and discharge

Secondary Outcomes (1)

  • Change in Maximal Voluntary Contraction

    Baseline and 6 weeks post surgery

Study Arms (4)

Experiment 2 - Experimental Group

EXPERIMENTAL
Drug: Ketoconazole

Experiment 1 - Standard of care Group

NO INTERVENTION

Experiment 1 - Experimental Group

EXPERIMENTAL
Drug: Essential amino acid supplement

Experiment 2 - Placebo Group

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Essential amino acid supplementDRUG

15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.

Experiment 1 - Experimental Group
KetoconazoleDRUG

200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.

Experiment 2 - Experimental Group
PlaceboDRUG

Placebo for Ketoconazole

Experiment 2 - Placebo Group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for surgery because of osteoarthritis, avascular necrosis, fracture, or revision of total joint replacement in the hip or knee

You may not qualify if:

  • Taking insulin, thiazolidinediones (TZD), or metformin
  • Kidney insufficiency, as indicated by serum creatinine of more than 2.0 mg/dl
  • Recently treated cancer other than basal cell carcinoma
  • Pregnancy
  • Severe hypertension as indicated by requiring more than two drugs for blood pressure control
  • History of hypo- or hypercoagulation disorders, including individuals who have taken warfarin (Coumadin)
  • Atrial fibrillation, angina, or congestive heart failure
  • Liver disease or abnormal liver function tests
  • HIV infected
  • Active hepatitis
  • Any uncontrolled metabolic disease, including liver or kidney disease
  • Taking medications that use the cytochrome P450 pathway for metabolism and unable to discontinue their use for the duration of the study
  • Require certain medications. More information on this criterion can be found in the protocol.
  • Gastrointestinal absorption disorders that affect nutrient uptake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Hip FracturesOsteoarthritisFemur Head NecrosisOsteonecrosis

Interventions

Ketoconazole

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Arny Ferrando
Organization
UAMS
aferrando@uams.edu
501-526-5711

Study Officials

  • Arny Ferrando, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2006

First Posted

October 30, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

June 2, 2014

Results First Posted

June 2, 2014

Record last verified: 2014-05

Locations

US(1)