Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02566018
Other study ID # 2014-310
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2015
Est. completion date December 31, 2019

Study information

Verified date May 2024
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is set to evaluate a proposed standard for the treatment of proximal humerus fractures


Description:

This study investigates the effect of routine treatment algorithm for proximal humerus fractures. All applied treatments are approved and reflect routine practice. The follow-up investigation as planned for this study is associated with only minimal risk for the concerned patients.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Age of 65 years or above - Proximal humerus fracture - Informed consent by the patient or legal representatives to participate in the study Exclusion Criteria: - More than one fracture, polytrauma - Suspicion of a pathological fracture in the context of known or unknown malignancy - Previous surgery of the proximal humerus on the same side - High energy trauma - Open Fracture - Insufficient German language skills

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
treatment/medical device
The new treatment algorithm was applied to all patients with proximal humerus fracture as from May 2013 onwards
standard
The old treatment algorithm was applied to all patients with proximal humerus fracture up to May 2013.

Locations

Country Name City State
Switzerland University Hospital Basel Basel Basel-Stadt

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Rikli D, Feissli S, Muller AM, Steinitz A, Suhm N, Jakob M, Audige L. High rate of maintaining self-dependence and low complication rate with a new treatment algorithm for proximal humeral fractures in the elderly population. J Shoulder Elbow Surg. 2020 J — View Citation

Schurch MA, Rizzoli R, Mermillod B, Vasey H, Michel JP, Bonjour JP. A prospective study on socioeconomic aspects of fracture of the proximal femur. J Bone Miner Res. 1996 Dec;11(12):1935-42. doi: 10.1002/jbmr.5650111215. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary personal dependency status A simple four point rating is used at the time of injury (for the premorbid state) and at 6 months to demonstrate the impact of the injury (including its treatment) on the ability to return to the former social environment and degree of self-dependency. 6 months
Secondary range of motion 6 months
Secondary Shoulder pain and disability index (SPADI) The SPADI is a patient-based questionnaire containing 15 questions about pain and activities of daily living that must be answered by the patient on a scale of 0-10 (0 = no pain / no difficulties to 10 = Worst pain / activity). Five questions relate to the pain and 8 questions relate to the function in daily activities, both subscores are combined and converted to the total score to 0 (= lowest score) to 100 (= best result). A validated German version is available 6 months
Secondary SSV The Subjective Shoulder Value (SSV) is based on a single question that is answered subjectively by the patients. The English formulation of this question is: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?" 12 It is an easily administered measure of shoulder function. 6 months
Secondary General health using EuroQuality of life (EQ)-5D-5L visual analogue scale (VAS) The gain in quality of life within two years after surgery is assessed using the generic Quality of Life (QoL) EuroQoL EQ-5D-5L instrument. 6 months
Secondary Quality of life (utilities) derived using EQ-5D-5L Using the EQ-5D-5L instrument patients are asked to report on their general health status on a VAS scale from 0 (worst possible health) to 100 (best possible health). 6 months
See also
  Status Clinical Trial Phase
Terminated NCT02861495 - Humeral Compression/Distraction Device N/A
Completed NCT03610113 - Reverse Or Nothing For Complex Proximal Humeral Fractures N/A
Completed NCT01051869 - Simple Decompression Versus Anterior Transposition of the Ulnar Nerve N/A
Recruiting NCT03796572 - Regional Blocks for Lateral Condyle Fractures Phase 4
Terminated NCT03724422 - HO Prophylaxis Therapy for Distal Humerus Fractures N/A
Completed NCT02863289 - The Outcomes of Proximal Humerus Fractures in Children
Completed NCT00772850 - Rotator Cuff Injury in Antegrade Locked Nailing for Humeral Fractures N/A
Completed NCT01984112 - Proximal Humerus Fractures: Randomized Study Between Locking Nails and Locking Plates for Neer 2 and 3 Parts N/A
Completed NCT02733666 - Internal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children Phase 1
Completed NCT02640027 - The Use of Telemedicine Tool in Supracondylar Humerus Fractures in Children N/A
Completed NCT02170545 - CT Imaging Evaluation of Humerus Fractures
Withdrawn NCT02091492 - Teriparatide for Fracture Repair in Humans Phase 3
Completed NCT00698867 - A Clinical Investigation of the Discovery™ Elbow System N/A
Withdrawn NCT01812863 - Pain Management in Children Undergoing Supracondylar Humerus Fracture Repair N/A
Completed NCT00358787 - Management of Displaced Supracondylar Fractures of the Humerus Using Lateral vs. Crossed K-wires N/A
Recruiting NCT05118087 - Comparison of Bracing With Co-aptation Splinting for the Initial Treatment of Acute Humeral Shaft Fractures: The COBRAS Trials N/A
Completed NCT04538118 - Relationship of Patient-Specific Functional Scale With Shoulder Functions: A Prospective Study
Completed NCT04216017 - Glenohumeral Cortisone Injection Phase 2
Not yet recruiting NCT03358173 - Operative Plate Fixation Versus Conservative Treatment for Acute, Displaced Fractures of Humeral Shaft N/A
Not yet recruiting NCT01017289 - Intramedullary Fixation of Humerus Fractures N/A