Effectiveness of Two Types of Treatment in Restoring Muscle After Hip or Knee Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00393848
First received: October 27, 2006
Last updated: May 30, 2014
Last verified: May 2014
Results First Received: January 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Conditions: Hip Fracture
Osteoarthritis
Femur Head Necrosis
Interventions: Drug: Essential amino acid supplement
Drug: Ketoconazole
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Experiment 1 - Amino Acid Supplement Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
Experiment 1 - Standard of Care Usual clinical care with no dietary intervention.
Experiment 2 - Ketoconazole 200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
Experiment 2 - Placebo Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.

Participant Flow:   Overall Study
    Experiment 1 - Amino Acid Supplement     Experiment 1 - Standard of Care     Experiment 2 - Ketoconazole     Experiment 2 - Placebo  
STARTED     16     9     6     9  
COMPLETED     16     9     4     8  
NOT COMPLETED     0     0     2     1  
Surgical schedule                 0                 0                 0                 1  
Personal reasons                 0                 0                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Experiment 1 - Amino Acid Supplement Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
Experiment 1 - Standard of Care Usual clinical care - no dietary intervention.
Experiment 2 - Ketoconazole 200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
Experiment 2 - Placebo Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
Total Total of all reporting groups

Baseline Measures
    Experiment 1 - Amino Acid Supplement     Experiment 1 - Standard of Care     Experiment 2 - Ketoconazole     Experiment 2 - Placebo     Total  
Number of Participants  
[units: participants]
  16     9     4     8     37  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     13     7     4     7     31  
>=65 years     3     2     0     1     6  
Age  
[units: years]
Mean ± Standard Deviation
  55  ± 7     56  ± 8     44  ± 15     46  ± 15     51  ± 11  
Gender  
[units: participants]
         
Female     7     3     2     2     14  
Male     9     6     2     6     23  
Region of Enrollment  
[units: participants]
         
United States     16     9     4     8     37  



  Outcome Measures
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1.  Primary:   Muscle Protein Synthesis   [ Time Frame: Perioperative and discharge ]

2.  Secondary:   Change in Maximal Voluntary Contraction   [ Time Frame: Baseline and 6 weeks post surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Arny Ferrando
Organization: UAMS
phone: 501-526-5711
e-mail: aferrando@uams.edu


No publications provided


Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00393848     History of Changes
Other Study ID Numbers: R01 AR052293, 70451, 1R01AR052293-01A2
Study First Received: October 27, 2006
Results First Received: January 6, 2014
Last Updated: May 30, 2014
Health Authority: United States: Federal Government