AcromioTape System TM

Transcription

1 AcromioTape System TM Stabilization of the dislocated Acromioclavicular joint with associated disruption of the Coracoclavicular ligaments Surgical Technique Manual 0086

2 Introduction AcromioTape System TM Disruption of the pectoral girdle - that is complete rupture of the coracoclavicular ligaments and the acromioclavicular joint - is increasingly common largely due to the explosive increase in mountain biking as a recreational activity. Late diagnosis of such injuries is almost universal and management still controversial. The use of the implant in the manner described in this technique manual rapidly restores shoulder function in injuries that are otherwise difficult to manage successfully. The AcromioTape System comprises a wide, open weave, 20 mm x 500 mm Poly-Tape implant and associated instruments to provide a non-tissue harvesting repair. The open weave structure of the tape acts as a scaffold allowing tissue ingrowth. This ingrowth protects the tape from abrasion and as it matures provides additional strength. Additionally: the Poly-Tape implant carries none of the risks or availability problems of allograft; there is no donor site morbidity as encountered with autografts; the large width of the Poly-Tape prevents it cutting through the coracoid process; the Poly-Tape can be passed through small holes which reduces the chance of bone fracture. We would like to thank Mr N. Kay TD FRCS, formerly Consultant Orthopaedic Surgeon, Royal Hallamshire Hospital, UK, for his work in developing this technique.

3 IMPLANT The AcromioTape System uses a 20 mm x 500 mm Poly-Tape. It is manufactured from polyester, a biocompatible material that has been in use for the reconstruction of ligaments and tendons for over 25 years. It has several structural features intended to facilitate the surgery and improve its outcome, as shown in the image (right). It can be passed through small holes which reduces the chance of bone fracture INSTRUMENTATION The following instruments are packed with the implant set: 20 cm malleable probe with eye for passing the Poly-Tape through soft tissue; a 2.5 mm diameter drill bit (plain shank); a 3.2 mm diameter drill bit (plain shank). The continuous longitudinal yarns of the device provide it with sufficient strength to allow early mobilization INDICATION The Poly-Tape is indicated for treatment of a disrupted acromioclavicular joint. Contraindications, warnings and precautions: please refer to the general Contraindications, Warnings and Precautions listed in the Poly-Tape Instructions for Use leaflet (Ref. LAB 028) packed with the implant; the Poly-Tape could possibly break through the bone if tunnels are incorrectly positioned, the bone is of poor quality, or prescribed activity levels are exceeded. It has an open weave mesh, designed to act as a scaffold for soft tissue ingrowth and neoligament formation The large width spreads the load on the coracoid and prevents the Poly-Tape cutting through the bone

4 Functional Anatomy The role of the clavicle in stabilizing the shoulder is increasingly recognized 1. The movements of the clavicle relative to the coracoid are controlled by the twin parts of the coracoclavicular ligaments, stabilizing the clavicle and controlling its rotation and elevation during movements of the shoulder. In this respect, the coracoclavicular ligaments can be compared to the cruciate ligaments in the knee. Since rotation of the clavicle is an essential part of its arc of movement, this effectively negates the use of wires, screws and other such static devices when attempting to stabilize the clavicle to the coracoid after disruption of the coracoclavicular ligaments. Attempts to utilize other ligaments 2, 3 have been described but are technically difficult and inevitably lead to morbidity at the donor site. Complete rupture of the coracoclavicular ligaments with dislocation of the acromioclavicular joints is usually classified as a stage II, III or IV acromioclavicular injury depending upon the location of the clavicle. However, in the author s view this seriously understates the nature of the injury, for the pectoral girdle loses its stability and the powered function of the shoulder is permanently diminished by some 25%. In young, active patients this imposes serious lifestyle limitations, not only in sports and recreation but also in employment, effectively precluding such tasks as steel erecting, scaffolding, fire fighting, etc.

5 Clincal Presentation The patient usually presents in the Accident and Emergency Department with a history of a fall onto the postero/superior aspect of the shoulder (i.e. the area above the spine of the scapula, as distinct from the point of the shoulder), often having fallen off a mountain bike or horse. The entire pectoral area is swollen, all movements of the shoulder painful and restricted but at this stage, the x-rays are normal, since the massive internal haemorrhage effectively stabilizes the acromioclavicular joint and clavicle. Over the next 2-3 weeks, as the haematoma is reabsorbed, movements of the shoulder gradually return and at about 6 weeks a reasonable range of shoulder movements will be permitted. At this time, weight-bearing x-rays (10-15 kg held in each hand) will demonstrate the true nature of the injury. Note: it is always advisable to use a thyroid screen when taking these x-rays. Weight bearing x-ray of uninjured side Injured side

6 Surgical Technique 1 2 PREPARATION AND INSPECTION The procedure is performed in the beach chair position. Pre-operative antibiotics should be given. The limb is prepared and draped using aseptic technique. RECOMMENDED APPROACH Exposure of the lateral third of the clavicle and the lateral edge of the acromion and the coracoid process can be achieved by a sabre type of serpiginous skin incision. The coracoid process is identified with the finger and revealed by a deltoid splitting approach, and the attachment of the intact coracoid-acromial ligament is usually seen at the tip of the coracoid process. A malleable probe, or curved cholecystectomy forcep, is used to pull a 20 mm x 500 mm Poly-Tape behind the root of the coracoid process. The lateral third of the clavicle, the acromioclavicular joint and lateral edge of the acromion are then defined, cleared of haematoma and fibrous tissue. A blunt nosed periosteal elevator (Robert Jones) is pushed under the lateral third of the clavicle to expose the acromial end of the clavicle.

