Topics

Two- Part Proximal Humerus - Conservative vs Operative

2019-10-02 07:21:32 | BioPortfolio

Summary

The proximal humerus fracture (PHFs) is the third most common fracture type in the elderly, and represents 5% of the overall fractures. The incidence is increasing. The purpose of the project is to compare surgical and conservative management of two- part PHFs in light of radiological, economical and clinical outcome. Do the participants between 60 and 85 years of age with displaced two-part PHFs fare better or worse after surgery compared to non-operative treatment?

Description

The study-design is a single center single blinded randomized controlled trial (RCT) with 2 arms. Patients admitted to Akershus University Hospital (Ahus) with a displaced two-part proximal humeral fracture of OTA/ AO group 11A2 or 11A3 in need of surgical treatment will be randomly allocated to two groups; conservative/ non-operative treatment or open reduction and internal fixation (ORIF).

All following aims evaluated at controls at 6, 12, 26 and 52 weeks. The 6 months and 1 year controls will additionally be conducted by independent physiotherapists. The other controls are conducted by the treating surgeons. The physiotherapists will be blinded of chosen treatment, the patients wearing a t-shirt covering the shoulder at the consultations, hence single blinded RCT.

Primary aim: Functional outcome as evaluated by the Quick DASH (Disability of the arm, shoulder and hand) score at controls.

Preoperative evaluation:

The project participants will supervise and evaluate the data. General history, including; mechanism of injury, occupation, pre-existing medical conditions and medication, smoking history, American Society of Anesthesiologists Classification (ASA classification), BMI, hand dominance. At inclusion, the patient will be asked to fill out quick-Dash, Visual Analog scale (VAS), EQ-5D to determine the baseline-characteristics.

Postoperative evaluation:

Evaluation of postoperative radiographs for reduction of fracture and possible errors of the operative technique by the project participants and a radiologist.

Secondary aims:

1. Initial radiographic examination with standardized radiograph projections; true anterio-posterior projection and scapula projection pre- and post-operative. Registration of radiological complications defined by a reduction of Head-Shaft-Angle (HSA) of ≥10⁰ in frontal plane, screw penetration/cut-out, screw failure or failure of the osteosynthesis on radiographs. Evaluation of fracture healing/ non-union.

2. Evaluation of postoperative reduction: Reduction of tubercles, rotation of caput, re-establishment of medial support, position of calcar screws and distance from screws to cartilage in x-rays. Computer-tomographic scans are standard pre-operative practice at our institution. The problem of intra- and inter-observer reproducibility is a well-known confounder of fracture classification in proximal humeral fractures and CT scans will help clarify classification (19, 20) and fracture configuration. CT scan postoperatively will be taken within few days after surgery (Only in Stratum 1).

3. Qualitative Computed Tomography (QCT) is an alternative method to measure Bone Marrow Density (BMD) using a Hydroxyapatite plate/ a phantom. This is a flat plate placed under the shoulder during ordinary CT scanning. Several studies have demonstrated an association between the QCT measurements and risk of fragility fractures, so BMD will be assessed.

4. Functional outcome of surgical treatment as evaluated by Constant score by independent physiotherapists during follow-up. Measurement of strength according to recommendations given by the European Society of Shoulder and Elbow Surgeons ESSSE (http://secec.org/).

5. Functional outcome evaluated by Oxford Shoulder score, which is a validated patient-reported outcome measure. A shoulder-specific instrument designed to assess the outcome of all shoulder surgeries.

6. EQ-5D, a generic measure of health status that provide a simple descriptive profile used in clinical evaluation of health care. EQ-5D is recommended for use in cost-effectiveness in Health and Medicine and by the Washington panel of Pharmacoeconomics and outcomes research (ISPOR) task.

7. Health economic registration; length of hospital-stay, sick leaves, use of physiotherapy, appointments at general practitioners, extra controls at in-patient orthopedic clinic, removal of plate or nail, extra surgeries.

8. Monitoring complications such as deep or superficial infection, reoperations, avascular necrosis, non-union, nerve or vessel-damage.

In the literature, the following risk factors for failure of the osteosynthesis, Avascular necrosis (AVN) or chance of poor functional outcome are outlined; the factors will be examined as subgroups to see whether they are representative also for our population:

- A non-adequately reduced fracture. Evaluated in postoperative radiographs. Malalignment?

- Not adequately positioning of implant

- Degree of medial comminution and medial hinge (the amount of metaphyseal bone attached to the anatomic head fragment at trauma.

- Is sufficient medial support achieved in our patients, and if not, does the construction fail?

- Varus subsidence, measured as reduced Head shaft angle (HSA) (>10 degrees) during follow up

- Fixation in varus, HSA <120 or HSA <110 .

- Enough contact between head and shaft for healing?

- Age: Increasing age predisposes osteosynthesis failure and reduced function, probably because of decreasing bone density in proximal humerus in older age. The examiners want to examine whether there is a cut-off in age, in example 60, 65, 75, 80 or 85 years of age.

- Valgus >45 or Varus <30, which fracture is the worst?

Patients allocated to the conservative group may be offered surgical treatment if the fracture changes/ dislocates, in example no contact between the fracture ends if the patients activities of daily living (ADL) is greatly affected or pain is disproportionately

Study Design

Conditions

Proximal Humerus Fracture

Intervention

Open reduction internal stabilisation (ORIF)

Location

Akershus University Hospital
Lørenskog
Oslo
Norway
0587

Status

Not yet recruiting

Source

University Hospital, Akershus

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-02T07:21:32-0400

Clinical Trials [1336 Associated Clinical Trials listed on BioPortfolio]

Reverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3&4 Part Proximal Humerus Fractures

Will patients who suffer complex humerus fractures have better functional outcomes and less implant failure with shoulder replacement (reverse total shoulder arthroplasty, RTSA) compared t...

LPHP-Philos-PHN Conservative Treatment

The aim of the study is to compare the results regarding fracture healing and functional outcome after the treatment of proximal humeral fractures with the four different treatment metho...

Proximal Humerus Fractures: A Retrospective Analysis

The purpose of this study is to evaluate preoperative objective measurements of patients with a proximal humerus fracture and operative objective measurements to determine if there is any ...

Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures

This is a randomized control trial comparing the outcome of ORIF (open reduction and internal fixation) with EHA (elbow hemiarthroplasty) for distal humeral fractures in patients aged 50 y...

PMCF Study of the A.L.P.S. Proximal Humerus Plating System

This study is a multicenter, prospective, non-randomized, non-controlled post-market clinical follow-up study. The primary objective of this study is to confirm the safety and performance ...

PubMed Articles [13216 Associated PubMed Articles listed on BioPortfolio]

Simultaneous ORIF for bilateral comminuted proximal humerus fractures: Case report in an elderly patient.

Bilateral proximal humerus fractures are rather rare and occur due to high energetic traumas in young patients and even low energetic traumas in older patients having osteoporosis. Open reduction and ...

Complications and Long-Term Outcomes of Open Reduction and Plate Fixation of Proximal Humeral Fractures.

The optimal treatment of complex proximal humeral fractures in adults remains controversial. We evaluated the risk of complications and the long-term outcomes in patients with a severely displaced fra...

Capitellum Fracture Open Reduction and Internal Fixation With Headless Screws.

Partial articular fractures involving the capitellum represent an injury to the lateral column of the distal humerus. Capitellum open reduction and internal fixation restores this portion of the dista...

Radial-to-Axillary Nerve Transfer Resolves Symptoms of Axillary Nerve Injury Due to Proximal Humerus Fracture-Dislocation in an Elderly Patient Treated With Hemiarthroplasty.

Proximal humerus fractures in elderly patients are a common injury that can often be treated nonoperatively. However, surgery is indicated with some fracture patterns. Arthroplasty is an attractive op...

Outcomes of knee replacement in patients with posttraumatic arthritis due to previous tibial plateau fracture.

Tibial plateau fractures are routinely treated with open reduction internal fixation (ORIF); however, the long-term results of ORIF are unclear. The purpose of the current study is to evaluate outcome...

Medical and Biotech [MESH] Definitions

The use of internal devices (metal plates, nails, rods, etc.) to hold the position of a fracture in proper alignment.

Restoration of normal alignment of a fractured bone via an OPERATIVE SURGICAL PROCEDURE.

Fracture in the proximal half of the shaft of the ulna, with dislocation of the head of the radius.

The internal lateral ligament that travels from the medial aspect of the ELBOW uniting the distal aspect of the HUMERUS to the proximal aspect of the ULNA.

A cartilage-capped benign tumor that often appears as a stalk on the surface of bone. It is probably a developmental malformation rather than a true neoplasm and is usually found in the metaphysis of the distal femur, proximal tibia, or proximal humerus. Osteochondroma is the most common of benign bone tumors.

More From BioPortfolio on "Two- Part Proximal Humerus - Conservative vs Operative"

Quick Search

Relevant Topics

Osteoporosis
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Joint Disorders
A joint is where two or more bones come together, like the knee, hip, elbow, or shoulder. Joints can be damaged by many types of injuries or diseases, including Arthritis - inflammation of a joint causes pain, stiffness, and swelling with ...


Searches Linking to this Trial