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Prospective Evaluation of Osseous Integration in ACL Reconstruction Comparing Tightrope vs Interference Screw Fixation

NCT03841500 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2019-02-15

No results posted yet for this study

Summary

The purpose of our study was to compare osseous integration of the bone block in Achilles tendon allograft ACL reconstruction using a cortical button versus biocomposite interference screw fixation. The primary outcome was bone block incorporation within the femoral tunnel at six months. Our null hypothesis was that there is no difference in osseous incorporation or outcome with either type of femoral fixation in primary ACL reconstruction with Achilles tendon allograft. Our secondary outcomes were pain and clinical outcome scores between the two groups.

Conditions

  • ACL - Anterior Cruciate Ligament Rupture

Interventions

DEVICE

Biocomposite intereference screw femoral tunnel fixation

ACL reconstruction using biocomposite intereference screw for femoral tunnel fixation

DEVICE

Endobutton (Tightrope) femoral tunnel fixation

ACL reconstruction using endobutton (Tightrope) for femoral tunnel fixation

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • Kelsey-Seybold Clinic

    lead OTHER

Principal Investigators

  • Anup Shah · Kelsey-Seybold Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-01-31
Completion
2017-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03841500 on ClinicalTrials.gov