This is a post-marketing study to further assess the safety and efficacy of the InSpace* device implantation in comparison to surgical repair of full thickness MRCT . The efficacy will be assessed by comparing the pre- and post- operative shoulder…
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy outcome of the study is considered as the subject response
rate at 6 month post-surgery or device implantation.
Subject will be defined as responder if improvement of at least 10 points of
the total score from baseline (pre-operation) to 6 month follow up visit of at
least one of the shoulder assessment outcome scores (ASES, Constant) is
observed.
Secondary outcome
- Overall change of total shoulder outcome questionnaires scores from baseline
to each follow-up visit (3w, 3m, 6m, 12m and 24m) at each treatment arm.
- Overall change in pain score from baseline to each follow-up visit (3w, 3m,
6m, 12m and 24m) at each treatment arm.
- Overall change in ADL from baseline to each follow-up visit (3w, 3m, 6m, 12m
and 24m) at each treatment arm.
- Overall change in ROM from baseline to each follow-up visit (3w, 3m, 6m, 12m
and 24m) at each treatment arm.
- Overall change in Quality of Life parameters (EQ-5D-5L) from baseline to each
follow-up visit (3w, 3m, 6m, 12m and 24m) at each treatment arm.
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- Time to return to work/daily activities as presented by the overall change in
activity of daily living scores from baseline to each follow-up visit (3w, 3m,
6m, 12m and 24m) at each treatment arm.
- Safety assessments: Comparison of device/procedure related AEs/SAEs at each
treatment arm (including re-operation rate).
- Re-tear rate at 12m as assessed by independent MRI evaluation.
- Total operation time at each treatment arm
- Subject satisfaction at 6m, 12m and 24m post-surgery.
- Descriptive presentation of the amount of required pain-relief medications at
each treatment arm (based on physician assessment and ASES relevant questions)
during the study follow-up period up to 12m post-surgery and comparison between
the groups , if applicable.
Background summary
The incidence of Rotator cuff tears increases in frequency with age, is more
common in the dominant arm, mostly to people with frequent overhead activity
(painting, tennis players, construction workers etc.) and can be present in the
opposite shoulder even if there is no pain. It appears that 30-40% of the
population suffers from rotator cuff disease and 5-10% with clinical symptoms.
In the USA, 5.4 million visits to a physician due to rotator cuff disease
symptoms were done in 2004 and 250000 surgical treatments conducted in the same
year.
RCTs are being classified by the size of the tear, the presence of tendon
retraction, chronicity of the injury and the amount of muscle atrophy and
degree of fatty degeneration. A range of surgical options are available
including debridement, (with or without partial tendon repair), tendon
transfer, muscle-tendon slide procedures, the utilization of rotator cuff
allograft and synthetic graft materials, arthrodesis, reverse arthroplasty or
hemiarthroplasty. It has been reported in MRCTs, that primary repairs will
re-rupture in between 20-65% of patients over time. Although patients with
MRCTs may be capable of generating glenohumeral abduction, (with or without
translation of the humeral head), methods designed to reduce pain will result
in significantly improved shoulder kinematics.
Our assumption is that the deployment of an inflatable balloon into the
subacromial space in patients with MRCTs will prevent impingement during
abduction, resulting in painless activation of the scapulohumeral musculature.
Moreover, lowering of the humeral head during balloon inflation may provide an
improved balance between the subscapularis anteriorly and the infraspinatus
posteriorly and permit better deltoid activation and compensation through the
arc of motion .
Study objective
This is a post-marketing study to further assess the safety and efficacy of the
InSpace* device implantation in comparison to surgical repair of full
thickness MRCT .
The efficacy will be assessed by comparing the pre- and post- operative
shoulder function as assessed by the total scores of the ASES, Constant, Quick
DASH and WORC outcome questionnaires.
Overall improvement in Quality of Life parameters will be assessed using
EQ-5D-5L questionnaire.
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Intervention
The subjects will be randomized with a 1:1 ratio to one of the following study
arms:
Arm A (Control arm) :Subjects will undergo surgical intervention (arthroscopic
or mini-open procedure) to perform debridement, acromioplasty if deemed
necessary, long head of biceps tenotomy, and at least partial repair of the
full thickness MRCT.
Arm B (Study arm) : Subjects will undergo arthroscopic surgical intervention to
perform debridement, acromioplasty if deemed necessary, long head of biceps
tenotomy, and placement of the InSpace* balloon. In case sub-scapularis tear
is detected, it can be repaired prior to device implantation.
Study burden and risks
Anticipated Clinical Benefits
Potential benefits that may be realized by the subjects treated with InSpace*
include favorable functional outcome of the shoulder function in terms of
reduction of daily and night pain and smoother return to activity of daily
living.
Another known benefit to subjects participating in any clinical study is the
ability to learn more about their medical condition through the assessments
that will be performed throughout the course of the study. Additionally,
subjects will be closely observed by the study staff throughout their
participation in the study.
Risk Analysis and Residual Risks
Risk analysis activities were performed throughout the development process and
life cycle of the InSpace* device in compliance with the requirements of EN-
ISO 14971 *Application of risk management to medical devices* (2012).
Prior to risk mitigation, all the risks identified were categorized as
acceptable, and none were categorized as unacceptable. A comprehensive design
verification and validation process, including bench tests and animal data,
further demonstrates the safe and effective profile of the InSpace* device.
Halamish 7
St. Caesarea 30889
IL
Halamish 7
St. Caesarea 30889
IL
Listed location countries
Age
Inclusion criteria
-Male or female age 40 or older
-Positive diagnostic imaging (based on MRI within 9 months of consent date) of the affected shoulder indicating full thickness Massive RCT of at least 5cm in diameter (according to Cofield classification) or long - narrow tears of at least 4cm2 (W>2cm and L>2cm) including fatty infiltration grade III or IV (according to classification of Goutallier) involving more than one tendon
-Persistent pain of the affected shoulder for at least 3 months with no response to conservative treatment (such as physical therapy, pain relief medication, local steroid injection etc.)
-Mentally and physically able to fully comply with the protocol procedures including adherence to follow-up schedule and completion of the required subject*s questionnaires.
-Willing to undergo video/photographic documentation of affected shoulder during shoulder evaluation
Exclusion criteria
-Known allergy to the device material (copolymer of PLA and -*-caprolactone)
- Evidence of severe osteoarthritis, arthropathy or cartilage damage of the shoulder with loss of passive gleno-humarel joint range of motion
- Evidence of gleno-humeral instability
-Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
-Evidence of major joint trauma, infection, or necrosis in the shoulder
-Partial-thickness tears of the rotator cuff
-Unable to provide informed consent or complete required questionnaires due to language barrier or mental status
-Major medical condition that could affect quality of life and influence the results of the study (i.e: HIV or other immunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA etc.)
-Documented or known drug or alcohol abuses that could affect quality of life and influence the results of the study
-Unwilling to be followed for the entire duration of the study
-Subjects with worker compensation claims or other litigation claims related to the shoulder being treated in the study
-Females of child-bearing potential who are pregnant or breastfeeding, or plan to become pregnant during the course of the study
-Concurrent participation in any other invasive clinical study one month prior to enrollment to the study and during the entire study period.
-The subject has implanted metallic devices (cardiac pacemakers, insulin pumps, and nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI scan of the shoulder
-The subject has claustrophobia that would inhibit their ability to undergo an MRI scan of the shoulder
-The subject has known allergy to the required pre-operative broad spectrum antibiotic.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01890733 |
| CCMO | NL49663.098.14 |