Clinical trial NCT02075476: Effectiveness Between Two Surgical Techniques for Reconstruction of Humeral Proximal Extremity Fractures
Official title: Prospective, Randomized and Double Blind Study of Parallels Groups for Evaluating the Effectiveness Between Two Surgical Techniques for Reconstruction of Humeral Proximal Extremity Fractures in Three or Four Fragments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: A02.835.232.087.090.400.400
Keywords: Fracture-luxation
humeral proximal extremity
Hemiarthroplasty
reverse Arthroplasty
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of two surgical techniques for the treatments of proximal extremity humeral fractures and fractures luxation in three o four fragments of Neer's classification.

Detailed description: Proximal extremity humeral fractures present high prevalence. It's estimated about 10% of all fractures. Their incidence is 6,6/1000 people-year and this amount increases from 40 years old. The majority are successfully treated with immobilization and rehabilitation. The surgical treatment is recommended in case of displacement. In elderly population with fractures types three or four of Neer's classification there is no consensus on which technique is the best surgical option. Classically hemiarthroplasty has been widely performed as a reconstruction method but its outcomes in old patients are unclear due to the bad bone quality and joint features. Recently some authors recommend the reverse arthroplasty in patients over 70 years old . The aim of this study is to compare the results between Hemiarthroplasty and reverse arthroplasty in patients over 70 years old. As far as the investigators are concerned there's no published studies like this.

Eligibility criteria: Inclusion Criteria:

* Patients with humeral proximal extremity fracture or fracture luxation in three or four fragments of Neer's classification.
* Patient 70 years older
* Signed informed consent.

Exclusion Criteria:

* Any condition to make worse the functional recovery or avoid the patient collaboration with the rehabilitation program ( cognitive disability, neurological pathology...)

  * Glenohumeral osteoarthritis
  * Inflammatory arthropathies
  * Previous cuff arthropatyy
  * High surgical or anesthesia risk
  * Any disease or condition that the investigator finds decisive for exclusion.

Primary outcomes:
measure: Effectiveness Will be Measured for AMERICAN SHOULDER AND ELBOW (ASES) Score
timeFrame: 36 months
measure: Effectiveness Will be Measured for Constant Score
timeFrame: 36 months
measure: Effectiveness Will be Measured for DASH (Disabilities of the Arm, Shoulder and Hand) Score
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
Study officials:
affiliation: Hospital General Universitario Gregorio Marañon
name: Carlos Alvarez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.