Bone Tunnel Widening Following ACL Reconstruction
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2015
CompletedResults Posted
Study results publicly available
May 17, 2017
CompletedMay 17, 2017
May 1, 2017
11.6 years
September 13, 2005
March 20, 2017
May 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone Tunnel Diameter
Bone tunnel diameter measured on MRI
2 years
Other Outcomes (1)
Bone Tunnel Cross Sectional Area
2 years
Study Arms (1)
Surgical Reconstruction of the ACL
EXPERIMENTALInterventions
Surgical reconstruction of the ACL
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital for Special Surgery, New Yorklead
- Inion Oycollaborator
Study Sites (1)
Hospital for Special Surgery
New York, New York, 10021, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Scott Rodeo, MD
- Organization
- Hospital for Special Surgery
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Rodeo, MD
Hospital for Special Surgery, New York
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
June 1, 2004
Primary Completion
December 31, 2015
Study Completion
December 31, 2015
Last Updated
May 17, 2017
Results First Posted
May 17, 2017
Record last verified: 2017-05