Transphyseal Vs. Physeal Sparing ACL Reconstruction in Skeletally Immature Patients: Risk of Subsequent Lower Extremity Growth Deformity

NCT03081026 | Completed

• 1 other identifier: Pro00063612
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the risk of lower extremity angular growth deformity following anterior cruciate ligament (ACL) reconstructions in young patients who are not yet skeletally mature. The study will compare two surgical techniques (physeal sparing vs transphyseal).

Conditions

ACL Reconstruction

Keywords

surgery; ages 6-16

Outcome Measures

Primary Outcomes (2)

• Limb length discrepancy

  Bilateral hip to ankle radiographs measurements.

  Clinic visit, approximately 1 hour

• Limb Angular alignment

  Bilateral hip to ankle radiographs measurements

  Clinic visit, approximately 1 hour

Secondary Outcomes (1)

• Range of motion measurements

  Clinic visit, approximately 1 hour

Other Outcomes (1)

• Patient Reported Outcomes surveys

  Clinic visit, approximately 1 hour

Study Arms (3)

Ages less than 12

Those having ACL Reconstruction surgery during the desired dates at age 12 or less.

Diagnostic Test: Bilateral hip to ankle x-ray, exam and strength testing.

Ages 12-13

Those having ACL Reconstruction surgery during the desired dates at ages 12 and 13.

Diagnostic Test: Bilateral hip to ankle x-ray, exam and strength testing.

Ages 14 - 16

Those having ACL Reconstruction surgery during the desired dates at ages 14 - 16.

Diagnostic Test: Bilateral hip to ankle x-ray, exam and strength testing.

Interventions

Bilateral hip to ankle x-ray, exam and strength testing. DIAGNOSTIC_TEST

Only an X-Ray is performed and reviewed to identify any growth disturbances.

Ages 12-13; Ages 14 - 16; Ages less than 12

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Single site patients of five orthopaedic sports medicine attendings who had an ACL reconstruction between the ages of 6-16 with open physes in the time interval from January 1, 2005-December 31, 2016.

You may not qualify if:

• Pregnant Females

Sponsors & Collaborators

• Duke University: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (1)

Duke Sports Science Institute

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Interventions

Physical Examination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Dean C Taylor, MD

  Duke Sports Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 15, 2017
• Study Start: May 1, 2017
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)