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

NCT04571918 | Recruiting

• 1 other identifier: 2019/930
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Massive Rotator Cuff Tears

Keywords

Ballon spacer; Biodegradable spacer; Subacromial spacer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• WORC

  Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years

• X-ray of the shoulder

  Preop. Postop: 1. day, 1 year, 2 years, 5 years, 10 years

• VAS

  Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years

• Eq-5D

  Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years

Study Arms (2)

Group A: Biodegradable spacer

EXPERIMENTAL

Intervention group

Procedure: Biodegradable spacer; Procedure: Debridement and biceps tenotomy

Group B: control group

ACTIVE COMPARATOR

Control group

Procedure: Debridement and biceps tenotomy

Interventions

Biodegradable spacer PROCEDURE

Implantation of a biodegradable balloon used as a subacromial spacer.

Group A: Biodegradable spacer

Debridement and biceps tenotomy PROCEDURE

Surgery with arthroscopic debridement and biceps tenotomy

Group A: Biodegradable spacer; Group B: control group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (2)

Hospital of Southern Norway, Arendal

Arendal, 4848, Norway

RECRUITING

Oslo university hospital

Oslo, 0424, Norway

NOT YET RECRUITING

MeSH Terms

Interventions

Debridement

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Hannah Ugletveit Jahr, Cand. med

  Hospital of southern Norway

  STUDY DIRECTOR

Central Study Contacts

Hannah Ugletveit Jahr, Cand. med.

CONTACT

+47 90762377; hannah.jahr@gmail.com

Berte Bøe, PhD

CONTACT

+47 41338451; uxbebm@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both participant and physiotherapist who are responsible for the testing will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Orthopedic surgery

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: October 1, 2020
• Study Start: November 1, 2020
• Primary Completion: September 1, 2022
• Study Completion (Estimated): September 1, 2029
• Last Updated: October 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)