Research

Bone Tunnel Widening Following ACL (Anterior Cruciate Ligament) Reconstruction

IRB Number: 22129
(inactive trial)

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.

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Principal Investigator

Scott Rodeo, MD

Co-Investigators

Russell F. Warren, MD
D. Ross Henshaw, MD
C. Benjamin Ma, MD
Hollis Potter, MD
Robert Schneider, MD
Helene Pavlov, MD

Summary

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.

Inclusion/Exclusion Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

Contact InformationPrincipal Investigator
Scott Rodeo, MD
Tel: 212.606.1513



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