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Acute Achilles Repair With or Without OrthADAPT Augmentation

NCT00962143 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-04-05

No results posted yet for this study

Summary

The purpose of this study is to assess the clinical performance of the OrthADAPT Bioimplant in patients with acute mid-substance Achilles tendon tears requiring surgical repair.

Conditions

  • Achilles Tendon Tear

Interventions

DEVICE

Achilles repair with OrthADAPT augmentation

Achilles repair with OrthADAPT augmentation

PROCEDURE

Achilles repair without OrthADAPT Augmentation

Achilles repair without OrthADAPT Augmentation

Sponsors & Collaborators

  • Synovis Surgical Innovations

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • Daniel Lee, DPM · Department of Orthopaedic Surgery, UCSD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-12-31
Completion
2011-01-31

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 NCT00962143 on ClinicalTrials.gov