Arthroscopic partial repair with or without biodegradable subacromial spacer (InSpace Balloon): a retrospective case control study

Arthroscopic partial repair with or without biodegradable subacromial spacer (InSpace Balloon): a retrospective case control study - Partial repair of MRCT with vs. without Balloon: case-control study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00014725

Enrollment

Registered

2018-05-07

Start date

2018-04-26

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

Rotator Cuff Tear

Interventions

Group 1: Patients who were suffering from massive rotator cuff tear and underwent a combined arthroscopic partial repair and subacromial balloon spacer implantation. Group 2: Patients who were sufferi

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age >50 - patients who had diagnosed symptomatic, massive or irreparable rotator cuff tear - patients who have undergone an arthroscopic partial repair in our hospital as the method of treatment (with or without InSpace Balloon) -patients with a minimum follow-up of 12 months

Exclusion criteria

Exclusion criteria: - Age <50 - Previous operation on the same joint - Glenohumeral arthritis - Irreparable subscapularis tear - Rheumatoid arthritis or other systematic diseases - Serious psychiatric diseases - active shoulder infection - uncontrolled diabetes mellitus - Coagulopathy

Design outcomes

Primary

Measure	Time frame
For the clinical assessment of the patients, the Constant Score and the American Shoulder and Elbow Surgeons Shoulder Score (ASES) has been documented. Each patient's evaluation was documented in our database on 10 days, 30 days, 3 months, 6 months, 12 months, 24 months and 36 months (when available) postoperatively. 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. 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

For the clinical assessment of the patients, the Constant Score and the American Shoulder and Elbow Surgeons Shoulder Score (ASES) has been documented. Each patient's evaluation was documented in our database on 10 days, 30 days, 3 months, 6 months, 12 months, 24 months and 36 months (when available) postoperatively. 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. 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
For the functional assessment of the patients, the Range of Motion (RoM) was measured in forward flexion, external rotation (from neutral position), external rotation (from 90° abduction) and internal rotation of the operated limb. Each patient's evaluation was documented in our database on 10 days, 30 days, 3 months, 6 months, 12 months, 24 months and 36 months (when available) postoperatively. Finally, we plan to search our department’s archives to find out: a. the demographic characteristics of the two groups, b. the type of lesion c. possible complications, d. readmissions and e. reoperations	—

Measure

Time frame

For the functional assessment of the patients, the Range of Motion (RoM) was measured in forward flexion, external rotation (from neutral position), external rotation (from 90° abduction) and internal rotation of the operated limb. Each patient's evaluation was documented in our database on 10 days, 30 days, 3 months, 6 months, 12 months, 24 months and 36 months (when available) postoperatively. Finally, we plan to search our department’s archives to find out: a. the demographic characteristics of the two groups, b. the type of lesion c. possible complications, d. readmissions and e. reoperations

—

Countries

Greece

Contacts

Public ContactEmmanouil Brilakis

Orthopaedic Surgeon,Consultant in 3r Department of Orthopaedics, HYGEIA Hospital of Athens

Ebrilakis@hygeia.gr0030 210 6867000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 28, 2026