Bone Tunnel Widening Following ACL Reconstruction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Hospital for Special Surgery, New York.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Inion Oy
Information provided by:
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00198042
First received: September 13, 2005
Last updated: June 20, 2007
Last verified: December 2006
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bone Tunnel Widening Following ACL Reconstruction

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, New York
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Knee Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 20, 2014