AzTrials
AzTrials

Achilles Tendon RuptureNCT04050748

Achilles Tendon Lengthening With Traditional vs. Accelerated Rehab

A study testing Achilles tendon repair in people with Achilles Tendon Rupture, run by Henry Ford Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Achilles Tendon Rupture
What is being tested?
Achilles tendon repair
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteUnited States
Study dates
1 Jun 2017to 5 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Health Ford Health System

    Detroit, Michigan, 48202

Other trials in United States

About this study

Official title: Comparison of Tendon Lengthening With Traditional vs. Accelerated Rehab Following Achilles Tendon Repair: A Prospective Randomized Controlled Trial

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.

Read the 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.

Being tested
Achilles tendon repair

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Achilles tendon repairProcedure or surgery

    Patients will be undergoing achilles tendon repair

Study groups in NCT04050748
Study groupRoleWhat they receive
Early RehabiliationPlacebo comparator6 weeks of non-weight bearing in addition to basic stretching exercises.
Receives: Procedure: Achilles tendon repair
Accelerated RehabilitationActive comparatorPatients 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
Receives: Procedure: Achilles tendon repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Repair site lengthening

    Intratendinous and repair site lengthening were determined

    Measured: 2 years

Secondary outcomes (1)
  1. Achilles Tendon Total Rupture Score

    measure symptoms and physical activity levels after being treated for a complete Achilles tendon rupture

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2019
  2. Study start1 Jun 2017
  3. Primary completion5 Jun 2019
  4. Study completion5 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04050748
Sponsor's protocol ID
37283847
Status last verified
Aug 2019
First submitted
7 Aug 2019
Last updated
8 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32203675

Questions about this trial

What is this clinical trial studying?

A study testing Achilles tendon repair in people with Achilles Tendon Rupture, run by Henry Ford Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Repair site lengthening (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04050748, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in