Back to resultsComparison of Arthroscopic Supraspinatus Tendon Tear Repair in Patients Over 60 Years With and Without Patch Augmentation.
Primary Purpose
Rotator Cuff Tears
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pitch Patch
ArthroFlex
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tears
Eligibility Criteria
Inclusion Criteria:
- Rotator cuff tear > 2 cm in the sagittal plane involving the supraspinatus tendon as well as at least the superior 1/3 of the infraspinatus tendon
- Indicated for surgical reconstruction by arthroscopy
- Patient aged 60 years and over
- Consenting participation in this study by signing the Informed Consent form
Exclusion Criteria:
- Osteoarthritis (grade ≥ 2 after Samilson & Prieto)
- Advanced fatty infiltration of the rotator cuff muscles (Goutallier grade III or IV)
- Tear of the subscapularis > Typ 1 Lafosse (partial tears of superior 1/3 of the tendon)
- Irreparable tear of the supraspinatus
- General medical contraindication to surgery
- Known hypersensitivity to the materials used
- Revision operations
- Open reconstruction
- Tendon transfer necessary (latissimus dorsi or pectoralis major)
Any disease process that would preclude accurate evaluation including:
- Systemic arthritis, rheumatoid arthritis, diabetes (insulin dependent), acute or chronic infection, abnormal bone metabolism, tumour / malignoma, psychiatric disorder
- Inadequate blood flow or neuromuscular disease in the affected arm
- Recent history of substance abuse
- Legal incompetence
- German language barrier to complete the questionnaires or
- Participation in any other medical device or medicinal product study that could influence the results of the present study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Intervention group 1: Pitch-Patch
Intervention group 2: ArthroFlex
Control
Arm Description
Reconstruction with patch augmentation using a synthetic patch
Reconstruction with patch augmentation using a biological human dermis patch
Outcomes
Primary Outcome Measures
Occurrence of retear
Repair integrity will be assessed by an independent assessor on the basis of centralized MRI images.
Secondary Outcome Measures
Pain level (NRS)
The pain level in the operated shoulder will be measured with a numeric rating scale (0=no pain, 10 = maximum pain) as part as the Constant Murley Score (CS)
Range of motion (flexion, abduction, external and internal rotation)
The following active and passive range of motion parameters of the affected shoulder will be documented using a goniometer : Elevation (flexion), abduction, External rotation by 0° abduction, external-internal rotation by 90° abduction
Shoulder strength in 90° abduction and in external rotation (0° abduction)
The shoulder strenght will be measured with an isobex device
Constant Murley Score (CS)
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.
Oxford Shoulder Score (OSS)
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.
Subjective shoulder value (SSV)
The Subjective Shoulder Value (SSV) is based on a single question that is answered subjectively by the patients. The English formulation of this question is: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?"
Quality of life (utilities) and general health using EQ-5D-5L
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.
Subjective improvement, expectation, satisfaction with treatment
Patients will be asked to assess their current state of health related to the operated shoulder at follow-up compared to the state before surgery. Further on A similar question will be asked regarding their perceived change in quality of life.At the 24-month follow-up questionnaire, patients will rate whether the surgical results met their expectations:
Adverse events / complications
Adverse events will be analyzed according to their type and time of occurrence, severity and relation-to-implant: Local AEs within 24 months and Non-local AEs within 3 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03511547
Brief Title
Comparison of Arthroscopic Supraspinatus Tendon Tear Repair in Patients Over 60 Years With and Without Patch Augmentation.
Official Title
Arthroscopic Rotator Cuff Reconstruction With or Without Biologic or Synthetic Patch Augmentation in Patients Over 60 Years: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Personal reasons
Study Start Date
January 1, 2018 (Anticipated)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schulthess Klinik
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to show that patch augmentation in rotatorcuff tear results in lower rate of recurrent tendon defects compared without patches.
