Hanover Humerus Registry

NCT03060876 | Unknown DMC

• 1 other identifier: TS-1MHH2016-HHR
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This register study collects data of patients with proximal humerus and humerus shaft fractures to monitor the healing process by assessing shoulder function and quality of life according to the treatment method (operative or conservative management).

Conditions

Proximal Humerus Fracture

Keywords

shoulder fractures; humeral fractures; operative therapy; conservative therapy; range of motion, articular; quality of life; proximal

Outcome Measures

Primary Outcomes (4)

• Constant Shoulder Score (CS) (change over time)

  The CS is a commonly used outcome measure for assessing the outcomes of the treatment of shoulder disorders including the pain score, functional assessment, range of motion and strength measures. In week 6, 52 and in the yearly follow ups for comparison reasons the investigators also assess the CS of the not affected shoulder. Reported value is the impaired shoulder-functionality in percent. 100% are equivalent to an unimpaired shoulder function.

  following a aftercare treatment plan with follow ups after 6,12, 24, 52 weeks in the first year; then through study completion, an average of 1 year

• DASH (change over time)

  The Disabilities of the Arm, Shoulder and Hand (DASH) scoring system was developed to assess the level of disability for any patient with any condition affecting the upper limb by covering domains including symptoms, physical function, social function and psychological function.

  following a aftercare treatment plan with follow ups after 1,3,6,12, 24, 52 weeks in the first year; then through study completion, an average of 1 year

• Health related quality of life: EuroQoL (EQ-5D-3L+5L) (change over time)

  The EQ-5D-3L/5L is a standardized instrument for use as a measure of health outcome. It was designed for self-completion covering mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Furthermore, health state is indicated by a Visual Analog Scale (VAS). EQ-5D assesses the health status of the patients in an one-dimensional number (1-3/1-5).

  following a aftercare treatment plan with follow ups after 1,3,6,12, 24, 52 weeks in the first year; then through study completion, an average of 1 year

• Subjective Shoulder Value (SSV) (change over time)

  The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.

  following a aftercare treatment plan with follow ups after 1,3,6,12, 24, 52 weeks in the first year; then through study completion, an average of 1 year

Secondary Outcomes (2)

• healing process (change over time)

  following a aftercare treatment plan with follow ups after 1, 3, 6,12, 24, 52 weeks in the first year; then through study completion, an average of 1 year

• general health conditions

  Baseline week 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with proximal humerus fracture

You may qualify if:

• patients with trauma-related proximal humerus and humerus shaft fracture
• cognitively able to fill out a questionaire
• signed informed consent

You may not qualify if:

• patients with oncological-related proximal humerus and humerus shaft fracture
• cognitively not able to fill out a questionaire
• no informed consent

Sponsors & Collaborators

• Hannover Medical School: lead
• Traumastiftung: collaborator

Study Sites (1)

Hanover medical school /trauma surgery

Hanover, Lower Saxony, Germany

RECRUITING

Related Publications (1)

• Razaeian S, Hawi N, Zhang D, Liodakis E, Krettek C. Conservative treatment of displaced isolated proximal humerus greater tuberosity fractures: preliminary results of a prospective, CT-based registry study. Eur J Trauma Emerg Surg. 2022 Dec;48(6):4531-4543. doi: 10.1007/s00068-020-01453-7. Epub 2020 Sep 15.

  PMID: 32930807 DERIVED

MeSH Terms

Conditions

Shoulder Fractures; Humeral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries; Arm Injuries

Study Officials

• Christian Krettek, Prof. Doc.

  Hanover medical school trauma surgery// trauma foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bianca Kramer, B.Sc.

CONTACT

+49 511 532 8427; kramer@traumastiftung.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: February 23, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2025
• Last Updated: February 23, 2017

Record last verified: 2016-06

Locations

DE (1)