Influence of Local Bone Status on Complications After Surgical Treatment of Proximal Humerus Fractures

NCT01143675 | Completed

• 1 other identifier: FFOB-Hum
• Study Type: observational
• Target: 148
• Locations: 4 countries
• Sites: 10

Brief Summary

The purpose of this study is to evaluate if poor bone quality increases the risk of specific types of treatment complications in patients with proximal humerus fractures treated with open reduction and angle-stable plates (Proximal Humeral Internal Locking System - PHILOS).

Conditions

Proximal Humeral Fractures; Poor Bone Quality; Treatment Complications

Keywords

Humerus fractures; Tomography, x-ray computed; Bone and bones; Orthopedic fixation devices; Surgery; Postoperative complications; Osteoporosis; Intraoperative complications; Bone density; Radiography, dual-energy scanned projection

Outcome Measures

Primary Outcomes (1)

• Local bone quality-related complication

  The qualifying events are those involving either directly the local bone and fracture or the implant and its surgical application whether they are anticipated or not.

  From enrollment to 12 months postoperative

Secondary Outcomes (27)

• Bone mineral density at the distal radius by DXA

  until 6 week postoperative

• Occurence of any complication

  6 weeks

• Occurence of any complication

  3 months

• Occurence of any complication

  12 months

• Range of motion

  6 weeks

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Orthopedic and trauma clinics

You may qualify if:

• Radiologically confirmed closed fracture (within 10 days) of the proximal humerus
• All dislocated (mod. Neer) proximal humerus fractures except dislocated fractures of the greater and lesser tuberosity
• Primary fracture treatment with a PHILOS-plate
• Age equal greater than 50 and equal younger than 90 years
• Normal function of both shoulders (pre-trauma) according to age
• Monotrauma
• Willing and able to give written informed consent to participate in the study
• Willing and able to participate in the study follow-ups according to the CIP
• Willing and able to comply with the postoperative management program
• Able to understand and read country national language

You may not qualify if:

• Open proximal humerus fractures
• Concomitant contralateral proximal humerus fracture
• Previous proximal humerus fracture on either side after the age of 25
• Time to operation \> 10 days
• Polytrauma
• Cuff-arthropathy of the contralateral proximal humerus
• Associated nerve or vessel injury
• Regular systemic therapy with corticosteroids due to chronic disease
• Legal incompetence
• Patient received radio- or chemotherapy prior to, during or within the last year
• Currently active cancer
• Recent history of substance abuse (i.e. recreational drugs, alcohol)
• Prisoner
• Currently involved in a pharmaceutical clinical study§
• Has a disease process that would preclude accurate evaluation (e.g. neuromuscular or rheumatic disease, significant psychiatric or metabolic disorders)

Sponsors & Collaborators

• AO Clinical Investigation and Publishing Documentation: lead

Study Sites (10)

Medizinische Uni Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Queen Mary Hospital

Hong Kong, China

Location

Klinikum rechts der Isar der TU München

Munich, Bavaria, 81675, Germany

Location

Ev. Diakoniewerk Friederikenstift

Hanover, Lower Saxony, 30169, Germany

Location

Campus Virchow-Klinikum, Charité

Berlin, 13353, Germany

Location

Centre Hosp Univ Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Kantonsspital

Lucerne, 6000, Switzerland

Location

Stadtspital Triemli

Zurich, 8063, Switzerland

Location

Related Publications (1)

• Goldhahn S, Kralinger F, Rikli D, Marent M, Goldhahn J. Does osteoporosis increase complication risk in surgical fracture treatment? A protocol combining new endpoints for two prospective multicentre open cohort studies. BMC Musculoskelet Disord. 2010 Nov 9;11:256. doi: 10.1186/1471-2474-11-256.

  PMID: 21062463 DERIVED

Related Links

• Non profit organization dedicated to improving the care of patients with musculoskeletal injuries and their sequelae through research, development, education and quality assurance in the principles, practice, and result of fracture treatment.

MeSH Terms

Conditions

Shoulder Fractures; Humeral Fractures; Postoperative Complications; Osteoporosis; Intraoperative Complications

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries; Arm Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Franz Kralinger, MD

  Medizinische Uni Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 14, 2010
• Study Start: March 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

CN (1); AU (1); CH (5); DE (3)