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Radial Head Replacement Using Evolve Proline Modular Radial Head System (Wright Medical)

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Radial head fractures are common (approximately 20% of acute elbow injuries) and occur as a result of a fall onto an outstretched hand with the elbow in extension and wrist in pronation. The force is transmitted as an axial load through the wrist and through the radial head. They are more common in females and peak in the 4th decade.
The classification of radial head fractures is based a description of radial head fractures by Mason, but later modified by Broberg & Morrey and Hotchkiss . The classification is as follows and can be used in the decision making about which fractures may benefit from replacement of the radial head :
Type I – Undisplaced or minimally displaced (<2mm) or marginal lip fracture with no mechanical block
Type II – Displaced (>2mm) or angulated fracture, with mechanical block, without severe comminution
Type III – Comminuted and displaced fracture, not amenable to fixation
Type IV – Radial head fracture with associated dislocation
It must be appreciated by those treating these fractures that Radial head trauma can range from a simple, isolated fracture to complex fracture patterns with significant associated soft tissue components such as :
Lateral collateral ligament (LCL) injury. The most common association from axial loading in supination
Medial collateral ligament (MCL) injury .Occurring due to axial & valgus force
Combination LCL & MCL injuries. These are a higher energy and sit at the severe end of spectrum
Coronoid fractures. Occurring due to axial load in extension +/- dislocation
Fracture dislocation. These may result in “terrible triad” injuries of elbow dislocation, radial head fracture and coronoid fracture.
Essex-Lopresti injury. An associated distal radioulnar joint injury with rupture of the interosseous membrane
Radial head replacement is reserved for fractures that are significantly displaced, cause a mechanical block to motion or are not reconstructible. Other indications are discussed in the indications section following .There are various prostheses manufactured to replace the radial head.
The Evolve Proline Modular Radial Head System (Wright Medical Group) has several design features of note that recommend it. Firstly the prosthesis is modular so allows for variations in normal anatomy. The aim is restore the particular radial height and stability of the elbow joint in motion which requires this flexibility. Secondly the prosthesis utilises a spacer concept with a smooth stem that fits loosely into the radial neck. This allows motion at this level so that the prosthesis can conform with the articular surface throughout the range of movement.

INDICATIONS
Radial head replacement is used in the armamentarium for radial head fracture management. They are reserved for:
Comminuted Mason type III fractures that are unreconstructible
Mason type IV fractures where residual instability cannot be completely resolved by addressing other associated injuries
Essex-Lopresti injuries (as previously described)
Therefore, when dealing with these fractures, it is important to be aware of and consider possible injuries to associated strutures.
SYMPTOMS & EXAMINATION
Radial head fractures present with pain on the lateral aspect of the elbow. There may be associated swelling and limitation in flexion/extension as well as pronation/supination.
It is important to ascertain whether there is a true mechanical block in pronation/supination. Once the initial pain has settled, patients may notice a click.
Patients complain of tenderness on the lateral aspect of the elbow. If there is subluxation/dislocation of the radial head fragment, it can to be palpated posterolaterally. Passive pronation/supination of the wrist can help localise the radiocapitellar articulation.
In an acute presentation, it may be difficult to examine the elbow further due to pain. An aspiration of the haemarthrosis and injection of local anaesthetic to the joint can relieve pain to allow assessment for a mechanical block and stability.
When suspecting an Essex-Lopresti injury, assessment of the distal radioulnar joint (DRUJ) is required to confirm the diagnosis. Distal radioulnar ballotment test is performed with the elbow flexed to 90 degrees and resting on the table. It is assessed with the wrist in pronation and supination, whereby a translational force is applied across the DRUJ to assess the stability. A test is positive when pain is elicited or there is increased translation in comparison to the contralateral side. The interosseous membrane can palpated to elicit tenderness.
IMAGING
Plain AP and lateral radiographs of the elbow joint are required to confirm the fracture and the level of displacement. If an occult fracture is suspected, anterior and posterior fat pad signs can aid in diagnosis. A radiograph of the wrist is indicated if suspecting an Essex-Lopresti injury.
With comminuted radial head fractures, a CT of the elbow is helpful in surgical planning as well as delineating associated injuries.
NON-OPERATIVE TREATMENT
In Mason Type I fractures, isolated, undisplaced fractures are treated conservatively with temporary sling immobilisation and when comfortable, active ROM exercises are commenced under the guidance of physiotherapy services.
ALTERNATIVE SURGICAL MANAGEMENT
Partial Excision
For isolated Mason type II and type III fractures, if the fragments are not amenable to fixation, it is an option to excise these fragments. Figures quoted range from 25-33% of the articular surface can be excised. However, it is important to exclude associated injuries in this case and to ensure that the elbow is stable when assessed through a full range of movement.
Open Reduction and Internal Fixation (ORIF)
For Mason type II and type III fractures that are amenable to fixation, the radial head fragments can be fixed using cannulated headless screws, as well as radial plates.
Good to excellent outcomes have been reported but risks include metal work failure, malunion with complications increasing in more complex injuries.
Radial head excision
For Mason type III fractures that are not amenable to fixation, excision of the radial head can be performed.
Although reported putcomes in the literature have been good, it does alter elbow biomechanics. As a result, this procedure is largely reserved for patients of low demand or for failed conservative management.
It can result in ulnohumeral arthritis, valgus instabilty, proximal stump instability and tardy ulna nerve dysfunction.
It is contraindicated in Essex-Lopresti injuries and in elbow injuries with associated injuries due to the risk of residual instability.
CONTRAINDICATIONS
Open fractures are a relative contraindication due to the risk of infection.

