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Bone Tunnel Widening Following ACL Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00198042
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Anterior Cruciate Ligament Injury Knee Injuries Procedure: Surgical reconstruction of the ACL

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bone Tunnel Widening Following ACL Reconstruction
Study Start Date : June 2004
Primary Completion Date : December 31, 2015
Study Completion Date : December 31, 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Surgical Reconstruction of the ACL Procedure: Surgical reconstruction of the ACL
Surgical reconstruction of the ACL


Outcome Measures

Primary Outcome Measures :
  1. Bone Tunnel Diameter [ Time Frame: 2 years ]
    Bone tunnel diameter measured on MRI


Other Outcome Measures:
  1. Bone Tunnel Cross Sectional Area [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198042


Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Inion Oy
Investigators
Principal Investigator: Scott Rodeo, MD Hospital for Special Surgery, New York
More Information

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00198042     History of Changes
Other Study ID Numbers: 22129
First Posted: September 20, 2005    Key Record Dates
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Hospital for Special Surgery, New York:
ACL
Tunnel
Widening

Additional relevant MeSH terms:
Wounds and Injuries
Knee Injuries
Anterior Cruciate Ligament Injuries
Leg Injuries