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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Massive Rotator Cuff Tears
• Intervention / Treatment: Procedure: Biodegradable spacer; Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannah Ugletveit Jahr, Cand. med.; Phone Number: +47 90762377; Email: hannah.jahr@gmail.com
• Study Contact Backup: Name: Berte Bøe, PhD; Phone Number: +47 41338451; Email: uxbebm@ous-hf.no

Study Locations

• Norway
  • Arendal, Norway, 4848
    • Recruiting
    • Hospital of Southern Norway, Arendal
    • Contact: Hannah U. Jahr, Cand.med; Phone Number: +4790762377; Email: hannahuj@sshf.no
    • Contact: Marek W Zegzdryn, cand.med; Phone Number: +4791143329; Email: marek.walerian.zegzdryn@sshf.no
  • Oslo, Norway, 0424
    • Not yet recruiting
    • Oslo University Hospital
    • Contact: Berte Bøe, PhD; Phone Number: +4741338451; Email: uxbebm@ous-hf.no
    • Contact: Ragnhild Støen, PhD; Email: stox@ous.hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Biodegradable spacer; Intervention group	Procedure: Biodegradable spacer; Implantation of a biodegradable balloon used as a subacromial spacer.; Procedure: Debridement and biceps tenotomy; Surgery with arthroscopic debridement and biceps tenotomy
Active Comparator: Group B: control group; Control group	Procedure: Debridement and biceps tenotomy; Surgery with arthroscopic debridement and biceps tenotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Eq-5D	Questionaire for daily activity	Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Director: Hannah Ugletveit Jahr, Cand. med, Hospital of southern Norway

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2029

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 25, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Ballon spacer; Biodegradable spacer; Subacromial spacer
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 2019/930

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: To ensure anonymization of participants, there is no plan to share individual data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No