The patient is consented according to the severity of the fracture. The patient would be consented for a variety of possible procedures including examination under anaesthesia +/- open reduction and internal fixation +/- partial excision +/- radial head replacement +/- ligament repair depending on the fracture pattern and likely method of definitive management.
Risks include DVT, PE, bleeding, infection, neurovascular injury (posterior interosseous nerve (PIN)), stiffness, residual pain, arthritis, heterotopic ossifcation and further procedure.
The patient is set-up in a supine position with the arm on an arm table. The patient’s upper body is sited as close to the lateral edge of the table as possible to allow adequate access for fluoroscopic images to be taken.
The upper limb is prepped from the hand to the shoulder and draped up to the shoulder.
Antibiotics are given according to Trust protocol.
A high arm tourniquet is applied and inflated after elevation of the limb.

The AP and lateral radiographs show a comminuted, displaced radial head fracture.
The main radial head fragment is displaced and dislocated posterior to the capitellum.

The patient is supine with the arm on an arm table. It is important to ensure that the body is positioned close to the edge of the table. This allows adequate intra-operative fluoroscopy images.
A gown pack can also be placed under the elbow to aid intra-operative visualisation.


A Kocher’s approach is used which utilises the intermuscular plane between anconeus (radial nerve) and extensor carpi ulnaris (posterior interosseous nerve, PIN).
The relevant landmarks include:
lateral epicondyle (A)
olecranon (B)
and radial head (localised on pronation/supination of forearm)
With the elbow flexed, the incision is sited 2-3cm proximal to the lateral epicondyle and extends distally to the posterior border of the ulna 10cm distal to the tip of the olecranon.
The distal extent of the incision is important to help define the anatomy and particularly the intermuscular plane.
The fascia is incised in line with the incision.
The forearm is maintained in pronation to move the PIN away from the surgical approach.

The incision is made through the skin and subcutaneous layer down to the fascial layer.
The subcutaneous fat is swept off the fascia to minimise the risk of injury to the lateral cutaneous nerve of forearm. This allows adequate exposure of the anatomy and identification of the muscle planes for the approach.
If greater exposure is required, the incision can be extended proximally along the lateral intermuscular septum.
The lateral cutaneous nerve of forearm is a branch of the musculocutaneous nerve. It runs a variable course but passes behind cephalic vein and divides into a volar and dorsal branch.
The volar branch descends along the radial border of the forearm to the wrist and supplies sensation to the lateral half of the volar forearm skin.
The dorsal branch descends along the dorsal surface of the radial forearm to the wrist. It supplies sensation to the lower two thirds of the dorsolateral forearm skin.

Before proceeding further one should orientate oneself with the deeper anatomy.
A – lateral epicondyle
B – anconeus
C – extensor carpi ulnaris

The fascia is incised between extensor carpi ulnaris (A) and anconeus (B).
Note that plane between the 2 muscle bellies is ill defined.
It is best identified by looking at the orientation of the muscle fibres and also by a dip in the convexity of the muscle fascia due the tethering of the deep fascia between the two compartments.
Distally, the proximal fibres of supinator are split. Note the forearm remains in pronation and approach is on the dorsal aspect of the radial neck to minimise risk of injury to the PIN.
The PIN is a continuation of the radial nerve after it divides from the superficial sensory branch in the arm. Proximally, the PIN is separated from the joint by the brachialis muscle. Distally, it passes under the arcade of Frohse at the proximal edge of supinator before continuing on the dorsal surface of the interosseous membrane.

Deep to the fascia, the capsule is incised and the haemarthrosis is evacuated. The capular incision is extended distally.
Care is taken to protect the humeral attachment of the lateral collateral ligament (LCL). This is ensured by staying anterior to the centre of rotation of the capitellum (A).
Note that the LCL can be ruptured from the mechanism of injury. It this is the case, it needs to be repaired.
The LCL originates from the lateral epicondyle of the humerus and attaches to the supinator crest of the ulna.
The annular ligament is identified distally and incised to expose the radial neck. It is separated from the capsular layer and tagged so that it can be repaired separately on closure.
The annular ligament is usually incised in line with the approach towards the dorsal aspect of the radial neck to minimise risk of injury to the PIN. Care is taken to ensure that the annular ligament is not incised by its ulnar attachment posteriorly as it may compromise repair if there is very little tissue to reattach at the end of the procedure.

The radial head can now be clearly identified and assessed
It is rotated and dislocated posteriorly in relation to the capitellum.

The posteriorly dislocated radial head fragment is defined.
The image shows that it is devoid of soft tissue attachment.
The fracture is assessed in relation to remaining fragments and whether it is repairable.
In this case, it was excised and preparation made to proceed to a radial head replacement.

Once the radial head is excised, an assessment of the coronoid can be made (seen at the tip of forceps).
The coronoid acts as an anterior butress to prevent posterior subluxation.
Regan and Morrey classified coronoid fractures into:
Type 1 – Coronoid tip fracture
Type 2 – Fracture involving up to 50% of height
Type 3 – Fractures greater than 50% of height
In general, minimally displaced fractures can be treated conservatively if the elbow is stable.
If the there is concern regarding stability, it may require fixation to enhance stability.
Note: If it is felt that the coronoid fragment may require fixation, a Kaplan approach may give a better exposure to the coronoid. This utilises the intermuscular plane between extensor carpi radialis brevis (ECRB) and extensor digitorum communis (EDC). These are supplied by the radial nerve. Care must be taken as the PIN is at greater risk.

Once the fragments are cleared, a conservative perpendicular cut is made on the residual radial neck.
Care is taken when retracting the soft tissues radially to protect the Posterior Interosseous Nerve (PIN)

Once all the fragments are excised and retrieved, it is useful reconstruct the radial head to:
1. appropriately size up the prosthesis
2. ensure that all the fragments have been retrieved from the joint

The prosthesis is sized using the template .
It is sized off the inner diameter of the radial head’s articulating surface rather than the outer diameter the head that articulates with the proximal radioulnar joint.
For elliptically shaped head, the minimum diameter is selected. If in between sizes, it is preferable to downsize.
If a previous radial head excision has been performed, a radiograph of the contralateral normal radial head is used as a guide for sizing.

The radial neck canal is opened using the starter awl.
It is sequentially reamed by hand using the stem broaches by hand down to the depth indicator on the broaches.
Adequate reaming is achieved once there is cortical bone contact in the intramedullary canal.

If required, the last stem broach can be left in situ and a neck planer can be applied over the broach and rotated clockwise to ensure that the neck cut is perpendicular to the axis of the of the radial neck
This allows the prosthesis to sit square on the neck.
Excessive planing is avoided to ensure that an appropriate length prosthesis can be implanted.
Note, when retracting, it is important to avoid levering over the course of PIN to prevent iatrogenic injury.

When selecting the appropriate trial components, the prosthesis should fit easily into the canal.
It is designed to sit slightly loose but not sloppy in the canal to allow the implant to toggle and conform with the capitellum during range of motion. The trial selected is usually a size down from the last reamer used.
The prosthesis is modular and is made up of a head and stem component.
Both components are available in a standard size with a +2mm and +4mm option.
This allow a possible build-up of +8mm in total and allows flexibility in matching the patient’s anatomy.
Ideally, the head component is matched to the patient’s native radial head to ensure a congruent articulation with the proximal radioulnar joint.
The stem component is to allow restoration of the radial length which ensures a congruent and stable radiocapitellar articulation.
Note that in the image, there is an increase in radiocapitellar space present due to the release of the annular ligament during the approach. It is useful to have tagging sutures to the incised annular ligament to aid reduction and stability of the radiocapitellar joint when assessing prosthesis size and length.

The elbow is screened under fluoroscopy to ensure that the radial head replacement is appropriate in size for radiocapitellar articulation and proximal radioulnar articulation and height.
This is best shown on AP with the elbow in extension with the forearm in supination.
Radial height is assessed by restoring the articulation in line or even just proximal to the level of the coronoid (to account for the cartilage layer).
When assessing radial height, it is important to avoid overstuffing the radiocapitellar articulation. This is assessed by radial opening of the ulnohumeral articulation.
If critical, there does appear to be some opening of the ulnohumeral articulation on the trial images.

In most injuries, the proximal radius is mobile enough that the implant can be assembled on the back table and inserted as a monoblock implant.
The head and stem components are selected. This image shows the selected head placed on the sizing and assembly dish.

The selected stem is placed onto the head component.

The stem impactor is placed over the stem and impacted using a mallet.

The proximal radius can be retracted laterally to allow a straight run down the axis of the radial neck.
The implant is inserted manually.
There is usually enough clearance for the prosthesis to pass the capitellum on insertion.

Once the implant is seated, it is assessed for congruency on range of movement and stability.
The annular ligament (anterior leaflet held in forceps) has already been separated from the capsular layer.
If there are concerns regarding stability or tracking, the tagging sutures to the annular ligament leaflets can be temporarily tied or secured with an artery clip to restore the integrity of the annular ligament.
This stabilises the radial head and allows more normal tracking of the radiocapitellar joint.

The prosthesis is also screened under image intensifier.
It is important to note that the prosthesis is fully seated and that the joint line has been restored to or just proximal to the level of the coronoid.

Once satisfied, closure can be commenced.
It is worth noting at this stage that if the LCL is ruptured, it will need to be repaired (see described technique).
It is usually ruptured from the humeral attachment at the lateral epicondyle (origin) and the free end can usually be seen on the undersurface of the muscle fascia.
It can also be palpated as a thickening of the muscle fascia and is usually more robust. The LCL acts as a sling for the radial head and if the injury is missed, can lead to posterolateral instability.
The LCL complex is composed of:
lateral ulnar collateral ligament – attaches to supinator crest on ulna
radial collateral ligament – blends with annular ligament deep to common extensor tendon
annular ligament – from posterior to anterior margin of radial notch on the ulna and encircles the radial head
accessory lateral collateral ligament – inferior border of annular ligament to supinator crest

The annular ligament is repaired using 1-0 vicryl interrupted sutures.
Care it taken not to overtighten the repair to minimise any restriction in pronation and supination.

The fascial layer is repaired using 1-0 vicryl in a continuous running stitch.

The fat layer is repaired using 2-0 vicryl to minimise the dead space.
The skin layer is closed using a 3-0 monocryl subcuticular stitch.

Dressings are completed using steristrips/opsite/wool/crepe.

As with all elbow injuries, once surgical stabilisation has been achieved, the aim is for early mobilisation to minimise the risk of stiffness.
Patients are immobilised initially in wool and crepe bandages and a sling.
They are given wrist, finger and shoulder exercises under the guidance of a physiotherapist.
Early active assisted elbow mobilisation is commenced in flexion/extension and pronation/supination once pain allows. This is usually in the first 2-3 days.
Active and passive stretching and strengthening is commenced at 6-8 weeks.
For elbow injuries with associated injuries, a hinged elbow brace is applied, limiting range of movement from 45 – 90 degrees for the first 3 weeks, and increasing the range as clinically appropriate.


Harrington IJ, Sekyi-Otu A, Barrington TW, Evans DC, Tuli V. The functional outcome with metallic radial head implants in the treatment of unstable elbow fractures: a long-term review. J Trauma. 2001 Jan;50(1):46-52.
A long term study (mean follow-up – 12.1 years, 6 – 29) of 20 patients with unreconstructible radial head fracture and elbow instability. Results suggest that the radial head replacement functions well on a long term basis.
Laflamme M, Grenier-Gauthier PP, Leclerc A, Antoniades S, Bédard AM. Retrospective cohort study on radial head replacements comparing results between smooth and porous stem designs. J Shoulder Elbow Surg. 2017 Aug;26(8):1316-1324. doi: 10.1016/j.jse.2017.04.008. Epub 2017 Jun 9.
A study comparing outcomes of the Evolve radial head replacement with porous stem prostheses. A cohort of 46 patient were included in the study. Results suggest a higher rate of osteolysis in the porous stem group, although there was no difference in DASH score. Mean follow up of Evolve group (17 patients) was over 10 years. Both groups had excellent functional outcomes.


Reference

  • orthoracle.com
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