Use of TEC system for amputees and other innovations in early management of the amputee Dr F Kohler 19th August 2005

Advantages of early fitting of prosthesis 1. Quicker stump maturation 2. Preservation of muscle tone 3. Prevention of contractures 4. Facilitates gait retraining 5. Eliminates bad walking habits

Goals of Post-operative Management of residual limbs 1) Primary wound healing 2) Prevention of oedema 3) Facilitation of stump shrinkage 4) Prevention of stump trauma 5) Patient education 6) Prevention of contractures

Timing for prosthetic treatment (A) temporary prosthesis ordered when (1) wound appears healed (2) sutures have been removed (3) stump is no longer oedematous (B) definite prosthesis (1) stump is no longer oedematous and measurements are stable over a period of time.

Current best practice 1. General conditions permitting the patient stands on day 1 or 2 post-operative for 1 to 5 minutes. 2. This is delayed in debilitated disorientated or obese patients and bed exercises are substituted. 3. Weightbearing is encouraged from day 1 or 2 but limited to less than 20kg (further restriction may be necessary). 4. Full weightbearing from when the wound is healed. 5. Ambulatory training commences when the patient can stand for > 5 minutes. (weightbearing restricted to 10kg).

GENERAL OUTLINE (preoperatively) Pre-operative Consultation Explanation of programme Psychosocial issues Upper limb/contra lateral limb exercise programme Mobilisation with aids

Perioperative Bed exercise programme Psychosocial aspects Plan early home visit Education of process

Postoperative (1) Day 2-3 - sit out of bed Day 4-5 - stand and commence mobility training. Day 4-5 - commence transfer practice. About 1 week - home visit.

Postoperative (2) Week 2 Progress to mobilising with aids Simultaneously may learn wheelchair independence, especially if TF amputee. Self care retraining

Postoperative (3) Week (3) Home visit with patient if required Stump bandaging if surgeon is happy Discharge home if possible Transfer to rehabilitation unit if required. - no home support - unsuitable home environment

Postoperative (4) After Week 3 Stump bandaging Temporary plaster prostheses as required Prosthetic training, usually as outpatient Definitive prosthesis about 3-4 months post amputation

New Innovations TEC stump protection fitted week 2 ICEX socket Osseointegration Polymer impregnated socks and removable rigid dressing

Definition TEC stands for Total Environmental Control referring to the total skin contact, and the pressure relieving properties of the system. 3

Components of the TEC system The system consists of TEC liner TEC stump socket TEC retainer 4

TEC Liner (1) made of urethane has flow properties to decrease pressure areas liner ‘flows’ from areas of high pressure to areas of lower pressures to even out pressure on the stump pre-shaped available in four different sizes comes with or without cover 5

TEC Liner (2) 7

TEC Liner (3) 8

TEC Socket prefabricated, 4 sizes adjustable to accommodate stump changes firm to protect from impact of falls or trauma 6

TEC Retainer Socket fits directly into retainer to which a pylon and foot can be attached in order to allow early mobilisation. 10

TEC Protector 9

Advantages 1) Stump protection 2) Earlier and better stump shaping 3) Enhances stump healing by assisting with management of oedema 4) Earlier mobilisation 5) Ease of review 11

Disadvantage of TEC System May not fit well on all stumps as premoulded, not individualised May not fit well secondary to the stump changes. Cost, about $1000 per prosthesis and liner.

Implications (1) Since it has been used, 2 patients who have had a significant fall onto their stump have not sustained any wound breakdown, unlike the 3 patients before use of TEC system, who required stump revision for 1 patient, conversion to above knee amputation for 2 patients. 12

Implications (2) Patients can now get up about day 7, compared to day 14-21 prior to use of this earlier mobilisation results in earlier discharge possibly a shorter time to definitive prosthesis 13

Economics Cost: Approximately $1000 per system can be sterilised and reused - 2,3 or more times. Savings: Unspecified, but likely to be many times the outlay. Currently studying to quantify savings Significant improvement in patient wellbeing. 14

                                                        

Look at my new Flex-Foot Barnaby is a 12-year-old horse from the UK. Happily, pioneering surgery and assistance from Dorset Orthopaedic meant Barnaby didn't have to be put down following an infection in his foot.

ICEX ICEX 100 is an integral part of the Icelandic Direct Casting (IDC) system, the unique direct casting system to make customized carbon fiber sockets directly onto the residual limb. The direct casting system allows prosthetists to produce well fitting sockets time and time again.

