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Proximal femoral endoprosthesis- Stanmore METS implant (Stryker) with trochanteric reattachment for pathological fracture

Professional Guidelines Included
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Endoprosthetic replacements of the proximal femur are one of the most common limb-salvage procedures undertaken to reconstruct massive bone defects secondary to tumour, trauma or infection.
The increasing burden of metastatic bone disease means more cases present to orthopaedic surgeons. Breast cancer is the most common cancer in women and because of advances in systemic therapy, is now considered a chronic disease in many cases. Two thirds of breast cancer patients will develop skeletal metastases which cause skeletal related events (SREs: pathological or impending fracture, hypercalcaemia, spinal cord compression, severe pain) which may require surgery and/or radiotherapy to palliate pain and to preserve mobility and quality of life.
For patients with subtrochanteric bone tumour involvement, fracture and patients with a good prognosis may best be managed with endoprosthetic replacement. Resection of a tumour from the proximal femur requires reconstruction of the large bone and soft-tissue defect and the complications of such surgery from a systematic review include dislocation (5.8%), infection (5.2%), local recurrence (4.7%) and peri-prosthetic fracture (0.6%). These are both reliable and durable implants that offer immediate mobility and return to function; however in the long-term complications and failure mean that ten year implant survival is approximately 75%.

Author :Mr Jonathan Stevenson FRCS (Tr & Orth)
Institution :The Royal Orthopaedic Hospital Birmingham ,UK.
Clinicians should seek clarification on whether any implant demonstrated is licensed for use in their own country.
In the USA contact: fda.gov
In the UK contact: gov.uk
In the EU contact: ema.europa.e

INDICATIONS:
The indications for proximal femoral endoprosthetic replacement are to reconstruct massive bone defects following malignancy, infection, trauma or failed arthroplasty. In oncology, tumours may either be primary or metastatic (secondary) bone tumours, or soft tissue sarcomas which have invaded the bone. Within this group pathological fractures may develop, where by the bone is weakened to the point of failure by the presence of the tumour.
The incidence of deep prosthetic joint infection following total hip replacement is approximately 1%. The treatment for infected hip replacements may involve explanting the infected prosthesis and insertion of a new prosthesis. Recurrent infections may be difficult to treat particularly when dealing with bone loss from previous surgeries which may necessitate endoprosthetic reconstruction.
Failed internal fixation of proximal femoral bone loss, particularly in osteoporotic bone, may lead to sever bone loss: endoprostheses replace this lost bone expeditiously which may be essential in comorbid patients with osteoporosis.
SYMPTOMS & ASSESSMENT:
Biopsy tract, range of motion of hip and knee, limb length, deformity, neurovascular status, skin quality including previous scars and sinuses, abductor function, availability of local soft tissue flaps as required.
INVESTIGATION:
Measured radiographs of the whole femur, pelvic AP radiograph
MRI whole femur including hip joint
Staging dependent upon histological diagnosis (in this case CT chest-abdomen-pelvis to exclude visceral metastasis, whole-body bone scintigraphy to identify other skeletal metastases)
OPERATIVE ALTERNATIVES:
Primary malignant bone tumours: Allograft or allograft prosthetic composite
Subtrochanteric metastases in the presence of fracture and/or multiple osseous or visceral metastases with limited life expectancy: medullary nail or plate with cement augmentation
NON-OPERATIVE ALTERNATIVES:
Radiotherapy
Systemic therapy (which for breast cancer includes hormone therapy, chemotherapy, denosomab and bisphosphonates)
CONTRAINDICATIONS:
Active osteomyelitis
Poor soft tissue coverage (if plastics surgical flap not available)
Insufficient distal bone stock to accept medullary stem necessitating total femoral endoprosthesis
Paediatric patient too young and small to receive custom growing prosthesis

GA + spinal
Prophylactic antibiotics, ultra clean theatre
Lateral decubitus position with hip props, pillow between calves, exclusion drape
Double alcoholic skin prep, hip and thigh exposed, calf and foot excluded by drapes, ioban incise drapes
VTE prophylaxis: early mobilisation protected weight bearing with crutches, LMWH chemoprophylaxis dose at least 6 hours post-operatively for 4 weeks, thigh lengths TED stockings for 6 weeks and foot pumps or flowtrons (calf compression devices) until mobile

Position patient lateral decubitus and isolate the lower limb.
Lateral decubitus, pillow and exclusion drape evident, hip marked with permanent marker pen, hip props evident anteriorly

Alcoholic skin preparation.First skin prep with alcoholic chlorhexidine including the foot.

