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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00612391
Acronym
HURA
Enrollment
79
Registered
2008-02-11
Start date
2007-11-30
Completion date
2020-11-30
Last updated
2021-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Closed Fracture Proximal Humerus, Neck

Keywords

humerus fracture

Brief summary

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

Interventions

PROCEDURELateral minimally invasive approach (plate fixation)

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.

PROCEDUREDeltopectoral approach (plate fixation)

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.

Sponsors

Centre de recherche du Centre hospitalier universitaire de Sherbrooke
CollaboratorOTHER
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
CollaboratorOTHER
Université de Montréal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Humeral surgical neck fracture, Neer II valgus-type Neer III 2. Patient willing to participate in the study 3. Patient available for follow-up through at least two years 4. Patient with acceptable preoperative medical clearance and free of, or treated for, medical conditions that would pose excessive operative risk 5. Patient fluent in French and/or English and able to understand his/her role in the study

Exclusion criteria

1. Inflammatory arthritis 2. Prior shoulder pathology 3. Active local or systemic infection 4. Neurologic or musculoskeletal disease that may adversely affect mobility 5. Participation in any other pharmaceutical, biologic or medical-device clinical investigation 6. Severe documented psychiatric disease 7. Severe ipsilateral elbow or wrist disease 8. Fracture resistant to reduction attempts through the minimally invasive lateral approach

Design outcomes

Primary

MeasureTime frame
Quick DASH3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.

Secondary

MeasureTime frame
SF-12V2 Questionnaire Constant Shoulder Score The Patient Scar Assessment Scale Complication rate3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026