ICEX 2 ICEX 100 Superior comfort and fit IDC provides a Total Surface Bearing ICEX socket through even pressure distribution Strong and durable The ICEX 100 carbon fiber braid fits users of all activity levels upt to 100 kg. in weight Lightweight Carbon fibers are the strongest and most lightweight casting material available

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Polymer impregnated sock Thin thermoplastic/silicone type sock Lightweight removable rigid dressing Decreases shear forces Good stump compression Results suggest that stump stability for fitting of prosthesis is decreased from 17 to 12 days

Patients with TEC protector (1) JK: 55 year old lady - bilateral PVD, malunion following trauma - lives in caravan - etoh abuser with cerebellar signs - ® TT amputation 8/12/99 - Transfer to rehab. 22/12/99 - stump protector fitted 5/1/2000 - Independently mobile with prostheses and crutches - quad stick including steps on discharge 24/1/2000 - ongoing outpatient PT & support - now needs three distal pads in prosthesis

Patients with TEC protector (2) DR: 86 year old lady living alone at home (self care unit). PVD; IHD; # (L) wrist whilst on gate leave 12/11 (l) TT amputation 27/7, slow to heal, bed rest 3/52. Home to daughter’s house, independent with mobility on pick up frame Awaiting wound healing on 10/9/99 Admit to Braeside Rehab 21/10/99 and TEC liver. TEC prostheses fitted 25/10 - mobilising up to 150m outside with 2 crutches by 12/11 Had fall whilst transferring into car 14/11 Discharged home 24/11

Patients with TEC protector (2) DR: 86 year old lady living alone in self care unit; PVD; IHD; # (L) wrist whilst on gate leave 12/11 (l) TT amputation 27/7, slow to heal, bed rest 3/52. Home to daughter’s house, independent with mobility on pick up frame while awaiting wound healing on 10/9/99 Admit to Braeside Rehab 21/10/99 and TEC liver. TEC prostheses fitted 25/10 - mobilising up to 150m outside with 2 crutches by 12/11 Had fall whilst transferring into car 14/11 Discharged home 24/11 definitve fitted mid December still fitting well on last review 7/2/2000

TEC Patients (3) Mrs. MD - IDDM Bilateral TT amputations (L) 11/11/99 Poor wound healing - skin graft on left; slow healing on right; MRSA infection peripheral neuropathy CCF, IHD Transferred to Rehab 5/1/2000 - primary goal: Wheelchair independence achieved by 25/1. - Whilst awaiting home modifications (R) wound healed and a plaster prostheses was fitted on 27/1 - 28/1 standing practice and swivel transfers.

MD (2) 11/2 left TEC prostheses fitted 14/2 mobilised with prostheses x 2, FASF and assist x 2 15/2 - discharged

MD (3) 11/2 (l) TEC prostheses 14/2 mobilised with prostheses x 2, FASF and assist x 2 15/2 - discharged

TEC Patients (4) Mr AL, PVD, heavy smoker, lives on first floor (R) TT amputation 27/9 Fall 19/10 and placed on bed rest 28/10 mobilised with stump protector only 4/11 discharge home on cruches Readmitted 21/11 with abscess (R) TF amputation 17/12 Admit rehab 10/1 D/c Home 21/1on crutches

TEC Patients (5) Mr RC vasculopath, diabetic,obese (R) TF amputation 17/8 Fall end of August resulting in wound dehiscence and resuturing Stump protector only fitted early September Transferred to Rehab St Elsewhere wthout stump protector on 22/9 fall on 29/9 requiring resuturing (R) TT amputation 30/9

RC (2) Transfer to Rehab 7/10 commence prosthetic training 15/10 stump ooze increasing 22/10 recommence prosthetic training 28/10 independent with rollator frame 22/11 home mods required; discharge 3/12 definitive prosthesis fitted in January 2000

TEC Patients (6) Mr RK: PVD, AAA, smoker (R) TT amputation 21/10 Stump protector only fitted 2/11 Discharged home 2/11 hopping with PUF 17/11 mobilised with temporary TEC prosthesis 25/11 progressed to Canadian crutches 13/1 Definitive prosthesis fitted 4/2 minor adjustment to definitve prosthesis

Traditional (local) timing for prosthetic treatment (A) temporary prosthesis ordered when (1) wound appears healed (2) sutures have been removed (3) stump is no longer grossly oedematous (B) definite prosthesis (1) stump is no longer oedematous and measurements are stable over a period of two to four weeks

Local Study Retrospective analysis of first 30 patients with TEC prosthesis and a sample of amputee patients for two years prior to using the TEC system.