Initial drape position after first skin preparation

Drapes application.Second skin prep complete, foot and calf isolated, ioban incisional drapes evident, iliac crest and most of gluteus exposed

Lateral skin incision centred over the greater trochanter.Lateral skin incision (elliptical excision of biopsy tract as appropriate) centred over greater trochanter curved posteriorly following the fibres of gluteus maximus proximally and distally parallel to the iliotibial band and femur

Incise the fascia lata in line with the skin incision.Diathermy used to incise fat down to deep fascial layer and iliotibial band (fascia late) which is incised in line with skin incision.

Deep fascia and iliiotibial band retracted using (CB) Charnley bow, revealing the (GT) greater trochanter with gluteus medius inserting onto it and the (VL) vastus lateralis distally. Gluteus medius arises from the outer table of the ileum and gluteal aponeurosis and is supplied by the superior gluteal artery and nerve (L5/S1) (which also supplies gluteus minimus, tensor fascia lata and piriformis).

Release the tendon of gluteus maximus off the posterior femur.Gluteus maximus tendon identified posteriorly and released using diathermy off the posterior femur with care not to disrupt the first perforating branch of the profunda femoris artery & vein and damage the sciatic nerve. The three perforating arteries all ‘perforate’ adductor magnus have branches that anatomose cranially and caudally with each other. The other main branches of the profunda femoris are the medial and lateral circumflex femoral arteries which supply the proximal femur. The (GT) greater trochanter is also shown in the centre of the wound.

Release the external rotators off the posterior greater trochanter.Release of external rotators from posterior proximal femur and (GT) greater trochanter: External rotators from proximal to distal released off the femur (piriformis, gemellus superior, obturator internus, gemellus inferior, quadratus femoris and obturator externus). Care at this stage is required as the sciatic nerve (L4-S3) lies immediately posterior to the external rotators, so gently palpating for the nerve running longitudinally from the sciatic notch over the ischium and into the posterior compartment of the thigh by passing deep to the gluteus maximus tendon, so that you are aware of its location and can protect it. the sciatic nerve exits below the piriformis muscle; the other structures that exit the greater sciatic notch below piriformis include: Pudendal nerve, nerve to the Obturator Internus, Posterior femoral cutaneous nerve, Sciatic nerve, Inferior gluteal artery and nerve, nerve to Quadratus Femoris – remembered by the mnemonic POPS-IQ.
In this case for a pathological fracture in metastatic bone disease marginal margins are acceptable as the fracture has already seeded cancerous cells into the tissues and adjuvant radiotherapy and systemic therapies are available.

Elevate vastus lateralis (VL) off the lateral femurUsing cautery elevate vastus lateralis (VL) off the lateral femur in line with the (TSO) trochanteric slide osteotomy.

Elevate the vastii muscles off the femurBy displacing the (TSO) trochanteric slide osteotomy anteriorly with the (VL) vastus lateralis attached, the skeletonised (F) femur becomes visible. Using a periosteal elevator the anterior vastus medialis can be elevated off the femur.

Post-operative radiograph showing satisfactory reconstruction of the greater trochanter.

Elevate the vastus lateralis off the proximal femur.(T) Trethowan’s retractor inserted under vastus origin on the proximal femur, which gently elevates the soft-tissues from the bone for release with diathermy.

Trochanteric osteotomy.(BS) Bone saw used to osteotomise the trochanter from the piriformis fossa to the trethowan’s under vastus lateralis – thus preserving a sleeve of tissue connecting gluteus medius/trochanter/vastus lateralis.

Elevate the osteotomy maintaining the abductors and vastus lateralis in continuity.(O) osteotomes used to complete the osteotomy and elevate the (TSO) trochanteric slide osteotomy keeping (VL) vastus lateralis and gluteus medius attached in a sleeve of tissue.

Continue to skeletalise the proximal femur by releasing the psoas tendon.Diathermy used to release the soft tissues proximally, distally and anteriorly to lift the trochanteric slide osteotomy off the shaft of the proximal femur which is externally rotated by the assistant. The dissection is continued superiorly and anteriorly to release gluteus minimus off the proximal femur and as access improves and the femur lifts out of the wound the (PT) psoas tendon can be released off the lesser trochanter.

Heygroves bone holding forceps grasp femur distally to help control the distal femur prior to the osteotomy and also it helps with soft-tissue retraction.

Measure the level of femoral osteotomy.(R) Ruler used to measure the level of bone resection from trochanter determined by pre-operative planning on MRI scan. Tip: Kocher forceps grasps the ruler at the desired measurement level.

Osteotomise the femur using oscillating saw.(DFO) Distal femoral osteotomy completed at the measured resection level perpendicular to the bone using oscillating power saw, heygroves positioned distal to the osteotomy. The proximal femur is now excised by dividing pectineus, adductor brevis and the pubofemoral portion of adductor magnus inserting medially off the femur under gentle tension.
Adductor magnus has two portions: the pubofemoral portion arises from the pubis and inserts onto the medial proximal femur and is supplied by the obturator nerve. The Ischiocondylar portion arises from the ischium and inserts onto the adductor tubercle of the distal femur and is supplied by the sciatic nerve.

Sample the medullary canal tissue for histology at the resection level.The distal resection margin medullary bone is sampled using a small spoon and sent for histological analysis (more important in primary bone tumours) to ensure that the resection is clear of the tumour.

Capsulotomy to enter the joint.A long blade is used to incise the capsule held between two Kocher’s forceps to perform a (C) capsulotomy (for repair later).

Remove the femoral head.A corkscrew (or two schanz pins)is inserted in the (FH) femoral head, which is sent for histological analysis in view of the metastatic bone disease.

Ream the distal femur using power reamers.Reaming of distal femur to permit insertion of a medullary stem (in this case 150mm in length). A flexible medullary reamer (R) is used taking care not to catch any soft tissues. This enables a greater diameter femoral stem to be used which has grater resistance to bending forces (like in a femoral nail).

Measure the excised femoral head.Femoral head is measured using callipers to determine the size of the unipolar hemiarthroplasty head to be inserted on the proximal femoral endoprosthetic neck.

The resected proximal femur showing the (PF) pathological fracture of the femoral neck (closest to ruler), the (TSO) trochanteric slide osteotomy (furthest from ruler) and the (DFO) distal femoral osteotomy.

Assemble a trial modular endoprosthesis.(M) modular proximal femoral endoprosthesis trial with 150mm stem and hemiarthroplasty head in comparison to resected (PF) proximal femur aiming not to lengthen more to shorten the affected femur by approximately 0.5-1cm to facilitate walking with hip abductor dysfunction. The femoral head has been placed at the pathological fracture site for completeness.

Insert the trial endoprosthesis and reduce the hemiarthroplasty femoral head.(T) Trial modular prosthesis inserted with 20 degrees of anteversion applied to stem and checked for stability, range of motion and limb length as for any trauma hemiarthroplasty. It is worth marking with cautery on the residual femur the desired anteversion so that this can replicated when cementing the definitive prosthesis. (TSO) trochanteric slide osteotomy shown.

Assemble the definitive modular endoprosthesis components.Backtable assembly of modular prosthesis: Unipolar femoral head, right sided trochanter with hydroxyapatite reattachment surface, stem with integral hydroxyapatite collar are shown.

(D) Derotation lug on the shaft inserts into female recess on the inside of the trochanter component.

The taper is impacted to connect the trochanteric and integral stem components using the mallet supplied with the set.

The unipolar head is impacted onto the morse taper or the femoral neck.

