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

NCT ID: NCT04571918

Last Updated: 2020-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2029-09-01

Brief 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.

Detailed 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.

Conditions

Massive Rotator Cuff Tears

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A: Biodegradable spacer

Intervention group

Group Type: EXPERIMENTAL

Biodegradable spacer

Intervention Type: PROCEDURE

Implantation of a biodegradable balloon used as a subacromial spacer.

Debridement and biceps tenotomy

Intervention Type: PROCEDURE

Surgery with arthroscopic debridement and biceps tenotomy

Group B: control group

Control group

Group Type: ACTIVE_COMPARATOR

Debridement and biceps tenotomy

Intervention Type: PROCEDURE

Surgery with arthroscopic debridement and biceps tenotomy

Interventions

Biodegradable spacer

Implantation of a biodegradable balloon used as a subacromial spacer.

Intervention Type: PROCEDURE

Debridement and biceps tenotomy

Surgery with arthroscopic debridement and biceps tenotomy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hannah U. Jahr

Resident in Orthopedic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hannah Ugletveit Jahr, Cand. med

Role: STUDY_DIRECTOR

Hospital of southern Norway

Locations

Hospital of Southern Norway, Arendal

Arendal, , Norway

Site Status: RECRUITING

Oslo university hospital

Oslo, , Norway

Site Status: NOT_YET_RECRUITING

Countries

Norway

Central Contacts

Hannah Ugletveit Jahr, Cand. med.

Role: CONTACT

hannah.jahr@gmail.com

+47 90762377

Berte Bøe, PhD

Role: CONTACT

uxbebm@ous-hf.no

+47 41338451

Facility Contacts

Hannah U. Jahr, Cand.med

Role: primary

hannahuj@sshf.no

+4790762377

Marek W Zegzdryn, cand.med

Role: backup

marek.walerian.zegzdryn@sshf.no

+4791143329

Berte Bøe, PhD

Role: primary

uxbebm@ous-hf.no

+4741338451

Ragnhild Støen, PhD

Role: backup

stox@ous.hf.no

Other Identifiers

2019/930

Identifier Type: -

Identifier Source: org_study_id