Study Aim Compare retrospective samples of patients by: Age Time taken to first get out of bed Time taken to first mobilise Time taken to first temporary prosthesis Time taken to mobilising independently Time taken to discharge and or transfer to a rehabilitation unit Time taken to definitive prosthesis Number of falls and consequences of falls

Method Retrospective chart analysis Patient identification by - 1) referral book 2) consult sheets 3) case conference lists

Inclusion criteria Transtibial amputation previously walking cognitively able to participate with rehabilitation programme

Exclusive criteria Grossly incomplete data severe dementia Other: morbidities excluding participation in rehabilitation programme stump revision

Results (1) TEC used in 30 patients 6 patients no data available - transferred to other hospital soon after TEC issue 24 patients for analysis

Results (2) Comparison Group 40 - 8 deleted because of lacking data 32 remaining for analysis

Results (3)

Results (4)

Results (5)

Falls outcomes with TEC TEC liner not worn 10 days lost due to bruising Patient fell while not wearing TEC resulting in wound breakdown, required re-suturing and three weeks to heal 2 falls in one patient, one resulting in no complications, one resulting in a fractures arm Patient developed fractured ribs No stump damage

Falls outcomes without TEC wound breakdown requiring one weeks bed rest and three weeks to heal wound breakdown and subsequent infection requiring conversion to AKA no complications 3 patients developed bruising to stump from fall delaying prosthetic fitting by 10 days or more

Analysis (1) Data not normally distributed Mann-Whitney test used for statistical analysis Not significant were: time to first get out of bed time to first mobilising time to discharge time to transfer to rehabilitation unit

Analysis (2) Highly significant differences for: first mobilising with prosthesis independent with prosthesis Approaching significance: Temporary Prosthesis first issued (0.057)

Conclusion Tec stump protectors result in improved patient outcomes as measured by earlier independence in prosthetic mobility There was a decreased incidence of serious stump trauma in patients who used the TEC protector. There is no evidence from this study that there were significant other effects on patient management

Economic Consequences of Falls Difficult to determine accurately but the stump revision required after the fall in the patient not wearing a TEC protector sways the costs markedly against not using a TEC liner or other protective device. So far only 2 events with stump damage in the TEC protectors At a hospitalisation cost of around $700 or more per day the cost/benefit ratio of TEC protectors seems favourable.

Discussion Need for further studies/greater numbers to fully evaluate outcomes. Need to review patient and staff satisfaction/acceptability Changes in surgeons expectations. No TEC=no mobilisation Cost of protectors and who pays? Reuse of protectors and effect on cost. Other possible effects on results.

Prosthetist involvement in making of temporary prosthesis This group consisted of amputees who were transferred to the Braeside inpatient rehabilitation unit from May 2003 onwards. The prosthetist reviewed the patients and made their temporary prosthesis while they were inpatients at Braeside. The data was collected prospectively.

Results (1) A total of 11 transtibial amputees were treated in the prosthetist group. One patient discharged themselves against medical advice and was excluded from the analysis as many of the end points were not met. This patient had progressed quite well prior to discharge. This left ten patients who were analysed as part of the study.

Results (2)

Results (3)

Results (4)

HISTORY

1961 Berlemont: immediate prosthetic limb replacement on the operating table applied plaster of paris following debridement of the infected and septic stump weight bearing allowed early in the post-operative period 1963 Weiss - modified and improved the technique using it for closed lower extremity amputations and surgical stump revisions

1967 - Burgess & Romano indicated that immediate post surgical prosthetic fitting had a significant positive effect on the plan of management confirmed as useful treatment by Moore (1968), Condon & Jordan (1969) Lim et al suggested the success was due to the rigid dressing, rather than early mobilisation Sormiento (1970) recommended that full weightbearing be prohibited for at least 2 weeks after amputation.

Kiah et al (1970) demonstrated faster wound healing decreased complication rate reduced hospital length of stay This was as a consequence of using rigid dressings without prosthetic Gerhardt & Assoc. (1970) advocated the use of an immediate post-operative fitting to achieve better soft tissue healing in addition to help control post surgical oedema, reduce pain and prevent the complications of inactivity.

