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

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ClinicalTrials.gov Identifier: NCT04571918
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Hannah U. Jahr, Oslo University Hospital

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.


Condition or disease Intervention/treatment Phase
Massive Rotator Cuff Tears Procedure: Biodegradable spacer Procedure: Debridement and biceps tenotomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Both participant and physiotherapist who are responsible for the testing will be masked.
Primary Purpose: Treatment
Official Title: Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and or Biodegradable Spacer: a Prospective Randomized Clinical Trial.
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2029

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




Primary Outcome Measures :
  1. Change in Constant score [ 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.


Secondary Outcome Measures :
  1. WORC [ 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.

  2. X-ray of the shoulder [ 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

  3. VAS [ 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.

  4. Eq-5D [ Time Frame: Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years ]
    Questionaire for daily activity



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04571918


Contacts
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Contact: Hannah Ugletveit Jahr, Cand. med. +47 90762377 hannah.jahr@gmail.com
Contact: Berte Bøe, PhD +47 41338451 uxbebm@ous-hf.no

Locations
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Norway
Hospital of Southern Norway, Arendal Recruiting
Arendal, Norway, 4848
Contact: Hannah U. Jahr, Cand.med    +4790762377    hannahuj@sshf.no   
Contact: Marek W Zegzdryn, cand.med    +4791143329    marek.walerian.zegzdryn@sshf.no   
Oslo university hospital Not yet recruiting
Oslo, Norway, 0424
Contact: Berte Bøe, PhD    +4741338451    uxbebm@ous-hf.no   
Contact: Ragnhild Støen, PhD       stox@ous.hf.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Study Director: Hannah Ugletveit Jahr, Cand. med Hospital of southern Norway
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Responsible Party: Hannah U. Jahr, Resident in Orthopedic surgery, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04571918    
Other Study ID Numbers: 2019/930
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: To ensure anonymization of participants, there is no plan to share individual data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hannah U. Jahr, Oslo University Hospital:
Ballon spacer
Biodegradable spacer
Subacromial spacer
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries