Rotator Cuff TearsNCT01586351
Rotator Cuff Reconstruction With Xenologous Dermis-patch Augmentation and ACP® - Injection
An observational study of Rotator Cuff Tears, run by Schulthess Klinik at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Patch Augmentation and ACP injection
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2012to Mar 2016
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The potential patients will be recruited from the operation list due to the inclusion and exclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- Rheumatoid arthritis
- Diabetes (insulin treated)
- Requiring surgery in reconstruction of the subscapularis tendon
- Progressive fat inclusion (fatty infiltration of the rotator cuff musculature goutallier level IV
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Rotator Cuff Reconstruction With Xenologous Dermis-patch Augmentation and ACP® - Injection in Patients Over 60 Years (ACP = Autologous Conditioned Plasma)
The purpose of this study is to show that an augmentation with the DX Reinforcement Matrix from Arthrex is possible with the arthroscopic technique.
Read the detailed description
The shoulder joint, specially the rotator cuff, is one of the most complicated joints of the human body. If the tendon has to be fixed at the bone during surgery, the weak point in obtaining a successful surgery is the fixation of the tendon at the bone insertion site. Tendon belongs to the bradytrophic tissue conditional on the reduced blood flow, deep mitosis rate and lowered healing potential.
The patients in this study have 60 years or more. The tissue of these patients isn't as good as in young patients. The patch will be used to improve the strength of the tendon at the insertion site and the ingrowth process of the new tissue at this area. Additionally the investigators can boost the healing process with a selective use of PRP (PRP = platelet rich plasma). In this process, the healing site is delivered with an elevated concentration of thrombocytes and also growth factors which are constituent parts of them.
- Conditions
- Rotator Cuff Tears
- Being tested
- Patch Augmentation and ACP injection
- Keywords
- Rotator cuff tears, ACP, DX Reinforcement Matrix
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patch Augmentation and ACP injectionDevice
Also called ACP, DX Reinforcement Matrix
Patch augmentation and 4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.
| Study group | Role | What they receive |
|---|---|---|
| Patch and ACP Treatment | Patents who get an patch augmentation and ACP injection following an arthroscopic repair of the rotator cuff. Receives: Device: Patch Augmentation and ACP injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3mo
Secondary outcomes (10)
VAS Pain Scoring Tool
Measuring of the pain with a VAS pain scale during 10 days post-operative
Measured: 10d
QuickDASH Questionnaire (Short version of Disability of the Arm, Shoulder and Hand Questionnaire)
The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb.
The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.
Measured: 3/6/24mo
EQ-5D Questionnaire
EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys.
Measured: 3/6/24 mo
ROM (degrees)
Range of motion refers to the distance and direction a joint can move.
Measured: 3/6/24mo
Measurement of the abduction strength (Kilograms)
Measured: 3/6/24 mo
ASES Score (American Shoulder And Elbow Surgeons Questionnaire)
The ASES was developed to measure functional limitations and shoulder pain in people with musculoskeletal pathologies. Pain score was calculated from a single pain question on a visual analog scale (pain symptoms) and a function score from the sum of 10 questions addressing function using a 4-point ordinal scale (physical function). Pain and function are weighted equally and the total score ranges from 0 to 100 points, where 0 = worst and 100 = best.
Measured: 3/6/24mo
Constant Murley Score (CMS)
The CMS is a 100-point scoring system that is divided into four subscales: pain (15 points), activities of daily living (20 points), range of motion (40 points) and strength (25 points).Pain and activities of daily living are self-reported by the patient using visual analog scales and ordinal categories. Range of motion is obtained during active painfree elevation in flexion and abduction (using a goniometer), and functional internal and external rotation of the shoulder (using ordinal scale). Strength testing was performed at 90° of abduction in the scapular plane.
Measured: 3/6/24 mo
MRI/X-Ray/Ultrasonic Diagnostics (Objective Evaluation (Descriptive) of the healing process)
Measured: 6/24 mo
Measurement of the external rotation strength (Kilograms)
Measured: 3/6/24 mo
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.
Measured: 6mo/24mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2014
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Principal investigator, Matthias Flury, Schulthess Klinik
- Investigators
- Matthias Flury, Dr, Principal investigator, Upper Extremities Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586351
- Sponsor's protocol ID
- ACP02
- Status last verified
- Apr 2016
- First submitted
- 24 Apr 2012
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Rotator Cuff Reconstruction With Xenologous Dermis-patch Augmentation and ACP® - Injection in Patients Over 60 Years (ACP = Autologous Conditioned Plasma)
- ClinicalTrials.gov ID
- NCT01586351
- Acronym / sponsor ID
- ACP02
- Conditions
- Rotator Cuff Tears
- Keywords
- Rotator cuff tears, ACP, DX Reinforcement Matrix
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- Oct 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to show that an augmentation with the DX Reinforcement Matrix from Arthrex is possible with the arthroscopic technique.
Detailed description
The shoulder joint, specially the rotator cuff, is one of the most complicated joints of the human body. If the tendon has to be fixed at the bone during surgery, the weak point in obtaining a successful surgery is the fixation of the tendon at the bone insertion site. Tendon belongs to the bradytrophic tissue conditional on the reduced blood flow, deep mitosis rate and lowered healing potential.
The patients in this study have 60 years or more. The tissue of these patients isn't as good as in young patients. The patch will be used to improve the strength of the tendon at the insertion site and the ingrowth process of the new tissue at this area. Additionally the investigators can boost the healing process with a selective use of PRP (PRP = platelet rich plasma). In this process, the healing site is delivered with an elevated concentration of thrombocytes and also growth factors which are constituent parts of them.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patch and ACP Treatment | – | Device: Patch Augmentation and ACP injectionPatents who get an patch augmentation and ACP injection following an arthroscopic repair of the rotator cuff. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The potential patients will be recruited from the operation list due to the inclusion and exclusion criteria.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- Partial reconstruction of the rotator cuff (PASTA)
- Open reconstruction
- Tendon transfer (latissimus dorsi or pectoralis major)
- Revision surgery
- Omarthrosis (Level ≥ 2 Samilson \& Prieto)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patch Augmentation and ACP injectionAlso: ACP, DX Reinforcement MatrixPatch augmentation and 4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff. | Device | Patch and ACP Treatment |
Primary outcome
Oxford Shoulder Score (Questionnaire)
Time frame: 3mo
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.
10 secondary outcomes
VAS Pain Scoring Tool
Time frame: 10d
QuickDASH Questionnaire (Short version of Disability of the Arm, Shoulder and Hand Questionnaire)
Time frame: 3/6/24mo
EQ-5D Questionnaire
Time frame: 3/6/24 mo
ROM (degrees)
Time frame: 3/6/24mo
Measurement of the abduction strength (Kilograms)
Time frame: 3/6/24 mo
ASES Score (American Shoulder And Elbow Surgeons Questionnaire)
Time frame: 3/6/24mo
Constant Murley Score (CMS)
Time frame: 3/6/24 mo
MRI/X-Ray/Ultrasonic Diagnostics (Objective Evaluation (Descriptive) of the healing process)
Time frame: 6/24 mo
Measurement of the external rotation strength (Kilograms)
Time frame: 3/6/24 mo
Oxford Shoulder Score (Questionnaire)
Time frame: 6mo/24mo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Flury, Dr principal investigator
Upper Extremities Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tears, run by Schulthess Klinik at 1 site in Switzerland.
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 5 inclusion and 16 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 22 Apr 2016. 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 Switzerland. 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. 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?
Oxford Shoulder Score (Questionnaire) (time frame: 3mo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2016.