Institutional Review Board, Hospital for Special Surgery
March 19, 2008
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
18 patients undergoing ACL allograft reconstruction will be randomized into two groups of 9. One group will have a femoral nerve block (FNB) administered pre-operatively. The other group will not have a FNB administered. Both procedures are considered standard of care. The primary outcome is whether the patients who receive a FNB will have fine needle EMG scores that differ from those who do not receive the FNB. This is to determine if there is any risk of strength loss associated with the commonly used FNB. All patients will be seen pre-operatively, at the first post operative visit, and 6 weeks post-operatively. The enrollment period will remain open until the patient number is reached.
Patients (ages 18 to 65) of the PI and co-investigators who plan to undergo allograft ACL reconstruction at Hospital for Special Surgery with or without a meniscectomy. Those who plan to undergo allograft ACL reconstructions with a meniscectomy are included because the post-operative recovery is the same as those with a pure achilles tendon allograft ACL Reconstruction.
• Patients with concomitant injuries who undergo procedures other than a meniscectomy and those who have BTB or hamstring ACL reconstructions. The post-operative recovery in these patients is different from those who undergo a pure allograft ACL Reconstruction.
• Patients with a history of femoral neuropathy, a lumbar plexopathy or peripheral polyneuropathy
• Patients who have been diagnosed with an ACL injury greater than 8 weeks prior to surgery.
• Patients who have a history of previous knee surgery on the affected knee.
Greg Fives, PT