Biodegradable spacer
ProcedureImplantation of a biodegradable balloon used as a subacromial spacer.
NCT Number: NCT04571918
Massive rotator cuff tears are common in the adult population. It is estimated that about 12 % of adults 60 years of age or older suffer from a rotator cuff injury. About 40 % of these injuries are classified as massive rotator cuff tears (MRCT). MRCT propose a great challenge to the affected patient and its doctor. It is a painful condition with few treatment options.
The study aims to investigate the operative treatment for MRCT with the new treatment option proposed by Senecovic. Insertion of a biodegradable balloon as a subacromial spacer has proven promising results so far. To this date there is only small and non-randomized studies on the subject. AMRIS are planning to do a randomized controlled study where group A is treated with arthroscopic debridement, biceps tenotomy and biodegradable spacer, while group B, the control group are treated with arthroscopic debridement and biceps tenotomy.
Interested in participating?
Request Info60 year–85 year
All sexes
Interventional
Not applicable
Hospital of Southern Norway, Arendal, Arendal, Norway
The study is designed as a double blinded randomized controlled trial. The physiotherapist responsible for the clinical testing and the patient are both blinded. The surgeon knows which group the patient is in but is not responsible for any of the testing. We will randomize with envelopes perioperatively. The participants are randomized in hence "ballon" or "not ballon". In advance of the randomization the surgeon will evaluate if the patient is candidate for partial suture before randomization. We plan to stratify the patients with partial suture to ensure homogeneity between the groups.
The operation will start with arthroscopic debridement and biceps tenotomy in both groups. The patients are thereby evaluated for partial suture and randomized. The insertion of the subacromial spacer is done at the end of the operation for those patients randomized to the group "balloon". Peroperatively the surgeon will classify the grade of osteoarthritis with Outerbridge classification and the state of the rotator cuff and the long head of the biceps tendon.
Postoperative mobilization will be the following:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Implantation of a biodegradable balloon used as a subacromial spacer.
Surgery with arthroscopic debridement and biceps tenotomy
Time frame: Preop, 6 months, 1 year, 2 years, 5 years, 10 years.
A well review score that takes several factors in to account: active range of motion, activities of daily living, pain and strength. A person with a normal, healthy shoulder should score 100 points, which is maximum score. Constant score is seen as a relatively objective test, as the testing will be performed by a physiotherapist.
Time frame: Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years
Western Ontario Rotator Cuff Index is a questionnaire that explores 5 domains: physical symptoms, sports and recreation, work, social function, emotions.
Time frame: Preop. Postop: 1. day, 1 year, 2 years, 5 years, 10 years
Measure the height from the head of the humerus to the acromion
Time frame: Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years
Visual analog scale for pain in rest, activity and at night. Scale from 0 til 10.
Time frame: Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years
Questionaire for daily activity
Contact information is provided by the study sponsor or research team.
Berte Bøe, PhD
CONTACT
Hannah Ugletveit Jahr, Cand. med.
CONTACT
Oslo University Hospital
Other
Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and or Biodegradable Spacer: a Prospective Randomized Clinical Trial.
Acronym: AMRIS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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