7 3 4 5 A 2.5 mm drill is used to create a pilot hole up the medulla of the clavicle. This hole is then widened as far as judged necessary with larger drills to a maximum diameter of 3.2 mm. NOTE: When drilling bone tunnels always take care to leave an adequate bone thickness between the tunnel and the surface to provide sufficient bone to resist expected forces that will be exerted on the bone by the reconstruction. Take into account the quality of the bone. NOTE: Where possible, round the tunnel edges to prevent abrasion of the Poly-Tape. A similar hole (3.2mm) is drilled in the superior surface of the clavicle at the site where the coracoclavicular ligaments were attached to the underside prior to rupture. This should meet the previous hole in the medulla of the clavicle BUT not break through into the inferior cortex. A similar technique is used to prepare a hole in the acromion. This is technically more difficult, due to the flat nature of the acromion. Ideally the pilot hole should emerge close to the lateral edge of the acromion. This completes the necessary tunnels for passage of the Poly-Tape.

8 6 7 8 The twin strands of the Poly-Tape are passed upwards, deep to the deltoid (which is usually stripped from its clavicular attachment over its lateral third due to the trauma) to emerge below the clavicle. A half reef knot is then tied below the clavicle. The two strands of the Poly-Tape are brought around the clavicle and a loose reef knot tied just above the clavicle. The probe is used to pass one (long) end of the Poly-Tape through the clavicle, across the acromioclavicular joint and through the acromion.

9 An assistant then presses down on the clavicle to restore acromioclavicular alignments. The half reef knot below the clavicle is then adjusted to its proper tension, the reef knot above the clavicle is adjusted to its proper tension and the whole system is then tightened. A further knot is tied, utilizing the two strands of the Poly- Tape, one of which will have passed through the clavicle, across the acromioclavicular joint and the acromion, and the other simply issuing from the reef knot above the clavicle. These two strands are then tied once more in a reef knot to stabilize the entire system. The range of motion is assessed. If this is satisfactory each surplus end of the Poly-Tape is cut with scissors at right angles to its length. This will minimize the generation of loose fibres. It is wise to leave a 3 or 4 cm end of the Poly-Tape after tying the second knot and cutting off the redundant parts, and these ends are carefully sutured down to the surrounding soft tissue to prevent the knot unravelling. IMPORTANT: Any loose fibres created when trimming the Poly-Tape to length must be carefully removed from the incision site. WOUND CLOSURE The entire clavicle and acromion and supporting ligaments are then buried as far as possible in the surrounding soft tissues, which are carefully reconstructed. Closure in two layers, sub-cutaneous tissue and skin, over a suction drain completes the surgery.

10 POST-OPERATIVE MANAGEMENT Immediate post-operative actions A broad arm sling is used. Rehabilitation programme A broad arm sling for five to seven days post-operatively aids comfort, after which gradual mobilization is encouraged. Physiotherapy is not usually necessary and full movement is gradually regained at six weeks. A gradual build up of strength over the next few months allows return to full activity. Contact sport, however, should be avoided for six months. REFERENCES 1. Ljunggren AE. Clavicular Function. Acta Orthop Scand. 1979;50: Weaver JK, Dunn HK. Treatment of Acromioclavicular Joint Injuries, Especially Complete Acromioclavicular Separation. J Bone Joint Surg [Am]. 1972;54-A: Dumontier C, Sauteta A, Man M, Apoil A. Acromioclavicular Dislocation, Treatment by Coracoacromial Ligamentoplasty. Journal Shoulder Elbow Surgery. 1995;4: Patients with an active lifestyle may, however, wish to follow a detailed Rehabilitation Programme as described in the document entitled AcromioTape System Rehabilitation Programme for Stabilization of the Acromioclavicular Joint (LAB 128). This Rehabilitation Programme was developed in conjunction with Ian Horsley MSc, MCSP, Clinical Lead Physiotherapist, English Institute of Sport (EIS) North West, of BackinAction Physiotherapy and Sports Injury Clinic, Wakefield, UK. The patient should be warned not to exceed the prescribed activity levels or to overload the repair before complete healing has occurred. All mobilization and exercises should be performed within the pain free range of movement.

11 Ordering Information AcromioTape System Implant Set ( ) includes: 20 mm x 500 mm Poly-Tape (supplied sterile) Packaged with the following disposables: Probe with eye - nickel silver 20 cm (supplied sterile) Drill bit, plain shank to fit Jacobs Chuck, 2.5 mm diameter (supplied sterile) Drill bit, plain shank to fit Jacobs Chuck, 3.2 mm diameter (supplied sterile) Individual re-order Codes: mm x 500 mm Poly-Tape (supplied sterile) Probe with eye - nickel silver 20 cm (supplied sterile) Drill bit, plain shank to fit Jacobs Chuck, 2.5 mm diameter (supplied sterile) Drill bit, plain shank to fit Jacobs Chuck, 3.2 mm diameter (supplied sterile) Please refer to the Instructions for Use leaflet packed with the Poly-Tape for essential information including Use, Sterility, Indications, Contraindications, Warnings and Precautions, Potential Adverse Effects and Storage. Additional copies may be obtained from Neoligaments sales department, or downloaded from

12 Developed and manufactured by Neoligaments A division of Xiros Springfield House Whitehouse Lane Leeds LS19 7UE Tel. +44 (0) Fax. +44 (0) [email protected] Registered in England No All rights reserved. Neoligaments Worldwide patents and patents pending. Neoligaments, AcromioTape System and Xiros are trademarks of Xiros. LAB