NCT00962143

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

2.5 years

First QC Date

August 17, 2009

Last Update Submit

April 4, 2017

Conditions

Achilles Tendon Tear

Keywords

Acute Achilles Tendon TearAcute Achilles Tendon Repair

Outcome Measures

Primary Outcomes (3)

  • Improvement in ROM and Biodex Isokinetic Strength Testing compared to contralateral limb

    2, 3, 4.5, 6, and 12 months

  • Time to return to weight bearing

    2, 3, 4.5, 6, and 12 months

  • Time to return to full activity

    2, 3, 4.5, 6, and 12 months

Secondary Outcomes (3)

  • Swelling, stiffness, pain, disease specific quality of life: SF-36, AOFAS Hindfoot scores

    6 weeks, 2, 3, 4.5, 6 and 12 months

  • Complication rate including re-rupture and incision wound healing delay

    6 weeks, 2, 3, 4.5, 6 and 12 months

  • Incidence of device and procedure-related adverse events

    6 weeks, 2, 3, 4.5, 6 and 12 months

Study Arms (2)

Achilles repair without OrthADAPT Augmentation

ACTIVE COMPARATOR

Achilles repair without OrthADAPT Augmentation

Procedure: Achilles repair without OrthADAPT Augmentation

Achilles repair with OrthADAPT augmentation

EXPERIMENTAL

Achilles repair with OrthADAPT augmentation

Device: Achilles repair with OrthADAPT augmentation

Interventions

Achilles repair with OrthADAPT augmentationDEVICE

Achilles repair with OrthADAPT augmentation

Achilles repair with OrthADAPT augmentation
Achilles repair without OrthADAPT AugmentationPROCEDURE

Achilles repair without OrthADAPT Augmentation

Achilles repair without OrthADAPT Augmentation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A transverse, full thickness, acute mid-substance Achilles tendon tear that requires surgical repair
  • Achilles tendon tear is repairable by surgery using primary means as determined by intra-operative assessment
  • Achilles tendon rupture with viable ends of the tendon that are suitable for primary repair
  • Isolated Achilles tendon rupture without poly trauma
  • Patient must be 18 to 70 years of age
  • Life expectancy greater than or equal to 12 months
  • Patient is able to provide voluntary informed consent
  • Patient is willing and able to return for all follow-up visits and study related exams
  • Patient is willing to comply with prescribed physical therapy regimen

You may not qualify if:

  • Emergency, poly trauma patients
  • Previous Achilles tendon surgical procedure on that tendon
  • Deficit in the contralateral extremity that prevents a comparison with the treated extremity
  • Repair requires tendon lengthening, gap filling or tendon transfer
  • BMI greater than 40
  • Peripheral arterial disease
  • Uncontrolled Diabetes Mellitis
  • Patients whose injury is known to involve litigation
  • Known allergy to equine derived product
  • Systemic collagen disease
  • Neurological disease
  • Active infection - systemic or at the intended surgical site
  • Acute use of immunosuppressive agents
  • Rupture resulting from fluoroquinolone induced tendinopathy
  • Alcohol or drug abuse
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Institute of Central Jersey

Sea Girt, New Jersey, 08750, United States

Location

Study Officials

  • Daniel Lee, DPM

    Department of Orthopaedic Surgery, UCSD

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 19, 2009

Study Start

June 1, 2008

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

April 5, 2017

Record last verified: 2017-04

Locations

US(1)