Rotator Cuff Reconstruction With Xenologous Dermis-patch Augmentation and ACP® - Injection

NCT01586351 | Completed

• 1 other identifier: ACP02
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to show that an augmentation with the DX Reinforcement Matrix from Arthrex is possible with the arthroscopic technique.

Conditions

Rotator Cuff Tears

Keywords

Rotator cuff tears; ACP; DX Reinforcement Matrix

Outcome Measures

Primary Outcomes (1)

• Oxford Shoulder Score (Questionnaire)

  The Oxford Shoulder Score used after 3 months is the primary parameter. The Score tests the ability to participate in the patients' normal life before they got injured.

  3mo

Secondary Outcomes (10)

• VAS Pain Scoring Tool

  10d

• QuickDASH Questionnaire (Short version of Disability of the Arm, Shoulder and Hand Questionnaire)

  3/6/24mo

• EQ-5D Questionnaire

  3/6/24 mo

• ROM (degrees)

  3/6/24mo

• Measurement of the abduction strength (Kilograms)

  3/6/24 mo

Study Arms (1)

Patch and ACP Treatment

Patents who get an patch augmentation and ACP injection following an arthroscopic repair of the rotator cuff.

Device: Patch Augmentation and ACP injection

Interventions

Patch Augmentation and ACP injection DEVICE

Patch augmentation and 4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.

Also known as: ACP, DX Reinforcement Matrix

Patch and ACP Treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The potential patients will be recruited from the operation list due to the inclusion and exclusion criteria.

You may qualify if:

• Arthroscopic rotator cuff reconstructions of degenerative or traumatic full thickness rotatorcuff tears (supraspinatus should be affected)performed by Dr. Flury
• Age: 60 years or more
• Suture bridge technique
• Women: No longer of childbearing age (at menopause and last menstrual period more than 12 months, prevented surgically Ovaries and/or uterus removed surgically)
• Signed consent form

You may not qualify if:

• Partial reconstruction of the rotator cuff (PASTA)
• Open reconstruction
• Tendon transfer (latissimus dorsi or pectoralis major)
• Revision surgery
• Omarthrosis (Level ≥ 2 Samilson \& Prieto)
• Systemic arthritis
• Rheumatoid arthritis
• Diabetes (insulin treated)
• Requiring surgery in reconstruction of the subscapularis tendon
• Acute or chronic infection
• Pathological bone metabolism
• Insufficient perfusion in the affected arm
• Neuromuscular disease in the affected arm
• Non compliance of the patient
• Disorders which handicap or inhibit the patient to follow the orders of the clinical testers

Sponsors & Collaborators

• Schulthess Klinik: lead
• Arthrex, Inc.: collaborator

Study Sites (1)

Schulthess Klinik

Zurich, Canton Zürich, Switzerland

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Matthias Flury, Dr

  Upper Extremities Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Department of Upper Extremity)

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: April 26, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2016
• Last Updated: April 22, 2016

Record last verified: 2016-04

Locations

CH (1)