Bone Tunnel Widening Following ACL Reconstruction

This study is currently recruiting participants.

Verified by Hospital for Special Surgery, New York, December 2006

Sponsors and Collaborators:	Hospital for Special Surgery, New York Inion Oy
Information provided by:	Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:	NCT00198042

Purpose

Hypothesis 1: There is less tunnel-widening with bone–patella tendon–bone graft compared with the hamstring graft when the same fixation method is used. Tunnel widening is greater with achilles tendon allografts versus autograft bone-patella tendon-bone and hamstring autografts.

Hypothesis 2: Tunnel widening occurs in the early post-operative period (< 8 weeks) when the tendon remodels within the bone tunnels.

Hypothesis 3: Low pre-operative bone mineral density is associated with tunnel widening.

Condition	Intervention	Phase
Anterior Cruciate Ligament Injury Knee Injuries	Procedure: Surgical reconstruction of the ACL	Phase I

MedlinePlus related topics: Knee Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Bone Tunnel Widening Following ACL Reconstruction

Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:

Bone tunnel diameter/area

Secondary Outcome Measures:

Knee stability

Estimated Enrollment:	40
Study Start Date:	June 2004
Estimated Study Completion Date:	December 2008

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Individuals within the age range of 18 to 55 years 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 Ehlers 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198042

Contacts

Contact: Scott Rodeo, MD

212-606-1513

rodeos@hss.edu

Locations

United States, New York
Hospital for Special Surgery	Recruiting
New York, New York, United States, 10021
Contact: Scott Rodeo, MD 212-606-1513 rodeos@hss.edu

Sponsors and Collaborators

Hospital for Special Surgery, New York

Inion Oy

Investigators

Principal Investigator:

Scott Rodeo, MD

Hospital for Special Surgery

More Information

Study ID Numbers:	22129
Study First Received:	September 13, 2005
Last Updated:	June 20, 2007
ClinicalTrials.gov Identifier:	NCT00198042
Health Authority:	United States: Institutional Review Board

Keywords provided by Hospital for Special Surgery, New York:

ACL
Tunnel
Widening

Study placed in the following topic categories:

Wounds and Injuries
Disorders of Environmental Origin
Knee Injuries
Leg Injuries

ClinicalTrials.gov processed this record on January 15, 2009