(HA) Trochanter laterally has a roughened shoulder with hydroxyapatite surface to reattach the trochanteric slide osteotomy. Hydroxyapatite coated (C) collars permit bone ongrowth to prevent aseptic loosening of the stem according to Coathup et al. (Coathup MJ, Batta V, Pollock RC, Aston WJ, Cannon SR, Skinner JA, Briggs TW, Unwin PS, Blunn GW. Long-term survival of cemented distal femoral endoprostheses with a hydroxyapatite-coated collar: a histological study and a radiographic follow-up. J Bone Joint Surg Am. 2013 Sep 4;95(17):1569-75. doi: 10.2106/JBJS.L.00362).
Final assembly showing the surgeons view prior to implantation with trochanteric reattachment surface evident. Note the bowed femoral stem should match the anterior bow of the native femur (and if it doesn’t then the wrong sided trochanteric prosthesis has been opened).

Distal femoral medullary canal preparation prior to cementation. Tip: Check your cement nozzle fits inside the medullary cavity before mixing. Routine canal preparation with lavage and drying with ribbon gauze prior to cementation is required, without a cement restrictor as the stem lies distal to the isthmus. Pre-warn the anaesthetist about impending cementation due to the risk of Bone Cement Implantation Syndrome which is associated with hypoxia, hypotension, loss of consciousness and cardiovascular collapse according to Donaldson et al. (A. J. Donaldson, H. E. Thomson, N. J. Harper, N. W. Kenny, Bone cement implantation syndrome, BJA: British Journal of Anaesthesia, Volume 102, Issue 1, January 2009, Pages 12–22, https://doi.org/10.1093/bja/aen328).

Fill the canal with cement.Retrograde insertion of palacos-G cement.

Cement filled femur immediately prior to insertion of definitive endoprosthesis. Heygroves holding distal femur.

Insert the definitive endoprosthesis stem into the cement filled distal femur.In a smooth motion the implant is inserted with correct anteversion into the canal and (E) excess cement is removed (as cement covering the hydroxyapatite collar may prevent osseointegration) using McDonald elevator.


(D) Definitive endoprosthesis immediately prior to reduction of the hemiarthroplasty head into the native acetabulum.

Reduce the definitive hemiarthroplasty head into the native acetabulum.(K) two kosher’s forceps holding the capsule open to prevent a leaf of the capsule being trapped inside the acetabulum by the hemiarthroplasty head.
The head of the definitive endoprosthesis is reduced into acetabulum. (TSO) trochanteric slide osteotomy with gluteus medius and (VL) vastus lateralis attached proximally and distally, are retracted.

Close the capsulotomy.(S) Suture closure of the capsulotomy leaves with 1.0 vicryl to help prevent dislocation. Henderson et al. reported that purse string capsular repair reduces the risk of dislocation in 2010 (Henderson ER, Jennings JM, Marulanda GA, Palumbo BT, Cheong D, Letson GD. Purse-string capsule repair to reduce proximal femoral arthroplasty dislocation for tumor–a novel technique with results. J Arthroplasty. 2010 Jun;25(4):654-7. doi: 10.1016/j.arth.2009.11.002.), but then concluded the opposite in 2017 (Henderson ER, Keeney BJ, Pala E, Funovics PT, Eward WC, Groundland JS, Ehrlichman LK, Puchner SS, Brigman BE, Ready JE, Temple HT, Ruggieri P, Windhager R, Letson GD, Hornicek FJ. The stability of the hip after the use of a proximal femoral endoprosthesis for oncological indications: analysis of variables relating to the patient and the surgical technique. Bone Joint J. 2017 Apr;99-B(4):531-537. doi: 10.1302/0301-620X.99B4.BJJ-2016-0960.R1.). We feel that using the capsular repair (capsulorraphy) to improve stability is indicated whenever sufficient capsular tissue remains after tumour excision.

Approximate the osteotomised trochanter to the reattachment surface of the prosthesis trochanter.The forceps approximating the (TSO) trochanteric slide osteotomy to the hydroxyapatite coated reattachment surface of the implant. Here the sleeve of tissue comprising the (GM) gluteus medius, trochanteric slide osteotomy and (VL) vastus lateralis will help to restore abductor function, aid wound closure to prevent infection and hopefully minimise the risk of dislocation post-operatively.

