Prospective investigation for surgical therapy of non-reconstructable rotator cuff lesions

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00022942

Enrollment

Registered

2020-08-27

Start date

2020-08-31

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

M75.1

Interventions

Group 1: Inspace-balloon implantation Group 2: Transfer of latissimus-dorsi muscle

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Non-reconstructable ruptures of the tendons of the supraspinatus and infraspinatus • Pain and significant restrictions in everyday and professional life • good passive mobility in the shoulder joint • Radiographically centered articulation in the glenohumeral joint • MRI-morphological lesion size of grade III according to Bateman, degree of retraction from III to Patte, higher-grade fatty infiltration (from grade III according to Fuchs), advanced muscular atrophy (from grade II according to Thomazeau) • Intact subscapular tendon

Exclusion criteria

Exclusion criteria: • acute inflammation • Paresis of the upper extremity • Stages of omarthrosis> 1 according to Hamada

Design outcomes

Primary

Measure	Time frame
Age- and gender-adapted Constant-Murley Score 2 years postoperatively. Significant difference between the two established replacement methods.	—

Secondary

Measure	Time frame
1. Secondary hypothesis: In addition to the Constant-Murley score, there are further differences in the postoperative outcome between the two established replacement methods. 1.1 There are differences in the results of the clinical lag signs and general patient satisfaction. 1.2 The choice of the substitute procedure determines the progression of the defect arthropathy (classification according to Hamada). 1.3 The choice of the replacement procedure depends on the postoperative acromiohumeral distance and thus the radiological centering of the humeral head. Second hypothesis: The progression of a defect arthropathy as a result of non-reconstructable rotator cuff ruptures can be stopped with the aid of replacement methods. 2.1 The latency between the first clinical complaints and the time of operation has an influence on the progression of the defect arthropathy. 2.2 A preoperatively reduced acromiohumeral distance correlates with a greater postoperative progression of the defect arthopathy. 2.3 The postoperative acromiohumeral distance and thus the radiological centering of the humeral head correlates with a better functional result. 3. Secondary hypothesis: Clinical and radiological predictors of the postoperative outcome can be defined. 3.1 The latency between the first clinical complaints and the time of operation has an influence on the postoperative Constant-Murley score. 3.2 A preoperatively reduced acromiohumeral distance shows a lower Constant-Murley score postoperatively. 3.3 A preoperatively higher grade defect arthropathy shows a lower Constant-Murley score postoperatively. 3.4 A preoperatively higher activity level shows a better result in the Constant-Murley Score postoperatively. 3.5 Preoperative positive clinical lag signs prove to be a predictor of poorer postoperative function. 3.6 Postoperative positive clinical lag signs correlate with a lower Constant-Murey Score and general patient dissatisfaction.	—

Measure

Time frame

1. Secondary hypothesis: In addition to the Constant-Murley score, there are further differences in the postoperative outcome between the two established replacement methods. 1.1 There are differences in the results of the clinical lag signs and general patient satisfaction. 1.2 The choice of the substitute procedure determines the progression of the defect arthropathy (classification according to Hamada). 1.3 The choice of the replacement procedure depends on the postoperative acromiohumeral distance and thus the radiological centering of the humeral head. Second hypothesis: The progression of a defect arthropathy as a result of non-reconstructable rotator cuff ruptures can be stopped with the aid of replacement methods. 2.1 The latency between the first clinical complaints and the time of operation has an influence on the progression of the defect arthropathy. 2.2 A preoperatively reduced acromiohumeral distance correlates with a greater postoperative progression of the defect arthopathy. 2.3 The postoperative acromiohumeral distance and thus the radiological centering of the humeral head correlates with a better functional result. 3. Secondary hypothesis: Clinical and radiological predictors of the postoperative outcome can be defined. 3.1 The latency between the first clinical complaints and the time of operation has an influence on the postoperative Constant-Murley score. 3.2 A preoperatively reduced acromiohumeral distance shows a lower Constant-Murley score postoperatively. 3.3 A preoperatively higher grade defect arthropathy shows a lower Constant-Murley score postoperatively. 3.4 A preoperatively higher activity level shows a better result in the Constant-Murley Score postoperatively. 3.5 Preoperative positive clinical lag signs prove to be a predictor of poorer postoperative function. 3.6 Postoperative positive clinical lag signs correlate with a lower Constant-Murey Score and general patient dissatisfaction.

—

Countries

Germany

Contacts

Public ContactMarvin Koth

Vivantes Humboldt-Klinikum BerlinUnfallchirurgie/Orthopädie

marvin.koth@vivantes.de030/130121655

Outcome results

None listed

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