Effectiveness Between Two Surgical Techniques for Reconstruction of Humeral Proximal Extremity Fractures

A02.835.232.087.090.400.400 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075476
• Other study ID #: FRALUX-34
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: August 6, 2016

Study information

• Verified date: April 2020
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 6, 2016
• Est. primary completion date: August 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• A02.835.232.087.090.400.400
• Fractures, Bone

Intervention

Procedure:
• Hemiarthroplasty

• reverse arthroplasty

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Carlos Alvarez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness Will be Measured for AMERICAN SHOULDER AND ELBOW (ASES) Score	changes en ASES (AMERICAN SHOULDER AND ELBOW) score will be measured.; The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. This questionary includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.	36 months
Primary	Effectiveness Will be Measured for Constant Score	changes in Constant score will be measured.; The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury.; The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.	36 months
Primary	Effectiveness Will be Measured for DASH (Disabilities of the Arm, Shoulder and Hand) Score	changes in DASH (Disabilities of the Arm, Shoulder and Hand) score will be measured.; The Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure is a 30-item, self-report questionnaire designed to assess the patient's health status during the previous week. The items enquire about the degree of difficulty in performing different physical activities because of arm, shoulder and hand problems (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (five items) and the impact of the problem on social functioning, work, sleep and self-image (four items). Each item has five response options. The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)	36 months