Loop super cables through the prosthesis holes.Two iso-elastic (P) polymer cables (Supercable, Kinamed) inserted through the holes located in the prosthesis to enable (TSO) trochanteric slide osteotomy reattachment.

Tension and lock the super cables to reattach the trochanteric osteotomy.Cables fed through the gluteus medius anteriorly and over the trochanter and tensioned. The cables are locked by the (T) tensioner by deploying a locking wedge into the clip as shown.

The cable grips positioned posteriorly to avoid irritation of the iliotibial band, blade used to cut residual cable.

Reattach the tendon of gluteus maximus to the posterior vastus lateralis.(GM) Fibres of gluteus medius inserting onto trochanteric slide osteotomy, which has the polymer cables attaching it to the prosthesis. Vastus lateralis is shown covering prosthesis (reducing deadspace and helping to prevent infection). (GMax) Tendon of gluteus maximus reattached using vicryl suture, to the posterior aspect of (VL) vastus lateralis taking care not to damage sciatic nerve.

Reattach the external rotators.(S) Suture the external rotators onto the back of the trochanter to cover the metal clips of the cables, using 2.0 vircyl.

Layered closure of fascia lata.Looped PDS suture to close the iliotibial band and fascia lata.

Pulsed lavage of superficial layer of tissue prior to closure.

Layered skin closure.Closure with interrupted vicryl to deep dermis.

O vicryl running suture to dermis.

Apply dressings.Aquacel dressing.

VTE prophylaxis: early mobilisation protected weight bearing with crutches, LMWH chemoprophylaxis dose at least 6 hours post-operatively for 4 weeks, thigh length TED stockings for 6 weeks and foot pumps or flowtrons (calf compression devices) until mobile (Lex et al. Venous thromboembolism in orthopaedic oncology: risk factors, incidence, and prophylaxis. Bone Joint J 2020;102-B(12)1743:–1751 doi.org/10.1302/0301-620X.102B12.BJJ-2019-1136.R3)
Crutches 6 weeks, then wean to one crutch 6-12 weeks
Readmission for inpatient hydrotherapy after 6 to 8 weeks to facilitate weaning off crutches
3 post-operative doses of antibiotics
X-rays when safe, AP right proximal femur and hip
wound check 14 days, routine outpatients at 6 weeks, 6 months and then annually (unless the disease burden prevents regular clinic attendance)
Radiotherapy via oncologists after histology report and MDT discussion

British Orthopaedic Oncology Society – Metastatic Bone Disease: A guide to good practice. 2015
There are two aims in metastatic bone disease: the first is to prolong survival with oligometastatic disease; the second is to control pain and preserve function and avoid fracture. Any operation should outlive the patient i.e. no revision surgery due to mechanical failure should be required. In this patient the initial operation (long stem cemented total hip replacement) failed to address the primary aim. All patients with metastatic bone disease can be discussed with specialist orthopaedic oncologists at tertiary centres around the country, if only for advice remotely. Other guidelines described by the British Orthopaedic Oncology Society include never assuming that a bone lesion is solitary and if it is solitary after staging with CT chest/abdo/pelvis and whole body bone scanning, it should be referred to a specialist centre for biopsy.
Stevenson et al. Journal of Bone Joint Surgery 2018;100: 101-8.
Proximal femoral endoprostheses are durable and reliable reconstructions even in patients with comorbid conditions (Khajuria et al. Hip Int 2017) and recently were shown to have eliminated the risk of dislocation when used with hemiarthroplasty heads in the short term. Implant survival after five years is between 87% and 95%.
Henderson et al. Failure mode classification for tumour endoprostheses: retrospective review of five institutions and a literature review. Journal of Bone Joint Surgery Am 2011;93(5):418-29.
Causes of implant failure and revision include infection, aseptic loosening, dislocation, local tumour recurrence and structural failure. For the purposes of standardising the reporting of endoprosthetic related complications the Henderson classification is now used to subdivide the modes of failure into: soft-tissue failures (Type 1), aseptic loosening (Type 2), structural failures (Type 3), infection (Type 4), and tumor progression (Type 5)


Reference

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