Clinical trial NCT03060876: Hanover Humerus Registry
Official title: Prospective Register Study of Patients After Proximal Humerus and Humerus Shaft Fracture for Data Collection of Healing Process, Quality of Life and Shoulder Function According to the Treatment Method - Hanover Humerus Register (HHR)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Proximal Humerus Fracture
Keywords: shoulder fractures
humeral fractures
operative therapy
conservative therapy
range of motion, articular
quality of life
proximal
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Traumastiftung
First posted: 2017-02-23
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with proximal humerus fracture

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).

Detailed description: This prospective data collection of patients with proximal humerus and humerus shaft fractures in a lifelong aftercare treatment plan is for analyzing the healing process in one patient and compared in the whole cohort.

According to actual scientific and clinical issues can this data collection be a basis in optimizing the treatment method.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Constant Shoulder Score (CS) (change over time)
timeFrame: 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
measure: DASH (change over time)
timeFrame: 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
measure: Health related quality of life: EuroQoL (EQ-5D-3L+5L) (change over time)
timeFrame: 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
measure: Subjective Shoulder Value (SSV) (change over time)
timeFrame: 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:
measure: healing process (change over time)
timeFrame: 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
measure: general health conditions
timeFrame: Baseline week 1
Other outcomes:
Locations:
city: Hanover
country: Germany
facility: Hanover medical school /trauma surgery
state: Lower Saxony
Study officials:
affiliation: Hanover medical school trauma surgery// trauma foundation
name: Christian Krettek, Prof. Doc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.