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Prospective Registry of Anterior Cruciate Ligament Reconstructions

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: NCT04135950
Recruitment Status : Active, not recruiting
First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Leslie Bisson, State University of New York at Buffalo

Tracking Information
First Submitted Date October 21, 2019
First Posted Date October 23, 2019
Last Update Posted Date October 23, 2019
Study Start Date January 2005
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 21, 2019)
additional injury [ Time Frame: intraoperatively ]
At the time of ACL surgery, it is determined if the patient has any other injuries to the meniscus or cartilage.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Registry of Anterior Cruciate Ligament Reconstructions
Official Title Prospective Registry of Predictors and Comorbid Injuries Associated With Anterior Cruciate Ligament Reconstructions
Brief Summary The purpose of the study is to investigate factors that are associated with outcomes of injury to the anterior cruciate ligament (ACL) in the knee among patients who are undergoing surgical reconstruction. This study is a registry of all patients having knee surgery at our institution performed by 4 fellowship-trained orthopaedic surgeons. The surgeon documents patient information on standard data forms including risk factors and surgical findings.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients at our institution who are having ACL surgery by one of 4 fellowship-trained surgeons will be included in this registry.
Condition
  • Anterior Cruciate Ligament Tear
  • Meniscal Tear
  • Cartilage Injury
  • Bone Bruising
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 21, 2019)
900
Original Actual Enrollment Same as current
Estimated Study Completion Date January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients undergoing ACL surgery

Exclusion Criteria:

  • Previous surgery on the affected knee
  • Posterior cruciate ligament injuries
  • Grade 2 lateral collateral ligament or medial collateral ligament injuries
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04135950
Other Study ID Numbers 441874-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Leslie Bisson, State University of New York at Buffalo
Study Sponsor State University of New York at Buffalo
Collaborators Not Provided
Investigators Not Provided
PRS Account State University of New York at Buffalo
Verification Date October 2019