Management of Proximal Humerus Fractures in Adults: a Clinical Trial

NCT06360887 | Not Yet Recruiting

• 1 other identifier: DRKS00030614
• Study Type: observational
• Target: 351
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective patient registry examining the outcome of three different treatment methods for proximal humerus fractures in elderlies: conservative treatment, open and minimal invasive surgical treatment.

Conditions

Shoulder Fractures

Outcome Measures

Primary Outcomes (1)

• Oxford Shoulder Score

  The primary endpoint of interest will be the Oxford Shoulder Score. The Oxford Shoulder Score is a patient-reported outcome measure developed to evaluate perceived pain and quality of life in subjects who received a shoulder operation. It can be used independently from the performed surgical treatment, excluding only surgical stabilisations. As the Italian province of Bolzano is bilingual (Italian and German), the Italian and German versions of the Oxford Shoulder Score shall be administered. Both versions of the Oxford Shoulder Score are valid and reliable, with high internal consistency and reproducibility. The Oxford Shoulder Score comprises 12 items with five possible answers each: pain (four items) and quality of life (eight items). The Oxford Shoulder Score contains two subscales, pain (20 points) and activities of daily living (40 points). Scores range from 0 to 60, with a higher score being consistent with increased disability.

  6, 12, and 24 months after surgery

Secondary Outcomes (2)

• The visual analogue scale

  6, 12, and 24 months after surgery

• Rate of complications

  6, 12, and 24 months after surgery

Study Arms (3)

Conservative

Participants allocated to conservative management will receive an orthosis (Gilchrist) for a minimum of four weeks. Using Gilchrist, the upper arm of the injured side is secured in abduction and internal rotation with the weight of the arm held by a ring around the patient's neck. At four weeks, plain radiographs of the shoulder will be conducted to ascertain the presence of the bony callous. If a bony callous is not present, the patient will maintain Gilchrist and plain radiographs of the shoulder will be conducted on a biweekly basis until a bony callous will be evident. If a bony callous is present, the patient will start a structured program of rehabilitation.

Procedure: Conservative

Open Reduction Internal Fixation

Participants allocated to ORIF will undergo surgery within 72 hours from the diagnosis using a standard deltopectoral approach. An angular stable plate is used in all patients following manufacturer instructions. No drains will be used.

Procedure: ORIF

Closed Reduction Percutaneous Pinning

Participants allocated to CRPP will be positioned in a beach chair under total anesthesia. The fracture is repositioned under fluoroscopic guidance using manual traction. The osteosynthesis is then done using Kirschner wires.The arm is placed into a Gilchrist for four weeks. At four weeks, plain radiographs of the shoulder will be conducted to ascertain the presence of the bony callous. If a bony callous is not present, the patient will maintain Gilchrist and plain radiographs of the shoulder will be conducted on a biweekly basis until a bony callous will be evident. If a bony callous is present, the Kirschner wires will be removed and the patient will start a structured program of rehabilitation.

Procedure: CRPP

Interventions

Conservative PROCEDURE

Conservative treatment

Conservative

ORIF PROCEDURE

Open surgery

Open Reduction Internal Fixation

CRPP PROCEDURE

Minimal invasive surgery

Closed Reduction Percutaneous Pinning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults presenting at our hospital with proximal humerus fractures that meet the inclusion and exclusion criteria

You may qualify if:

• adults who sustained a Proximal Humerus Fracture within the last week
• type of Proximal Humerus Fracture AO 11-(A2, A3), 11- (B1, B2, B3)
• BMI lower than 40 Kg/m2

You may not qualify if:

• stress fractures
• revision setting
• open fractures
• fractures associated with a neurologic lesion; previous fractures or bony procedure at the homolateral side
• patients unable to understand the procedure or instructions for rehabilitation
• terminal patients
• patients presenting multiple injuries

Sponsors & Collaborators

• Regional Hospital of Bolzano: lead

Study Sites (1)

Academic Hospital of Bolzano (SABES-ASDAA)

Bolzano, Trentino-Alto Adige, 39100, Italy

Location

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Filippo Migliorini, Dr.

  employee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malte Nikolas Witte, Dr.

CONTACT

00393885787726; maltewitte@posteo.de

Filippo Migliorini, Dr.

CONTACT

00393278751794; migliorini.md@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 11, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: when data is publicised
• Access Criteria: information will be shared if asked for with other researchers

Locations

IT (1)