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Achilles Tendon Lengthening With Traditional vs. Accelerated Rehab

Primary Purpose

Achilles Tendon Rupture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Achilles tendon repair
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendon Rupture

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Health Ford Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Early Rehabiliation

Accelerated Rehabilitation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Repair site lengthening
Intratendinous and repair site lengthening were determined

Secondary Outcome Measures

Achilles Tendon Total Rupture Score
measure symptoms and physical activity levels after being treated for a complete Achilles tendon rupture

Full Information

First Posted
August 7, 2019
Last Updated
August 7, 2019
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04050748
Brief Title
Achilles Tendon Lengthening With Traditional vs. Accelerated Rehab
Official Title
Comparison of Tendon Lengthening With Traditional vs. Accelerated Rehab Following Achilles Tendon Repair: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 5, 2019 (Actual)
Study Completion Date
June 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
pture of the Achilles tendon is a relatively common injury among athletes involved in sports which require rapid direction changes and accelerations, such as soccer, sprinting, and basketball. Approximately 80% of ruptures occur during recreational sports, but it can also occur in sedentary individuals. An increase in recreational sport involvement has coincided with an increase in Achilles tendon ruptures. The most common age group for this injury is between 30 and 40 years old, and it is more likely to occur in males. It is thought that rupture in this age group is highest due to the co-occurrence of competitive sports and age- related degenerative changes. Tendons changes occur as we age. There is decreased collagen density and fewer cross links, which alters the integrity of the tendon and its sheath. These changes, in addition to repetitive microtrauma, can cause the Achilles tendon to become calcified and thickened. Alteration in the elasticity of the tendon can set the stage for a rupture during abrupt increases in training intensity or during competitions. The Achilles tendon is the largest tendon in the body, and it receives its blood supply from the gastroc- soleus complex. The blood supply is weakest between 2cm and 6cm from the tendon's insertion on the calcaneus, which is also the region where it is most likely to rupture. The current recommendation for acute Achilles rupture is surgical repair, but there is no consensus regarding surgical versus nonsurgical treatment (immobilization, rehab, etc.). Surgical repair is thought to reduce the rates of re-rupture but also cause an increased risk of complications. There does not appear to be a difference in pre-injury activity levels between the two methods. Tendons have excellent healing potential when the torn ends are reasonably approximated. Optimal tendon healing depends on surgical apposition and mechanical stabilization of the tendon ends. Once a tendon has been repaired, the suture material holds the tendon ends together, allowing fibroblasts to produce sufficient amounts of collagen to form a tendon callus. In contrast with approximated tears, neglected ruptures with retraction of the proximal portion of the tendon heal with scar tissue, resulting in a lengthened, weakened musculotendinous unit. Poor muscle function will result without restoration of normal tendon length. Studies of tendon healing have indicated that early controlled motion and tensile stress applied to a repaired tendon promote earlier organization and remodeling of collagen fibers, decreased scar tissue, and increased strength compared with tendon immobilization. Previous studies involving Rotator cuff repairs and ACL ligament reconstructions have employed the use of Tantalum Beads and roentgen stereophotogrammetric analysis to evaluate the creep or stretch of repaired soft tissue. These studies show that there appears to be soft tissue stretch/creep that occurs as tendon and ligament repairs/reconstructions heal. A surgeon's knowledge of how a repaired soft tissue will deform or stretch will be an undoubted asset to patient care and management. This knowledge will be invaluable for the surgeon in regards to appropriately preparing a tendon for repair, directly repairing the tendon and appropriately tensioning of the repair. It will also give valuable information for rehabilitation protocols and activity limitations post-operatively. The safety of tantalum material has well been described in the orthopaedic literature. It is currently used in implants ranging from cervical spinal fusions to femoral rods without side effects. Recently a prospective study looking at creep in rupture biceps tendons has been completed our institution. This study will use stereophotogrammetric analysis to expand our investigations to include Achilles tendon.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Rehabiliation
Arm Type
Placebo Comparator
Arm Description
6 weeks of non-weight bearing in addition to basic stretching exercises.
Arm Title
Accelerated Rehabilitation
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Achilles tendon repair
Intervention Description
Patients will be undergoing achilles tendon repair
Primary Outcome Measure Information:
Title
Repair site lengthening
Description
Intratendinous and repair site lengthening were determined
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Achilles Tendon Total Rupture Score
Description
measure symptoms and physical activity levels after being treated for a complete Achilles tendon rupture
Time Frame
2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Health Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32203675
Citation
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.
Results Reference
derived

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Achilles Tendon Lengthening With Traditional vs. Accelerated Rehab

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