Prospective randomized study on the outcome after cemented vs. uncemented reverse total shoulder arthroplasty for proximal humerus fractures

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039893

Enrollment

160

Registered

2026-04-30

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

proximal humerus fracture

Interventions

Group 1: Patients with proximal humerus fractures receive a reverse total shoulder arthroplasty with cemented humeral stem fixation following randomization as part of standard surgical care. The surg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Proximal humeral fracture with an indication for implantation of a reverse total shoulder arthroplasty, in which—based on the fracture configuration—both cemented and uncemented fixation are feasible Age = 18 years Signed informed consent form

Exclusion criteria

Exclusion criteria: Minor age (< 18 years) Lack of capacity to give informed consent Pathological fracture Prior surgeries or pre-existing pathologies of the affected shoulder

Design outcomes

Primary

Measure	Time frame
WHAT: Functional outcome of the shoulder measured using the Constant Score (CS; Constant-Murley Score). WHEN: Assessment at the following time points: preoperative baseline (T0) 6 weeks postoperatively (T1) 3 months postoperatively (T2) 6 months postoperatively (T3) 12 months postoperatively (T4, primary endpoint time point) HOW: The Constant Score (CS; Constant-Murley Score) is assessed during standardized clinical follow-up examinations. This validated clinical score evaluates shoulder function including pain, activities of daily living, range of motion, and strength.	—

Measure

Time frame

WHAT: Functional outcome of the shoulder measured using the Constant Score (CS; Constant-Murley Score). WHEN: Assessment at the following time points: preoperative baseline (T0) 6 weeks postoperatively (T1) 3 months postoperatively (T2) 6 months postoperatively (T3) 12 months postoperatively (T4, primary endpoint time point) HOW: The Constant Score (CS; Constant-Murley Score) is assessed during standardized clinical follow-up examinations. This validated clinical score evaluates shoulder function including pain, activities of daily living, range of motion, and strength.

—

Secondary

Measure	Time frame
WHAT: Function and range of motion: Shoulder range of motion (ROM) Constant Score (CS; Constant-Murley Score), age- and sex-adjusted DASH (Disabilities of the Arm, Shoulder and Hand) ASES (American Shoulder and Elbow Surgeons Score) Pain: Pain intensity measured using the VAS (Visual Analog Scale) and NAS (Numeric Analog Scale) Quality of life: SF-36 (Short Form-36 Health Survey) EQ-5D (EuroQol 5 Dimensions Questionnaire) Radiological outcomes: Implant loosening (radiolucent lines according to Gruen zones) Stem subsidence (> 3 mm) and migration Stress shielding (bone resorption according to Inoue classification) Tuberosity healing (greater and lesser tuberosity) Secondary osseous complications (e.g., scapular notching according to Sirveaux classification, periprosthetic fractures, acromial fractures) Complications and revisions: Wound healing disorders, infections (periprosthetic joint infection, PJI) Vascular and nerve injuries Thromboembolic events (deep vein thrombosis, pulmonary embolism) Prosthetic dislocation/instability Aseptic loosening Revision rate, time to revision, and reasons for revision WHEN: Assessment at the following time points: preoperative baseline (T0) 6 weeks (T1) 3 months (T2) 6 months (T3) 12 months (T4) 24 months (T5) annually up to 5 years (T6–T8) HOW: Clinical examination and standardized functional scores (Constant Score, DASH, ASES) Patient-reported outcome measures (SF-36, EQ-5D, VAS, NAS) Radiological follow-up using standard X-rays in three planes (anteroposterior, axial, and Y-view) Documentation of complications and revision procedures based on clinical and radiological findings	—

Measure

Time frame

WHAT: Function and range of motion: Shoulder range of motion (ROM) Constant Score (CS; Constant-Murley Score), age- and sex-adjusted DASH (Disabilities of the Arm, Shoulder and Hand) ASES (American Shoulder and Elbow Surgeons Score) Pain: Pain intensity measured using the VAS (Visual Analog Scale) and NAS (Numeric Analog Scale) Quality of life: SF-36 (Short Form-36 Health Survey) EQ-5D (EuroQol 5 Dimensions Questionnaire) Radiological outcomes: Implant loosening (radiolucent lines according to Gruen zones) Stem subsidence (> 3 mm) and migration Stress shielding (bone resorption according to Inoue classification) Tuberosity healing (greater and lesser tuberosity) Secondary osseous complications (e.g., scapular notching according to Sirveaux classification, periprosthetic fractures, acromial fractures) Complications and revisions: Wound healing disorders, infections (periprosthetic joint infection, PJI) Vascular and nerve injuries Thromboembolic events (deep vein thrombosis, pulmonary embolism) Prosthetic dislocation/instability Aseptic loosening Revision rate, time to revision, and reasons for revision WHEN: Assessment at the following time points: preoperative baseline (T0) 6 weeks (T1) 3 months (T2) 6 months (T3) 12 months (T4) 24 months (T5) annually up to 5 years (T6–T8) HOW: Clinical examination and standardized functional scores (Constant Score, DASH, ASES) Patient-reported outcome measures (SF-36, EQ-5D, VAS, NAS) Radiological follow-up using standard X-rays in three planes (anteroposterior, axial, and Y-view) Documentation of complications and revision procedures based on clinical and radiological findings

—

Countries

Germany

Contacts

Public ContactEvi Fleischhacker

LMU Klinikum München

evi.fleischhacker@med.uni-muenchen.de089 4400 82234

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026