The control group will have a joint aspiration performed at an initial visit (within the first 10 days after injury), and at the time of surgery (within 4 weeks of injury).

The experimental group will have a joint aspiration performed at an initial visit (within the first 10 days after injury) and receive an injection of leukocyte poor platelet rich plasma injection in their knee. At a second visit 5-12 days after the initial visit, the patient will receive a joint aspiration and platelet rich plasma injection. A final joint aspiration will be performed at the time of surgery (within 4 weeks of injury).

Anterior Cruciate Ligament Tear

Anterior Cruciate Ligament Rupture

Patients will receive platelet rich plasma injection two times prior to surgery.

Experimental Group

Patients will have their knee aspirated at their initial physician visit and at the time of surgery.

Control Group

Andrews Institute for Orthopaedics & Sports Medicine

Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears

Effect of Platelet Rich Plasma Injections on Inflammatory and Chondrodegenerative Biomarkers in Patients With Acute Anterior Cruciate Ligament Tears

The presence of this biomarker in the synovial fluid will be assessed.

This survey assess knee function, symptoms, and sports activities. The scale scores range from 0-100 with a score of 100 indicating no functional limitations or symptoms.

This survey assess knee pain and function. The scale scores range from 100 (no symptoms) to zero (extreme symptoms).

Andrews Research & Education Foundation

Subjects who are to undergo primary total knee arthroplasty due to primary OA which may include but is not limited to bilateral or peripheral involvement with no significant history of overuse or trauma to the joint.

Subjects who are to undergo primary total knee arthroplasty due to osteoarthritis of the knee that is secondary to injury or overuse of the joint.

1. 2cc whole blood to be collected from patient on date of total knee arthroplasty 2. Joint aspirate harvested and collected intraoperatively during total knee arhtroplasty

Osteoarthritis of the Knee

Blood drawn for A2M levels to be assayed at Cytonics

Blood Draw

Joint aspirate harvested for A2M levels to be assayed at Cytonics

Joint Aspirate Harvest

Stanford University Hospital

Serum and Synovium Protease Inhibitor Levels in Primary and Secondary Osteoarthritic Joints

Evaluation of Serum and Synovium Protease Inhibitor Levels in Primary and Secondary Osteoarthritic Joints, and Comparison for Patients Undergoing Joint Replacement

A2M levels will be drawn from plasma and synovium on the date of surgery for total knee arthroplasty. samples will then be stored properly and analyzed once data collection is complete.

Scuderi, Gaetano J., M.D.

Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.

Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.

Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 11 feet of sea water (fsw) or 1.3 ATA. The chamber pressure was slowly decreased over 10 minutes to 6 fsw (1.2 ATA). The final depressurization to surface was done over a 10 minute period. To simulate the treatment 2.4 ATA pressurization, pressurizations and depressurizations were done using venting techniques that would be nearly identical with the noise and temperature as that experienced with the treatment leg. The inside observers simulated pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness)at the same frequency as if they were in the treatment exposure pressure.

Sham Treatment

Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 45 feet of sea water (fsw) or 2.4 ATA. The final depressurization to surface was done over a 10 minute period. Inside observers used pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) three times (10/15/5 minute durations)during the exposure.

Hyperbaric Oxygen 2.4 ATA

Total

Sex: Female, Male

Region of Enrollment

The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The verbal memory score demonstrates improvement as the score increases. The score range was 36.8 to 98.6.

Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment

Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.

Computer Cognitive Test Scores - ImPACT Verbal Memory

The PCL-M is a self reported test in which a list of 17 problems and complaints are offered to the individual to score on a 1 to 5 scale with 1 designating "not at all", 2= "a little bit", 3= "moderately", 4= "quite a bit" and 5 designating "extremely". A sample complaint would be "repeated, disturbing dreams of a stressful military experience". Hence there is a possible total score range from 17 to 85. For military members, a score of 50 or above is indicative of PTSD. A change from baseline of 5-9 represents a reliable change and change of 10 or greater is a significant change.

Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 11 feet of sea water (fsw) or 1.3 ATA. The chamber pressure was slowly decreased over 10 minutes to 6 fsw (1.2 ATA). The final depressurization to surface was done over a 10 minute period. To simulate the treatment 2.4 ATA pressurization, pressurizations and depressurizations were done using venting techniques that would be nearly identical with the noise and temperature as that experienced with the treatment pressure. The inside observers simulated pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) at the same frequency as if they were in the treatment exposure pressure.

Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 45 feet of sea water (fsw) or 2.4 ATA. The final depressurization to surface was done over a 10 minute period. Inside observers used pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) three times (10/15/5 minute durations) during the exposure.

Posttraumatic Stress Disorder Checklist - Military Version (PCL-M) Scores

The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The visual memory score demonstrates improvement as the score increases. The score range was 31.2 to 92.7.

Computer Cognitive Test Scores - ImPACT Visual Memory

The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The Processing Speed score demonstrates improvement as the score increases. The score range was 9.7 to 52.4.

