Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and Biodegradable Spacer.

Massive Rotator Cuff Tears Clinical Trial

— AMRIS  

Official title:

Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and or Biodegradable Spacer: a Prospective Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04571918
• Other study ID #: 2019/930
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Massive Rotator Cuff Tears
• Rotator Cuff Injuries

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