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Achilles Tendon Lengthening With Traditional vs. Accelerated Rehab

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ClinicalTrials.gov Identifier: NCT04050748
Recruitment Status : Completed
First Posted : August 8, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Toufic R. Jildeh, Henry Ford Health System

Brief Summary:
The purpose of this study is to evaluate the surgically repaired tendon of a ruptured achilles tendon. We will investigate fixation slippage and tendon creep and correlate how these post-repair findings can contribute to outcomes of tendon repairs.

Condition or disease Intervention/treatment Phase
Achilles Tendon Rupture Procedure: Achilles tendon repair Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Tendon Lengthening With Traditional vs. Accelerated Rehab Following Achilles Tendon Repair: A Prospective Randomized Controlled Trial
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : June 5, 2019
Actual Study Completion Date : June 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation Tears

Arm Intervention/treatment
Placebo Comparator: Early Rehabiliation
6 weeks of non-weight bearing in addition to basic stretching exercises.
Procedure: Achilles tendon repair
Patients will be undergoing achilles tendon repair

Active Comparator: Accelerated Rehabilitation
Patients will be non-weight bearing for 2 weeks. After 2 weeks patients were transitioned to a boot with two heel wedges and were weight bearing as tolerated. At 4 weeks, patients were transitioned to one wedge, and at 6 weeks patients were weight bearing as tolerated in a flat shoe. Each heel wedge was ¾ inch tall. After 6 weeks, patient's in both groups underwent identical rehab regimens per protocol
Procedure: Achilles tendon repair
Patients will be undergoing achilles tendon repair




Primary Outcome Measures :
  1. Repair site lengthening [ Time Frame: 2 years ]
    Intratendinous and repair site lengthening were determined


Secondary Outcome Measures :
  1. Achilles Tendon Total Rupture Score [ Time Frame: 2 years ]
    measure symptoms and physical activity levels after being treated for a complete Achilles tendon rupture



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Patients with an acute tendon rupture less than 6 weeks were included in this study.

Exclusion Criteria:

- Underwent any additional concomitant procedures or tendon transfers, sustained prior ruptures, or had a chronic rupture.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050748


Locations
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United States, Michigan
Health Ford Health System
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System

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Responsible Party: Toufic R. Jildeh, Principal Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT04050748     History of Changes
Other Study ID Numbers: 37283847
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries