Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | November 2010 |
| End Date: | July 2013 |
| Contact: | Emily T Stansbury, BA |
| Email: | stansburyet@orthofootankle.com |
| Phone: | 614-895-2424 |
The aim of this study is to evaluate the surgical and clinical outcome of Artelon® Tissue
Reinforcement in repair of chronic ruptures or re-ruptures of the Achilles tendon, with
regard to lower leg and foot function, pain and quality of life.
Reinforcement in repair of chronic ruptures or re-ruptures of the Achilles tendon, with
regard to lower leg and foot function, pain and quality of life.
Inclusion Criteria:
1. The patient has a clinically confirmed isolated chronic rupture or rerupture of the
Achilles tendon.
2. The patient has been informed about the study and signed the patient consent form.
3. The patient reads, understands and is able to complete the study questionnaires in
English.
Exclusion Criteria:
1. The patient has an ongoing infection of the soft tissues of the ankle.
2. The patient has evidence of severe ankle arthritis.
3. The patient has a multi-system or multi-limb trauma.
4. The patient has a major medical condition that would affect quality of life and
influence the results of the study.
5. The patient is pregnant
6. The patient is not expected to complete the study according to the investigation
plan.
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