Achilles Tendon Lengthening With Traditional vs. Accelerated Rehab

NCT ID: NCT04050748

Last Updated: 2019-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2019-06-05

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.

Conditions

Achilles Tendon Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early Rehabiliation

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

Group Type: PLACEBO_COMPARATOR

Achilles tendon repair

Intervention Type: PROCEDURE

Patients will be undergoing achilles tendon repair

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

Group Type: ACTIVE_COMPARATOR

Achilles tendon repair

Intervention Type: PROCEDURE

Patients will be undergoing achilles tendon repair

Interventions

Achilles tendon repair

Patients will be undergoing achilles tendon repair

Intervention Type: PROCEDURE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Toufic R. Jildeh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Health Ford Health System

Detroit, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32203675 (View on PubMed)

Other Identifiers

37283847

Identifier Type: -

Identifier Source: org_study_id