Institutional Review Board, Hospital for Special Surgery
July 06, 2005
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.
This will be a prospective study for patients undergoing ACL reconstruction using bone-patella-tendon-bone graft, hamstring graft or achilles allograft. Each group will have ACL reconstruction with fixation using bioabsorbable interference screws on the femoral and tibial side. Patients will be evaluated on the day of surgery, 6, 12, 24, 52 and 104 weeks post-operatively. Evaluations will include pre-operative regional and standard bone mineral density measurements, post-operative MRI evaluation of tunnel dimensions and bone-tendon interface, radiographic evaluation of tunnel dimensions and routine clinical follow-up. Twenty patients will be enrolled in each group.
Individuals within the age of 18 to 55 who are diagnosed with anterior cruciate insufficiency and have decided to undergo ACL reconstruction using autogenous graft will be included in the study.
Individuals that have previous knee surgeries, multi-ligament injuries, systemic ligament disorders such as Ehlos Danlos syndrome or connective tissue disorders will be excluded from the study. Individuals who are pregnant or expect to be pregnant during the course of the study or who are especially concerned with X-ray exposure should also be excluded.
Contact Information Principal Investigator
Scott Rodeo, MD