Computer Cognitive Test Scores - ImPACT Processing Speed

The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The reaction time score demonstrates improvement as the score decreases. The score range was 0.42 to 1.84.

Computer Cognitive Test Scores - ImPACT Reaction Time

Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The simple reaction time range is 30 to 255.

Computer Cognitive Test Scores - BrainCheckers Simple Reaction Time

Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 9 to 66. The scores in this section represent results of the code substitution subtest.

Computer Cognitive Test Scores - BrainCheckers Code Substitution

Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 25 to 118. The scores in this section represent results of the procedural reaction time.

Computer Cognitive Test Scores - BrainCheckers Procedural Reaction Time

Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 41 to 174. The scores in this section represent results of the Go-NoGo reaction time subtest.

Computer Cognitive Test Scores - BrainCheckers Go-NoGo Reaction Time

BrainCheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate accuracy in each of the subtest. The range is 6 to 50. The scores in this section represent results of the matching to sample subtest.

Computer Cognitive Test Scores - BrainCheckers Matching To Sample

BrainCheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate accuracy in each of the subtest. The range is 6 to 135. The scores in this section represent results of the code sub recall subtest.

Computer Cognitive Test Scores - BrainCheckers Code Sub Recall

Functional MRI

A non-parametric regression 14 using the Theil estimator was fit to the observed data in order to demonstrate general trends for relations between measures of cognitive functioning and increased stem cells.

Stem Cells: CD_34

The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated against the concussion history items. Main categories were the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. A concussive event was defined as one immediately followed with symptoms. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in the individuals who experienced only one concussive event.

Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.

Sham Treatment Improved

Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.

Sham Treatment Not Improved

Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.

Hyperbaric Oxygen 2.4 ATA Improved

Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.

Hyperbaric Oxygen 2.4 ATA Not Improved

PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Only One Concussive Event

The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated against the concussion history items. Main categories were the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. A concussive event was defined as one immediately followed with symptoms. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in individuals who experienced two concussive events.

PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Two Concussive Events

The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated against the concussion history items. Main categories were the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. A concussive event was defined as one immediately followed with symptoms. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in individuals who experienced three concussive events.

PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Three Concussive Events

The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated against the concussion history items. Main categories were the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. A concussive event was defined as one immediately followed with symptoms. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in individuals who experienced four or more concussive events.

PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Four or More Concussive Events

The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated for the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. Many subjects had multiple blast and/or impact events without a concussion (asymptomatic), but had a flight or flight (danger response) experience. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in individuals who experienced multiple non-concussive blast and/or impact events.

Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement from baseline at 30 post hyperbaric exposure or 6 week follow-up.

Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by 9 or less)improvement from baseline at 30 post hyperbaric exposure or 6 week follow-up.

Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement from baseline at 30 post hyperbaric exposure or 6 week follow-up.

Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by 9 or less)improvement from baseline at 30 post hyperbaric exposure or 6 week follow-up.

PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Multiple Non-concussive Blast and/or Impact Exposures.

The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated for the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) with consent within one year from the last concussion in subjects who had multiple concussions.

Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 9 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.

Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 9 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.

PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, Measuring Time to Consent From the Last Concussion in Subjects With Multiple Concussions.

Overall Study

Dr. George Wolf, Associate Investigator

Brain Injury, Chronic

Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.

Hyperbaric oxygen @ 2.4 ATA

Sham treatment

Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy

Treatment of Moderate to Mild Cognitive Dysfunction Caused by Traumatic Brain Injury (TBI) With Hyperbaric Oxygen Therapy (HBOT)

George Wolf

Study Director

San Antonio Military Medical Center

The treatment group, comprised of ten patients, will receive an intravenous dose of 200 mcg (1 ml) of darbepoetin (Aranesp®). Patients will be randomly assigned to either the treatment group, or the control group in a 2:1 ratio. The treatment group will be given 200 mcg of darbepoetin intravenously. The control group will be given a matching placebo of 1 mL of normal saline.

Traumatic Brain Injury

Darbeopoetin

Normal Saline (Placebo)

Royal Alexandra Hospital

University of Alberta Hospital

Safety of Darbepoetin Alfa Treatment in Patients With Severe Traumatic Brain Injury

A Prospective Randomized Placebo Controlled Study of the Efficacy and Safety of Darbepoetin Alfa Treatment in Patients With Severe Traumatic Brain Injury

The primary outcome measures include Neuron-specific serum enolase, CSF glutamate and CSF S100B levels in patients receiving darbepoetin compared to placebo over a 96 hour period and ICP levels in patients receiving darbepoetin compared to placebo over a 96 hour period

post-traumatic stress disorder/protease

Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears

Serum and Synovium Protease Inhibitor Levels in Primary and Secondary Osteoarthritic Joints

Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy

Safety of Darbepoetin Alfa Treatment in Patients With Severe Traumatic Brain Injury

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