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Completed

NCT Number: NCT00612391

Lateral Mini Approach vs Anterior Approach for Plating of Proximal Humerus Fracture

A prospective randomized clinical trial is proposed to compare the plate fixation of proximal humerus fractures using a minimally invasive lateral approach and the traditional anterior approach.Forty five patients will be assigned to each approach (total of 90 patients) and will be assessed 7 times over a two-year period. The trial's primary objectives will be to demonstrate the efficacy of the plating technique in terms of speed of recuperation of function. The Quick DASH will be used for evaluation of function.The study will also examine secondary end-points of pain, range of motion, esthetic satisfaction and radiographic outcome, as assessed by the components of the Constant Score3,4, SF-12V2 Questionnaire, and Patient Scare Assessment Scale Questionnaire. Furthermore, the assessment of safety will be based on the rates of all reported complications and adverse events at 2 years

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Key information

Conditions

Closed Fracture Proximal Humerus, Neck Arm Injuries Fractures, Bone Humeral Fractures Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Sacré-Coeur

Montreal, Quebec, H4J1C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Humeral surgical neck fracture, Neer II valgus-type Neer III
  • Patient willing to participate in the study
  • Patient available for follow-up through at least two years
  • Patient with acceptable preoperative medical clearance and free of, or treated for, medical conditions that would pose excessive operative risk
  • Patient fluent in French and/or English and able to understand his/her role in the study

Exclusion criteria

  • Inflammatory arthritis
  • Prior shoulder pathology
  • Active local or systemic infection
  • Neurologic or musculoskeletal disease that may adversely affect mobility
  • Participation in any other pharmaceutical, biologic or medical-device clinical investigation
  • Severe documented psychiatric disease
  • Severe ipsilateral elbow or wrist disease
  • Fracture resistant to reduction attempts through the minimally invasive lateral approach

Treatment and study plan

Lateral minimally invasive approach (plate fixation)

Procedure

A longitudinally oriented, 4-cm incision will be made laterally starting at the acromion. The deltoid will be split proximally at the most strategic location (vis-à-vis the fracture), and after the deltoid is bluntly elevated from the humerus more distally the axillary nerve will be identified by digital palpation. The nerve is easily identified posteriorly as it emerges from the quadrilateral space. With a finger maintained on the nerve for protection, the plate will be inserted onto the lateral side of the proximal humerus and fixed according to the described technique. A second, 2-cm longitudinal incision will then be made further distally for diaphyseal screw placement. This incision is well distal to the course of the axillary nerve.

Deltopectoral approach (plate fixation)

Procedure

Anterior, Delto-Pectoral Approach - A 10-cm incision will be made over the deltopectoral groove, starting at the coracoid process proximally. As the clavipectoral fascia is incised, the cephalic vein will be identified and retracted laterally with the deltoid muscle. The pectoralis major as well as the conjoint tendon will be retracted medially, and the long head of the biceps tendon will be identified and used as a guide for achieving an anatomic reduction of the different fracture parts. Next, internally rotating the humerus will allow access to the lateral side of the proximal humerus, on which the plate will then be fixed according to the described technique.

Primary outcomes

  1. Quick DASH

    Time frame: 3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.

Secondary outcomes

  1. SF-12V2 Questionnaire Constant Shoulder Score The Patient Scar Assessment Scale Complication rate

    Time frame: 3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Collaborators

  • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Registry information

Official study title

A Randomized Clinical Trail Comparing a Lateral Minimally Invasive Approach and the Traditional Anterior Approach for Plating of Proximal Humerus Fractures

Acronym: HURA

Important dates

Study start
2007
Primary completion
2019
Study completion
2020
First posted
Feb 11, 2008
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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