Clinical Outcome of Achilles Tendon Repair Using Viable Intact Cryopreserved Umbilical Tissue Versus Standard of Case

Introduction. Repair of acute Achilles tendon ruptures is complicated by the severity of the rupture, quality of the tendon, and length of the defect. The adjunct use of biologics (eg, viable umbilical tissue) may provide additional support and reduce postoperative inflammation, adhesions, and fibrosis. Objective. The aim of this study is to review the outcomes of Achilles tendon rupture open repairs with viable cryopreserved umbilical tissue (vCUT) compared with patients treated with standard of care only. Materials and Methods. Four patients (average age, 59 years; range, 55-65 years; 2 male, 2 female) with acute Achilles tendon injuries treated surgically with vCUT were selected. The repairs were augmented with vCUT sutured over the tendon ends (Wharton’s jelly side towards the tendon) with absorbable sutures. Results. Patients remained nonweight-bearing after surgery for 4 to 6 weeks followed by a gradual return to ambulation. All patients maintained durable skin closure, had minimal scarring and edema, and were able to return to work in 8 to 10 weeks. All 4 patients returned to their preinjury activity level without pain or loss of function. There were no vCUT-related complications or adverse events. Conclusions. Clinical outcomes of this study support the use of vCUT for augmentation of Achilles tendon repair. 

Repair of acute Achilles tendon ruptures is complicated by the severity of the rupture, quality of the tendon, and length of the defect. The adjunct use of biologics, such as viable umbilical tissue, aims to provide additional support and reduce postoperative inflammation, adhesion, and fibrosis.^1-3 Viable cryopreserved umbilical tissue (vCUT; Stravix, Osiris Therapeutics, Inc, Columbia, MD) is composed of umbilical amnion and Wharton’s jelly, and it has anti-inflammatory, antioxidant, antimicrobial, anti-adhesion, and angiogenic properties.^4-6 It is used as a cover or barrier when applied to soft tissues, bone, or tendon, and it is 1-mm to 3-mm thick with 10 times the tensile strength of a placental membrane.^7-8

The objective of this study is to review the outcomes of open repair of Achilles tendon ruptures augmented with vCUT compared with patients treated with standard of care only.

Four patients with acute Achilles tendon injuries surgically treated with vCUT were selected from the primary author’s clinic by retrospective chart analysis. The average age was 59 years (range, 55–65 years), and there were 2 women and 2 men. Average body mass index was 37.88 kg/m² (range, 32.44–43.75). Comorbidities included diabetes mellitus, morbid obesity, hypertension, hypercholesterolemia, osteoporosis, breast cancer, and rheumatoid arthritis (Table). Each patient had significant partial to complete ruptures with defects and underwent either end-to-end or autograft repair of the Achilles rupture. Repairs were augmented with vCUT sutured over the tendon ends (Wharton’s jelly side towards the tendon) with absorbable sutures. 

In addition, a retrospective chart review from the same institution was conducted of 4 patients (average age, 60; range, 57–63 years) who had similar degrees of Achilles rupture and similar surgical procedures without the use of biological tissues. One patient in the control received an adjunct cadaver tendon graft to aid in the structural repair of the rupture.

Patients remained nonweight-bearing after surgery for 4 to 6 weeks followed by a gradual return to ambulation. All patients maintained durable skin closure, had minimal scarring and edema, and were able to return to work in 8 to 10 weeks following surgical repair. All 4 patients returned to their preinjury activity level without pain or loss of function. There were no vCUT-related complications or adverse events.

These favorable results were compared with previous historical experience with standard of care alone (Table). The comparison showed a reduction in postoperative pain level in those patients that received vCUT; the average pain rating in vCUT group was 2.25 out of 10 compared with the control group which was 5.5 out of 10. The average time to return to shoe gear in the vCUT group was 6.25 weeks (range, 6–7 weeks) compared with the control group returning in 11.5 weeks (range, 9–15 weeks). Patient 1 in the vCUT group was a smoker and was hospitalized for intravenous steroid treatment prior to surgery to decrease edema/inflammation and still maintained durable postoperative repair of the tendon and was ambulating in shoes by 6 weeks (Figures 1, 2, 3, 4, 5, 6).

As a viable umbilical tissue, vCUT has an outer amniotic layer containing epithelial cells and an inner Wharton’s jelly layer comprised of three-dimensional extracellular matrix, proteins, growth factors, and native living cells (fibroblasts and mesenchymal stem cells). These components all contribute to stimulating healing and provide anti-inflammatory, antifibrotic, angiogenic, and antimicrobial properties.^4-6 

While the authors feel that vCUT and the described technique shows benefit to augment surgical Achilles tendon repairs, they acknowledge the limitations of this small case report. There is a need for prospective cohort studies examining patient outcomes to better understand this technique’s applicability to surgical practice.

Clinical outcomes of this study support the use of vCUT for augmentation of Achilles tendon repair. In the authors’ experience, its adjunct use resulted in decreased postoperative recovery time and a faster return to work and preinjury activities as compared with patients who were treated with standard of care only. 

Affiliation: CentraState Medical Center, Freehold, NJ; and Osiris Therapeutics, Inc, Columbia, MD

Correspondence:
Dorothy H. Kurtz Phelan, DPM
Associate Director of Medical Affairs
Osiris Therapeutics, Inc.
Medical Affairs
7015 Albert Einstein Drive
Columbia, MD 21046
dphelan@osiris.com

Disclosure: Dr. Brandeisky is a paid speaker for and Dr. Kurtz Phelan is an employee of Osiris Therapeutics, Inc (Columbia, MD). This paper was presented as a poster at the 2017 Spring Symposium on Advanced Wound Care, and a short video was produced by Wounds.