Mooney & co-workers (1971) demonstrated that application of a functional, mechanical stress by means of progressive controlled weightbearing is beneficial in the soft tissue healing of the stump wound. - also demonstrated that early ambulation (< 1 month) post-operative) provided some physical or mental advantages to the patients, which allowed them to become functional prosthetic users to a greater degree

Cohen et al (1974) This immediate post-operative prosthesis technique had a tenfold increased incidence of wound complication Nicholas et al (1976) showed that the rigid dressing resulted in 100% healing of stumps by primary intention, compared to 78% primary healing in their conventional dressings (published figures 60-80%)

Mid 1970s it was generally felt that immediate post-operative prosthesis should be reserved for patients undergoing amputations for trauma or tumour, and the occasional good risk artheroschlerotic amputee. Generally weightbearing is allowed from about 2 weeks post operation

Baker et al in 1977 showed that plaster dressing significantly shortened hospitalisation and enabled earlier rehabilitation. The patients with soft dressings, almost uniformly had stump oedema despite wrapping with an elastic bandage, the persistence of which postponed the beginning of gait training.

They allowed protective/partial weightbearing on parallel bars/crutches as early as the first post-operative day, but did not hesitate to discontinue weightbearing if the patient was unable to control weightbearing. They demonstrated that maintenance of knee range of motion, stair climbing, walking up and down ramps, and standing up and sitting down were facilitated by this process, especially in the geriatric patient.

Wu & Assoc. (1979 &1980) first described a removable rigid dressing technique The below-the-knee removable rigid dressing is a below-the-knee plaster cast held by a suspension stockinette to a supracondylar plastic cuff. Being removable, it permits frequent observation and progressive shrinkage of the stump (by adding socks), and eliminates the need of elastic stump bandaging.

In addition, it still maintains the advantages of immobilisation of soft tissue (to reduce pain and facilitate wound healing) and prevention of trauma to the stump as does the conventional rigid dressing. It has significantly reduced the incidence of pre-tibial skin breakdown and distal oedema, produced fast stump shrinkage, and shortened time to ambulatory discharge with a temporary prosthesis by ninety days. Bacon et al (1986) described a detachable cast pylon technique for rigid dressing. The pylon could be removed at night, with the rigid dressing left insitu

Rehabilitation time following amputation (Wu et al 1979) Average time to healing (days) Average time to ambulatory discharge (days) Control group 109.5 191.4 Removable rigid dressing 46.2 101.8

Stump trauma (1991) Behan et al U.S. Retrospective review of below knee amputees for 14 years 23 suffered trauma to their stumps 80% of the trauma was as a result of a fall 11 patients required above knee amputation

Plaster Pylon Technique Harrington et al 1984 &1991 used a rigid plaster dressing applied in theatre to mid thigh level the patient is allowed to mobilise immediately with walker or crutches at one week plaster is changed and a copper tube pylon is added to the cast the patient is then allowed to partial weightbear or fully weightbear

Plaster Pylon Techniques Results (56 patients) Average time for wound healing (days) Average time for mobilisation with temporary prosthesis Plaster Pylon Group 40.4 108.4 Soft bandage Group 98.4 200.1

Open stump wounds Study by Vigier (France) et al 1999 Plaster cast socket with silicone sleeve versus elastic compression 28 subjects per group Average healing time (days) Walking with prosthesis Discharge Plaster cast 71.2 63.5 99.8 Elastic comp ression 96.8 73.3 129.9

Preformed temporary sockets First suggested by Foort in 1970 Further advocated by McDougall in 1977 who used transparent plastic sockets with foam/rubber pads. Three different diameters were available. This resulted in improved outcomes including healing of stumps which had been thought to require revision (Case series of 650)

Other types of temporary prosthesis 1. Shrink plastic film (s film)Dowie, 1975 S.A. one case report walking at 3/52 post operatively 2. Air splint Burraclough et al 1977 Sydney 5 patients from 10 used the air splint with pylon and foot attached prior to changing to a conventional temporary prosthesis

Other types of temporary prosthesis (cont’d) 3. Prefabricated plastic limb - Kraker D, 1986, USA plastic, hollow form fitted over the conventional plaster dressing and cut to size. Usually applied about day 8 post operatively. Average definitive prosthetic fitting at 7.7 weeks (54 days)

Other types of temporary prosthesis (cont’d) 4. Otto Bock Prefab 5. TEC 6. Definitive type

Advantages of Rigid dressings 1. Control oedema 2. Support circulation 3. Minimises inflammatory reaction 4. Simplified nursing care 5. Positive effect on stump shaping 6. Decreased painful phantoms

Disadvantages of rigid dressings 1) inability to observe the stump except at cast change 2) inability to produce progressive stump shrinkage except at cast change 3) length of time needed during periodic cast removal and re-application 4) need for an experienced prosthetist (physiotherapist) at completion of surgery 5) resource intensive

Contraindications to Rigid Dressing 1. Local infection at the site of amputation 2. Large oedematous stump in which technical application and appropriate anchoring would present a problem