Detailed Description
An arthroscopic rotator cuff repair is nowadays mostly implemented in order to restore function and reduce or eliminate pain. The primary objective of this randomized controlled trial is to demonstrate, in patients 60 years or older with a large rotator cuff tear, that biological or synthetic patch augmen-tation in arthroscopic rotator cuff repair results in decreased rate of retear 24 months post-operatively compared to re-pair without patch augmentation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group 1: Pitch-Patch
Arm Type
Active Comparator
Arm Description
Reconstruction with patch augmentation using a synthetic patch
Arm Title
Intervention group 2: ArthroFlex
Arm Type
Active Comparator
Arm Description
Reconstruction with patch augmentation using a biological human dermis patch
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Pitch Patch
Intervention Description
The patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a synthetic (Pitch-Patch™ [PP]) augmentation.
Intervention Type
Device
Intervention Name(s)
ArthroFlex
Intervention Description
The patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a biologic patch (ArthroFlex® [AF]) augmentation.
Primary Outcome Measure Information:
Title
Occurrence of retear
Description
Repair integrity will be assessed by an independent assessor on the basis of centralized MRI images.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Pain level (NRS)
Description
The pain level in the operated shoulder will be measured with a numeric rating scale (0=no pain, 10 = maximum pain) as part as the Constant Murley Score (CS)
Time Frame
6/24 months
Title
Range of motion (flexion, abduction, external and internal rotation)
Description
The following active and passive range of motion parameters of the affected shoulder will be documented using a goniometer : Elevation (flexion), abduction, External rotation by 0° abduction, external-internal rotation by 90° abduction
Time Frame
6/24 months
Title
Shoulder strength in 90° abduction and in external rotation (0° abduction)
Description
The shoulder strenght will be measured with an isobex device
Time Frame
6/24 months
Title
Constant Murley Score (CS)
Description
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.
Time Frame
6/24 months
Title
Oxford Shoulder Score (OSS)
Description
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.
Time Frame
6/24 months
Title
Subjective shoulder value (SSV)
Description
The Subjective Shoulder Value (SSV) is based on a single question that is answered subjectively by the patients. The English formulation of this question is: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?"
Time Frame
6/24 months
Title
Quality of life (utilities) and general health using EQ-5D-5L
Description
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.
Time Frame
6/24 months
Title
Subjective improvement, expectation, satisfaction with treatment
Description
Patients will be asked to assess their current state of health related to the operated shoulder at follow-up compared to the state before surgery. Further on A similar question will be asked regarding their perceived change in quality of life.At the 24-month follow-up questionnaire, patients will rate whether the surgical results met their expectations:
Time Frame
6/24 months
Title
Adverse events / complications
Description
Adverse events will be analyzed according to their type and time of occurrence, severity and relation-to-implant: Local AEs within 24 months and Non-local AEs within 3 months
Time Frame
3/6/24 months and intra-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rotator cuff tear > 2 cm in the sagittal plane involving the supraspinatus tendon as well as at least the superior 1/3 of the infraspinatus tendon
Indicated for surgical reconstruction by arthroscopy
Patient aged 60 years and over
Consenting participation in this study by signing the Informed Consent form
Exclusion Criteria:
Osteoarthritis (grade ≥ 2 after Samilson & Prieto)
Advanced fatty infiltration of the rotator cuff muscles (Goutallier grade III or IV)
Tear of the subscapularis > Typ 1 Lafosse (partial tears of superior 1/3 of the tendon)
Irreparable tear of the supraspinatus
General medical contraindication to surgery
Known hypersensitivity to the materials used
Revision operations
Open reconstruction
Tendon transfer necessary (latissimus dorsi or pectoralis major)
Any disease process that would preclude accurate evaluation including:
Systemic arthritis, rheumatoid arthritis, diabetes (insulin dependent), acute or chronic infection, abnormal bone metabolism, tumour / malignoma, psychiatric disorder
Inadequate blood flow or neuromuscular disease in the affected arm
Recent history of substance abuse
Legal incompetence
German language barrier to complete the questionnaires or
Participation in any other medical device or medicinal product study that could influence the results of the present study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Scheibel, Prof
Organizational Affiliation
Schulthess Klinik
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Arthroscopic Supraspinatus Tendon Tear Repair in Patients Over 60 Years With and Without Patch Augmentation.
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