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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04571918
Other study ID # 2019/930
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date September 1, 2029

Study information

Verified date September 2020
Source Oslo University Hospital
Contact Hannah Ugletveit Jahr, Cand. med.
Phone +47 90762377
Email hannah.jahr@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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:

- 0-2 weeks: Immobilization in a sling. The participant is advised to do simple exercises for shoulder mobilization. Restriction of movement above shoulder level.

- 2-6 weeks: Free mobilization. Advised to avoid heavy lifting.

- 6-12 weeks: Work on increasing range of motion, gradually introduce weight lifting.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date September 1, 2029
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 60 Years to 85 Years
Eligibility Inclusion Criteria:

- Patients suffering from a symptomatic massive rotator cuff tear, with fatty infiltration grade 3 or 4 classified on CT by Goutallier et al, or MRI by Fuchs classification.

- Persistent pain for at least 3 months, with documented failure of conservative treatment

- Age ranging from 60 years of age to 85 years of age

Exclusion Criteria:

- Significant shoulder osteoarthritis in the affected shoulder, Hamada classification >2.

- Total rupture of subscapularis tendon and/or teres minor, classified B and E in the Collins classification.

- Comorbidity to the degree that the patient will not be able to participate in the follow up program.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biodegradable spacer
Implantation of a biodegradable balloon used as a subacromial spacer.
Debridement and biceps tenotomy
Surgery with arthroscopic debridement and biceps tenotomy

Locations

Country Name City State
Norway Hospital of Southern Norway, Arendal Arendal
Norway Oslo university hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Constant score 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. Preop, 6 months, 1 year, 2 years, 5 years, 10 years.
Secondary WORC Western Ontario Rotator Cuff Index is a questionnaire that explores 5 domains: physical symptoms, sports and recreation, work, social function, emotions. Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years
Secondary X-ray of the shoulder Measure the height from the head of the humerus to the acromion Preop. Postop: 1. day, 1 year, 2 years, 5 years, 10 years
Secondary VAS Visual analog scale for pain in rest, activity and at night. Scale from 0 til 10. Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years
Secondary Eq-5D Questionaire for daily activity Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years
See also
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Recruiting NCT05780229 - Effectiveness of Treatments for Massive Rotator Cuff Tears: Mixed Methodology.
Recruiting NCT05001581 - Irreparable Rotator Cuff Tears Treatment. Comparison of Two Methods: With and Without Biceps Tendon Augmentation N/A
Completed NCT02049684 - SPARC: Shoulder PAtch for Rotator Cuff Tears