Clinical trial NCT01984112: Proximal Humerus Fractures: Randomized Study Between Locking Nails and Locking Plates for Neer 2 and 3 Parts
Official title: Proximal Humerus Fractures: Randomized Study Between Intramedullary Locking Nails and Locking Plates for Neer 2 and 3 Parts Displaced Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Humerus
Proximal Humeral Fracture
Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries
Keywords: Humerus
fracture
nail
plate
tuberosity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is to determine whether the technique of intramedullary locking nail presents clinical results comparable to the technique of locking plates, based on the Constant Score.


Eligibility criteria: Inclusion Criteria:

* Fracture with less than 21 days;
* Fractures of the proximal humerus classified as 2 or 3 parts of Neer, with involvement of the humeral head and one of the tuberosities;
* Fracture with unacceptable deviation for the non-surgical treatment, according to the criteria of Neer Neer: fractures with deviation greater than 45 ° or 1 cm for the fragment of the humeral head and fractures with a deviation of the tuberosity greater than 0.5 cm;
* Closed fractures;

Exclusion Criteria:

* Characteristics of the fracture:

  * fracture between the greater tubercle and the smaller, independent of the deviation;
  * Isolated fracture of the greater or lesser tuberosity
  * 4-part fractures of Neer;
  * Fracture involving the articular surface of the humeral head;
  * Fracture-dislocation of the proximal humerus
* Other criteria:

  * Neurological injuries in the affected limb;
  * previous surgery on the affected shoulder;
  * associated fractures in the affected limb;
  * pathologic fractures;
  * lesions of the rotator cuff tendons previously diagnosed;
  * Psychiatric illnesses or inability to understand preoperative questionnaires;
  * Active infection or previous infection on the shoulder;

Primary outcomes:
measure: Shoulder function, pain, strength and range of motion, measured by Constant-Murley Score
timeFrame: 12 months
Secondary outcomes:
measure: Superior limb function, measured by DASH score
timeFrame: 12 months
measure: Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by UCLA score
timeFrame: 12 months
measure: Shoulder function, pain, strength and range of motion compared with non-injuried shoulder, measured by Individual Relative Constant-Murley Score
timeFrame: 12 months
measure: Number of patients with complications
timeFrame: 12 months
Other outcomes:
measure: Post-operative integrity of the rotator cuff, evaluated by ultrasonography
timeFrame: 6 months
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Ortopedia e Traumatologia
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Mauro EC Gracitelli, 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.