Arthroscopic partial repair with or without biodegradable subacromial spacer (InSpace Balloon): A randomised controlled clinical trial

Arthroscopic partial repair with or without biodegradable subacromial spacer (InSpace Balloon): A randomised controlled clinical trial - Arthroscopic Partial Repair with or without Balloon

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00014716

Enrollment

Registered

2018-05-03

Start date

2018-05-09

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Massive Rotator Cuff tear M75.1 S46.0

Interventions

Group 1: Patients who will undergo arthroscopic partial repair + subacromial biodegradable spacer (InSpace Balloon implantation) Group 2: Patients who will receive only an arthroscopic partial repair

Eligibility

Sex/Gender

All

Age

55 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 55-75 2. Diagnosed symptomatic, a. massive or b. irreparable rotator cuff’s tear (clinically and arthroscopically) {subgroups a. and b.} 3. Arthroscopic Partial Repair as the method of treatment (with or without InSpace Balloon) 4. Sign full written consent 5. Complete their scheduled follow-up

Exclusion criteria

Exclusion criteria: 1. Age75 2. Previous operation on the same joint 3. Irreparable subscapularis tear 4. Glenohumeral osteoarthritis 5. AC joint osteoarthritis 6. Ipsilateral shoulder instability 7. significant pathology from the cervical spine (creating symptoms like pain) 8. Rheumatoid arthritis or other systematic diseases 9. Serious psychiatric diseases

Design outcomes

Primary

Measure	Time frame
The rate of success will be calculated by the difference in Constant and ASES scores from pre-operation minus the final Constant and ASES score (12-month: short-term, 24-month-mid-term, 48-month: long-term assessment). Particularly, we established two separate primary criteria for the patients which were categorized as succeeded-treated: a. a bigger than 10.4 positive difference between the final follow-up Constant score and the initial Constant score (this is the officially established minimal clinically important difference or MCID) and b. a bigger than 17 positive difference between the final follow-up ASES score and the initial ASES score (this is the officially established minimal clinically important difference or MCID).	—

Measure

Time frame

The rate of success will be calculated by the difference in Constant and ASES scores from pre-operation minus the final Constant and ASES score (12-month: short-term, 24-month-mid-term, 48-month: long-term assessment). Particularly, we established two separate primary criteria for the patients which were categorized as succeeded-treated: a. a bigger than 10.4 positive difference between the final follow-up Constant score and the initial Constant score (this is the officially established minimal clinically important difference or MCID) and b. a bigger than 17 positive difference between the final follow-up ASES score and the initial ASES score (this is the officially established minimal clinically important difference or MCID).

—

Secondary

Measure	Time frame
A secondary criterion for the success rate will be a bigger than 20 negative difference between the final follow-up VAS score 100/100 for satisfaction (12-month: short-term, 24-month-mid-term, 48-month: long-term assessment) and the initial VAS-satisfaction score.	—

Countries

Greece

Contacts

Public ContactGrigorios Avramidis

Orthopaedic Surgeon

gregory13avramidis@gmail.com0030 6976767962

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026