NCT04050748

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

August 7, 2019

Last Update Submit

August 7, 2019

Conditions

Achilles Tendon Rupture

Outcome Measures

Primary Outcomes (1)

  • Repair site lengthening

    Intratendinous and repair site lengthening were determined

    2 years

Secondary Outcomes (1)

  • Achilles Tendon Total Rupture Score

    2 years

Study Arms (2)

Early Rehabiliation

PLACEBO COMPARATOR

6 weeks of non-weight bearing in addition to basic stretching exercises.

Procedure: Achilles tendon repair

Accelerated Rehabilitation

ACTIVE COMPARATOR

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

Interventions

Achilles tendon repairPROCEDURE

Patients will be undergoing achilles tendon repair

Accelerated RehabilitationEarly Rehabiliation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

  • Okoroha KR, Ussef N, Jildeh TR, Khalil LS, Hasan L, Bench C, Zeni F, Eller E, Moutzouros V. Comparison of Tendon Lengthening With Traditional Versus Accelerated Rehabilitation After Achilles Tendon Repair: A Prospective Randomized Controlled Trial. Am J Sports Med. 2020 Jun;48(7):1720-1726. doi: 10.1177/0363546520909389. Epub 2020 Mar 23.

    PMID: 32203675DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 8, 2019

Study Start

June 1, 2017

Primary Completion

June 5, 2019

Study Completion

June 5, 2019

Last Updated

August 8, 2019

Record last verified: 2019-08

Locations

US(1)