Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393848
Status:
COMPLETED
Last Update Posted:
2014-06-02
First Post:
2006-10-27
Brief Title:
Effectiveness of Two Types of Treatment in Restoring Muscle After Hip or Knee Surgery
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
Restoration of Muscle Following Hip Surgery
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Hip fractures among the elderly are a major health concern Nearly one-third of elderly hip fracture patients die within 1 year of the injury Events surrounding the actual injury and any necessary surgical repair often lead to reduced muscle protein and eventually muscle strength Loss in everyday function and independence may follow especially in elderly or frail individuals The decrease in protein synthesis may be caused by two main events following injury and surgery prolonged inactivity and an increase in stress hormone levels Preventing a loss in protein may help to improve outcomes for individuals undergoing hip surgery and rehabilitation The purpose of this study is to determine the effects of two postoperative interventions designed to retain muscle protein after major hip or knee surgery in adults
This study will include two experiments Experiment 1 will include individuals who are scheduled for hip or knee replacement surgery because of osteoarthritis the need to repair or replace the affected joint or avascular necrosis bone tissue death caused by lack of blood supply Experiment 1 participants will be randomly assigned to one of two groups
Group 1 participants will receive daily supplements of essential amino acids which are thought to stimulate protein synthesis
Group 2 participants will receive standard rehabilitation care while in the hospital and will serve as controls for the effect of time on recovery
Participants will be in the hospital for about 4 days On the morning of surgery blood and urine collection will occur During surgery substances called tracers measuring the extent of protein synthesis and breakdown will be injected into a vein for the first metabolic study Additional blood and muscle samples will also be taken After surgery when participants arrive in the surgical recovery unit and are able to eat they will begin to record all food intake and will receive their assigned treatment Treatment in the form of gel capsules will be taken 25 hours after each meal Urine will be collected throughout hospitalization and blood will be collected each morning Prior to discharge a 24-hour metabolic study will be performed including tracer injections and muscle biopsies After discharge participants will be provided with 6 weeks worth of their assigned treatment Follow-up visits will occur 2 and 6 to 8 weeks after surgery These visits will include various muscle function and physical performance tests Participants will also undergo a dual energy x-ray absorptiometry DEXA scan which will be used to determine muscle mass
Experiment 2 participants will include individuals scheduled for either hip or knee replacement surgery or fracture repair surgery Participants will be randomly assigned to one of two groups
Group 1 participants will receive the antifungal drug ketoconazole which is thought to reduce levels of the stress hormone cortisol
Group 2 participants will receive placebo and standard rehabilitation care while in the hospital
Participants will begin taking their assigned treatments the day prior to surgery those with a hip fracture will take their assigned treatment at least 4 hours prior to surgery The same procedures that occurred in Experiment 1 during surgery and hospitalization will be carried out during Experiment 2 The second metabolic study however will last only 1 hour and will include a standard clinical meal
This study will include two experiments Experiment 1 will include individuals who are scheduled for hip or knee replacement surgery because of osteoarthritis the need to repair or replace the affected joint or avascular necrosis bone tissue death caused by lack of blood supply Experiment 1 participants will be randomly assigned to one of two groups
Group 1 participants will receive daily supplements of essential amino acids which are thought to stimulate protein synthesis
Group 2 participants will receive standard rehabilitation care while in the hospital and will serve as controls for the effect of time on recovery
Participants will be in the hospital for about 4 days On the morning of surgery blood and urine collection will occur During surgery substances called tracers measuring the extent of protein synthesis and breakdown will be injected into a vein for the first metabolic study Additional blood and muscle samples will also be taken After surgery when participants arrive in the surgical recovery unit and are able to eat they will begin to record all food intake and will receive their assigned treatment Treatment in the form of gel capsules will be taken 25 hours after each meal Urine will be collected throughout hospitalization and blood will be collected each morning Prior to discharge a 24-hour metabolic study will be performed including tracer injections and muscle biopsies After discharge participants will be provided with 6 weeks worth of their assigned treatment Follow-up visits will occur 2 and 6 to 8 weeks after surgery These visits will include various muscle function and physical performance tests Participants will also undergo a dual energy x-ray absorptiometry DEXA scan which will be used to determine muscle mass
Experiment 2 participants will include individuals scheduled for either hip or knee replacement surgery or fracture repair surgery Participants will be randomly assigned to one of two groups
Group 1 participants will receive the antifungal drug ketoconazole which is thought to reduce levels of the stress hormone cortisol
Group 2 participants will receive placebo and standard rehabilitation care while in the hospital
Participants will begin taking their assigned treatments the day prior to surgery those with a hip fracture will take their assigned treatment at least 4 hours prior to surgery The same procedures that occurred in Experiment 1 during surgery and hospitalization will be carried out during Experiment 2 The second metabolic study however will last only 1 hour and will include a standard clinical meal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AR052293-01A2 | NIH | None | httpsreporternihgovquickSearch1R01AR052293-01A2 |
| 70451 | None | None | None |