Hip FracturePhase 2NCT00393848
Effectiveness of Two Types of Treatment in Restoring Muscle After Hip or Knee Surgery
A Phase 2 study testing Essential amino acid supplement and Ketoconazole in people with Hip Fracture and Osteoarthritis, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hip Fracture, Osteoarthritis, Femur Head Necrosis
- What is being tested?
- Essential amino acid supplement and Ketoconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Oct 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for surgery because of osteoarthritis, avascular necrosis, fracture, or revision of total joint replacement in the hip or knee
Who cannot join
- 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
- Any other condition or event that would be considered as reason for exclusion by the study investigators
- Pregnancy
- Severe hypertension as indicated by requiring more than two drugs for blood pressure control
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Restoration of Muscle Following Hip Surgery
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.
Read the 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 2.5 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.
- Conditions
- Hip Fracture, Osteoarthritis, Femur Head Necrosis
- Being tested
- Essential amino acid supplement, Ketoconazole, Placebo
- Keywords
- Hip Replacement Arthroplasty, Hip Replacement Surgery, Hip Surgery, Hip Rehabilitation, Avascular Necrosis, Knee replacement surgery, Total knee arthroplasty
- Medical subject headings
- Hip Fractures, Osteoarthritis, Femur Head Necrosis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential amino acid supplementDrug
15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
KetoconazoleDrug
200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
PlaceboDrug
Placebo for Ketoconazole
| Study group | Role | What they receive |
|---|---|---|
| Experiment 2 - Experimental Group | Experimental | Not described Receives: Drug: Ketoconazole |
| Experiment 1 - Standard of care Group | No intervention | Not described |
| Experiment 1 - Experimental Group | Experimental | Not described Receives: Drug: Essential amino acid supplement |
| Experiment 2 - Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Protein Synthesis
Measured: Perioperative and discharge
Secondary outcomes (1)
Change in Maximal Voluntary Contraction
Measured: Baseline and 6 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Arny Ferrando, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393848
- Sponsor's protocol ID
- R01AR052293
- Other IDs
- 70451, 1R01AR052293-01A2
- Status last verified
- May 2014
- First submitted
- 27 Oct 2006
- Last updated
- 2 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Muscle Following Hip Surgery
- ClinicalTrials.gov ID
- NCT00393848
- Acronym / sponsor ID
- R01AR052293
- Conditions
- Hip Fracture, Osteoarthritis, Femur Head Necrosis
- Keywords
- Hip Replacement Arthroplasty, Hip Replacement Surgery, Hip Surgery, Hip Rehabilitation, Avascular Necrosis, Knee replacement surgery, Total knee arthroplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Oct 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 30 Oct 2006 (estimated)
- Results
- Posted 2 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 2.5 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for surgery because of osteoarthritis, avascular necrosis, fracture, or revision of total joint replacement in the hip or knee
Key exclusion criteria (15 listed)
- 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
- Any other condition or event that would be considered as reason for exclusion by the study investigators
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essential amino acid supplement15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge. | Drug | Experiment 1 - Experimental Group |
| Ketoconazole200mg ketoconazole twice daily; started night before surgery and continued through hospitalization. | Drug | Experiment 2 - Experimental Group |
| PlaceboPlacebo for Ketoconazole | Drug | Experiment 2 - Placebo Group |
Primary outcome
Muscle Protein Synthesis
Time frame: Perioperative and discharge
1 secondary outcome
Change in Maximal Voluntary Contraction
Time frame: Baseline and 6 weeks post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arny Ferrando, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Essential amino acid supplement and Ketoconazole in people with Hip Fracture and Osteoarthritis, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Protein Synthesis (time frame: Perioperative and discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2014; AzTrials last refreshed its copy on 8 Nov 2026.