RC Repair Versus Subacromial Balloon Spacer in Older Adults
ConditionRotator Cuff Tears
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorPanam Clinic
About this trial
The purpose of this pilot study is to assess the feasibility of a full randomized trial design.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
70 years of age or older
clinical and radiological diagnosis of a full thickness supraspinatus (or larger) RC tear >2cm or more than 1 full tendon
ongoing symptoms after 3 months of physiotherapy
a tendon amenable to partial or complete repair (as determined by pre-operative MRI)
Disqualifiers
previous surgery or pseudoparalysis on study shoulder
complete subscapularis deficiency
external rotation lag signs
avascular necrosis
Trial design
Design model
Parallel
Treatments tested in this trial
Subacromial spacer implantation
Procedure/SurgeryA biodegradable balloon implanted arthroscopically between the acromion and humeral head with tenotomy of long head of biceps.
Rotator cuff repair
Procedure/SurgeryRotator cuff repair with tenotomy of long head of biceps.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Subacromial spacer implantationExperimental treatment 1 intervention
Group B: Rotator Cuff RepairActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Study feasibility - randomized
Percentage of patients randomized
Time frame
1 year2
Study feasibility - recruitment
Number of screened patients and proportion that are deemed eligible that consent
Time frame
1 year3
Study feasibility - surgery
Consensus among surgeon co-investigators regarding the standardized peri-operative orders and surgical techniques.
Time frame
1 yearSecondary outcomes
1
ASES Score
The ASES is a patient-reported upper extremity-specific functional assessment tool and is scored out of a maximum 100 points, where 100 represents maximum function and no pain (Richards et al., 1994). It has a pain component measured on a visual analog scale as well as ten Likert-scale questions on function (e.g., put on a coat, sleep on affected side). The ASES is reliable and is validated for this population and is one of the most commonly used shoulder outcomes in North America.
Time frame
Baseline, pre-operative2
ASES Score
The ASES is a patient-reported upper extremity-specific functional assessment tool and is scored out of a maximum 100 points, where 100 represents maximum function and no pain (Richards et al., 1994). It has a pain component measured on a visual analog scale as well as ten Likert-scale questions on function (e.g., put on a coat, sleep on affected side). The ASES is reliable and is validated for this population and is one of the most commonly used shoulder outcomes in North America
Time frame
3 Months, post-operative3
ASES Score
The ASES is a patient-reported upper extremity-specific functional assessment tool and is scored out of a maximum 100 points, where 100 represents maximum function and no pain (Richards et al., 1994). It has a pain component measured on a visual analog scale as well as ten Likert-scale questions on function (e.g., put on a coat, sleep on affected side). The ASES is reliable and is validated for this population and is one of the most commonly used shoulder outcomes in North America
Time frame
6 Months, post-operative4
ASES Score
The ASES is a patient-reported upper extremity-specific functional assessment tool and is scored out of a maximum 100 points, where 100 represents maximum function and no pain (Richards et al., 1994). It has a pain component measured on a visual analog scale as well as ten Likert-scale questions on function (e.g., put on a coat, sleep on affected side). The ASES is reliable and is validated for this population and is one of the most commonly used shoulder outcomes in North America
Time frame
12 Months, post-operativeLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Panam Clinic
Lead sponsor
University of Manitoba
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: