Dr N Purushothama Rao

MS Orth, MCh Orth UK.,MRCS Glasgow MRCS Edinburgh

Senior Resident in Orthopaedics,
Government General Hospital/ Rangaya Medical College, Kakinada

Prof Dr Y Nageswar Rao MS Orth,

Professor and Head of the Dept Orthopaedics, RMC/GGH Kakinada Asst Prof: Dr M Vittal MS Orth, Dr Shyam Sundar MS Orth, Dr Pardhasardhi MS Orth, S/R :Dr Aditya Krishna MS MCh Orth, PGs: Dr Seshagiri, Dr Aziz

Disclosures

Not funded by any Surgical Industry

Not received any grants

Squatting

OUTLINE

Introduction Principles of TKR

Design rationale of Indus Knee

Purpose of our study, Materials & Methods Results & Discussion Conclusion

Introduction
TKA is one of the most successful and the best results for TKA at 10 15 yrs. compare to or surpass the best result of THA.

Nearly 30000 people undergo joint replacements in India per year with a 25% increase each year.

Knee osteoarthritis is the commonest indication for joint replacement.

Is there a need for development of

a knee prosthesis for an Asian population

Femur size of Asians differs from that of Caucasians

TJ P Implants designed & manufactured to accommodate the knee anatomy of Western Caucasians, not Asians , The smallest size from each Western prosthesis company is used, may be too big for some Asian subjects.

Chaichankul** and Cheng ##reported that Thai & Chinese population knees were mismatched and too
small, respctively, for several Western prostheses, it is likely that results would be similar to other Asian populations.

For Indian subjects, there is no clear evidence about how often incorrect sizing using Western prostheses occurs This limitation suggests the need for a prosthesis developed for an Asian population, such as the Indians, who often require a higher flexion for most of their daily social habits and customs

**Chaichankul C, Tanavalee A, Itiravivong P: Anthropometric measurements of knee joints in Thai population: correlation to the sizing of current knee prostheses. Knee 2011, 18:510. ##Cheng FB, Ji XF, Lai Y, Feng JC, Zheng WX, Sun YF, Fu YW, Li YQ: Three dimensional morphometry of the knee to design the total knee arthroplasty for Chinese population. Knee 2009, 16:341347

Design rationale of Indus Knee

The ethnic, anatomical & cultural variations in the Indian population have prompted the need for development of the INDUS Knee It is a posterior cruciate substituting design where femoral rollback occurs by a post & cam
mech.

Two design modifications allow maximal flexion at the knee

The radius of curvature of the posterior condyle of the femoral comp (J curve) has been reduced, thereby increasing the posterior condylar offset. The total thickness remains the same. The original offset is reproduced. This helps in gaining more femoral rollback and more flexion.

A 4 slope is incorporated in the tibial insert and a 3 slope in the metal base plate , a total of 7 Posterior Tibial Slope to aid in increase of flexion22 **
** Bellemans et al., The influence of tibial slope on maximal flexion after TKA.Knee Surg Sports Traumatol Arthrosc. 2005;13:1936

Introduction

The INDUS prosthesis is designed so as to keep the thickness of the posterior condyle equivalent to the thickness of the distal condyle. The cam and post have been placed in such a way that the removal of the box in the center is much less; hence, patellofemoral complications are much lower.

The purpose of this study is to analyze the short term follow-up results using the INDUS prosthesis.

Principles of TKR ABCD S

Alignment Balancing Correct Bony cuts, Component sizes, Cementation Deformity correction
(incl Patellar Tracking)

Sizing of components

Design rationale of Indus Knee

To attain Knee flexion

beyond 150 degrees

without compromising wear,

Polyethylene contact stresses, Patello femoral Tracking, or stability

Design Features of The INDUS Knee

The J curve modified- Posterior condyles design & thickness

1. The J curve is modified to a greater ROM 2. Posterior condyles a) Reduced radii of curvature b) Increase in thickness c) Requires additional resection of the posterior condyles

Design rationale of Indus Knee

Less Bone resection than the conventional PS Knee

Sloped Box
Proportional Box width 25% - 45% less bone resection
PS Knee INDUS Knee

Design rationale of Indus Knee

THE NEW 3RD ARTICULATING CONDYLE

Conforming Geometry between the Cam and the Post ( 3rd Condyle)
A third joint was designed between the post & the cam, with the post engaging the cam at around 80 of flexion and thereafter acting like a load bearing surface in deep flexion. The articulating surface of the post is convex & the cam is concave thus allowing a more congruent surface for allowing load transfer & the rotation to occur as the post does not impinge on the side walls of the box during rotations. This rotational freedom is necessary to prevent wear of the post hence loosening and osteolysis of the tibial component

Cam Post

**Mikulak et al., Loosening & osteolysis with the PFC , PC-substituting total knee replacement .JBJS 2001; 83A

Design rationale of Indus Knee

Jumping Dist. Edges Tibia Monoblock Small Femoral Box

The bar of the cam articulates with the post at a lower level, the jumping distance is increased to 16 mm, another feature to assist in enhanced stability.

1) The posterior edges of the tibial PE insert are chamfered to avoid impingement in deep knee flexion.

2) An anterior cutout in the tibial PE insert to accommodate the patellar tendon deep flexion

The tibia is monoblock & hence backside wear is reduced to a minimum, tibial PE insert has a deep dish design to prevent point loading poly wear.

In the INDUS design, the femoral box is designed so as to cut minimal bone there by incorporating the bone sparing principle.

Anatomic studies Suitable sizes for Indian population

Indus Knee

A thorough anatomic study of the Indian knee joints The components being in sizes that are more suited to the Indian population.

The various sizes were designed in accordance with the suggestions of Vaidhya et al.** and by analyses of 100 computerized tomography scans in 50 patients (independent unpublished data)
** Vaidya , Ranawat Anthropometric measurements to design total knee prostheses for the Indian population. J Arthroplasty. 2000;15:7985

The femoral components are separate for the right & left e deep Troch groove, open box for SC Nailing in case of Preprosthetic fracture

The patella is a single peg anatomic design

Design rationale of Indus Knee In conclusion

The INDUS knee is designed to be a high-flexion, Bone sparing and anatomic design suitable for the native population.

The prosthesis is Gamma irradiated in vacuum to increase the longevity of the polyethylene.

Principles of TKR ABCD S

Alignment Balancing Correct Bony cuts, Component sizes, Cementation Deformity correction
(incl Patellar Tracking)

Sizing of components

X rays - Templating
Important

Is there a need for Long leg radiographs in every TKR

A Study Pre Op Hip to Ankle Radiographs in TKA CORR 2004,404

McGrory et al A randomised prospective study 124 cases

No statistical difference

Long Leg radiographs definite Indicated

Varus > 15 Valgus Pre existing Femoral / Tibial Deformity Very Short/ tall / Obese patients

Short Radiographs TEMPLATING

STANDARD

Short X rays- Mech axis lacking

CUTS PLANNED

AP standing ( 14 X 17 film)

Lateral View
Patellar Skyline View Pelvis with both Hip Joins

Best available data

Certain assumptions

Successful Successful TKA TKA

Assessing the Results of Total Knee Replacement:

Pain Function Range of Motion Stability

Deformity

Ligament Balancing

Benefits to balancing the ligaments:

Optimize the results,
Recognize potential errors in bone resection and

soft tissue problems intraoperatively

Unbalanced knee
Stiff, loose painful

Premature wear
Early revision

It is essential to balance the ligaments if one is to use a mobile bearing knee

Bony Alignment

Varus, Valgus, Rotation, Translation, Flexion, Extension, Proximal, Distal

If we combine all of the possible malalignments we will note there are 11,684 methods to get it wrong and only one will have perfect alignment Lotke

Goals

Goals

Confirm Tibial Cut Neutral

MCL = LCL Flexion Gap = Extension Gap

Steps in TKA

Tibial Resection
Distal Femur Resection Femoral Antero-posterior Resection Ligament Balancing Femoral Finishing Cuts

Ligament Balancing Steps

Check Flexion Space

Check Extension Space Check Alignment Of Tibial Cut Resolve Discrepancies

Our study

Material & Methods, Results & conclusions

Purpose

To study a consecutive series of 18 pts ( 20 Knees) who had INDUS Knee prosthesis and evaluate and analyse the follow up results in short term ( 3-8 months- Ave 6 months) Discuss the suitability of the High flex knee designs ( INDUS Knee) for Asian patients

Materials and Methods

Twenty primary total knee arthroplasties in 18 patients using the INDUS knee prosthesis were prospectively enrolled in this study and were performed from August 2011 to February 2012, at Govt Gen Hospital, Kakinada.

We have followed of all 20 patients at first 6weeks, then 3 and 6 months. None had any serious complications, though we had 3 cases of swollen legs with no evidence of DVT(Doppler)

Dermographics

There were 12 men (13 knees) and 6 (7 knees) women with a mean age of 62 yr ( range 52-72). Two cases of bilateral TKR spaced at an average interval of 3 months 16 knees had OA, 4 Knees had rheumatoid arthritis.

Average Follow up of these 20 cases 6 months(3-8) and at each follow up visit we have assessed the clinical parameters, incl. the Knee Society scores, ROM, and complications were recorded.

Dermographics

All are Thro Med P P App.&

All are Cemented

Methods
uni in 90% 20) Staged Bil in 10%

Patella Resurfacing
Patelloplasty done in 90% ( 18 of Patella Resurfaced in 10%

Materials and Methods Operative procedure

An anterior midline incision, medial Parapatellar approach been used in all 20 cases. A combination of both measured resection and Gap balancing techniques been used for appropriate soft tissue balancing. All the components were cemented after pulsed lavage. Patelloplasty (peripatellar synovectomy, electrocautery of the patellar rim, and removal of osteophytes) rather than patellar resurfacing was performed in 18 knees when the articular cartilage was found to be healthy and Patellar tracking is satisfactory and only in 2 cases Patellar resurfacing done.

Materials and Methods

Operative procedure

Prophylactic antibiotics were given 30- 60 min before surgery. Intravenous antibiotics were continued for 10 days after surgery. Only in 3 cases we have made the patients to wear compression stockings for 12 weeks because of their excessive risk of DVT. A drain was used for 48 h. Active quadriceps-strengthening exercises and range of motion were commenced within 2 post-operative days and weight bearing was allowed from the second to third postoperative day. These was not any formal Physiotherapy, only surgeon guided and patient self motivated, but still could achive 90 within 4-6 days in 90% of patients.

Follow up and Results

The patients were reviewed at 6 weeks, 3 months, 6 months and few at 8 months. Clinical parameters, including the Knee Society scores (KSS),*** range of motion, post-operative clinical anterior knee pain and complications were recorded. The KSS was evaluated in two parts: first, the knee score involving the clinical knee findings, and, second, the function score analyzes functional mobility of the patient. In addition, patients were asked to squat or sit cross-legged at follow-up. Pre-operative factors affecting the post-operative ROM were also analyzed, including flexion contracture, deformity, and ROM. No subjective parameter was recorded.

***Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989;248:134

Knee society score :

Knee society score contd.

Results

Pre& Post OP radiographs incl AP &lateral were assessed for limb alignment, component positioning, and Loosening - any evidence of radiolucent
lines at the bone cement interface.

Statistical comparisons for such a small number of cases is not very relevant. We found greatly improved postoperative clinical scores compared to preoperative clinical scores.

Results
Average Follow Up 6 Months

At ave.Follow up of 6 months (36), the mean knee score and the mean function score were significantly improved from a pre-operative value of 40 points and 47 points to a postoperative value of 87 points and 86 points, respectively (P value <0.05).

Of 20 knees, 14 knees had flexion above 120-130 A total of 14 patients (14 knees, 70 %) could squat or sit cross-legged at the final follow-up.

Results
Flexion Range-ROM Of the 18 patients (20 knees), 14 knees had flexion > 120, 4 had a flexion range of 100110, and 2 had a flexion range of 90100 with the mean range of movement being 115.

a total of 14 patients (14 knees70 %) could squat or sit cross-legged at the final follow-up.

Results Mean tibiofemoral angle changed to 5.4 valgus Post Op cf with 10.5 varus Pre

Op

The mean tibiofemoral angle was 10.53.9 of varus pre OP and 5.42.2 of valgus (37 of valgus) at the final follow-up, with no loss of alignment noted in case.

Pre Op Post Op
A

No case for revision for early or late infection nor had any periprosthetic fracture.

Results Clinical Anterior Knee Pain Score

At the last follow-up, the clinical anterior knee pain scores were grade 0 (no pain) in 14 knees (70%), grade 1 (mild pain) in 5 knees (25%), and grade 2 (moderate pain) in 1 knee (5%); none were grade 3 (severe pain).

Results Pre-op, the mean flexion contracture was 13.3 (range, 1030), the mean maximum flexion was 114.83 (60120), and the mean ROM was 106.2 (45120). At the last follow-up, the mean flexion contracture was 3.19 (010), and the mean ROM was 115 (90130). These outcomes represent a satisfactory and significant improvement of ROM and movement were retained over time. No clunks / crepitus were heard

Pre & Post Op ROM

Pre Op A severe Varus def > 12-15 5

Post Op Excellent Correction Valgus-3-

Pre Op A severe Varus def > 15-20

Post Op Excellent Correction Valgus-3- 5

Post Op - Excellent Flexion and ROM

COMPLICATIONS

There

was no mortality in the series

cases minor Anterior Knee Pain ( 25%)

3 cases of Swollen Legs but no DVT ( 15%) 4 cases of Minor Fixed Flexion Deformity( 20%)

Discussion
Achieving maximal knee flexion improves the patient satisfaction & knee performance.,but conventional knee arthroplasty before highflex designs rarely allows for knee flexion beyond 120 The newer high-flexion knee replacement prostheses have reported a higher flexion achieved post-operatively, within a range of 130135 of flexion.4

Component sizing & proper components placement is the key to the success of knee arthroplasty.** Component oversizing in the AP dim. alters the delicate balance in F/E gap, resulting in flexion tightness Post Op because of increased tension in the quadriceps mechanism@ whereas oversizing in the mediolateral dim. affects the patellar tracking and wound closure.* The risk of component oversizing with the other available implants is esp. present in Indians & other Asian subpopulations that are known to have a smaller build and stature as compared with the western population. INDUS knee is based on careful assessment of anthropometric data from the Indian patients thus reducing the risk of oversizing.
**Goldberg et al., Technical consideration in total knee surgery: Management of patellar problems. OCNA. 1989;20:189 : @Ranawat CS. The patellofemoral joint in total condylar knee arthroplasty: Clin Orthop Relat Res. 1986;205:939 *Krackow KA. The technique of total knee arthroplasty. St Louis: CV Mosby; 1990.

Discussion
A number of modifications have been made in the post & cam mechanism of the INDUS knee to enhance flexion and increase stability in deep flexion

Han et al.** reported a high incidence of loosening of the femoral component in a retrospective series of 72 knees using the Legacy posterior stabilizedflex TKR. At a mean follow-up of 32 months, aseptic loosening of the femoral component was found in 27 (38%) cases, with 15 (21%) requiring revision at a mean of 23 months. They concluded that the high rate of loosening was associated with weight bearing at maximum flexion and inadequate support of the posterior condyle of the prosthesis.

In the INDUS knee, the modified post and cam functions as a load-bearing third joint & lend support to the posterior condyles during deep flexion. Our follow-up is short, but still have had no cases of mechanical loosening of either of the components. **Han et al., High incidence of loosening of the femoral component in legacy posterior stabilised-flex total knee replacement. J Bone Joint Surg Br. 2007;89:145761

Discussion

For conventional implants, the range of movement following TKRs is reported to be approximately 1101016 and few patients can flex beyond 120.4143 The excellent ROM observed in this study is consistent with the kinematic advantages of high-flexion implants demonstrated in several biomechanical studies.17,18,3134 The introduction of high-flexion prosthesis has raised concerns that the increased flexion which enables patients to squat or sit cross-legged may compromise the longterm results.19 There is also concern regarding loosening of the implant caused by design modifications requiring removal of more bone from the posterior femoral condyles and the intercondylar area.19,44

However, our study shows favorable results, with mean values of 115 flexion and excellent total and function KSS.
No revisions for aseptic loosening were required. There were no incidents of instability or dislocation in the deep flexion.

Sum up the Discussion

Max

K/B Pt satsfaction & Good performance

Hence

Hiflex Knees expected to do well Asian knees are developed to suit the correct sizes as well as to fulfil the demand of Hiflexion Design modf of Indus are mainly 3 1) Increased J curve
2) 3)

Incresed Tib slope ( 7 cf 3 ) Post & Cam act as 3rd Condyle Joint

Discussion

Strengths of this study are Single Type of Prosthesis, single Hospital, same set up, same surgical technique and similar surgeons, but weaknesses are limited number and shorter follow up. However, the prospective nature of our study allows us to follow these patients and we should be able to identify and correct any problems seen with this new design. We have so far 100% follow-up and we will report on medium and longer term results as they become available

Discussion

In the present series, total knee arthroplasty with the INDUS knee prosthesis resulted in an excellent range of motion and good functional outcome, and the durability of the prosthesis is promising.

Conclusion

We conclude we have found the solution (for our most needy arthritic patients who are not so rich) ie., INDUS Knee prosthesis

I Indigenious, Indian D Durable, Dependable E Efficient, Economical A Affordable, Asian L Long Lasting All in all its a NEW IDEA/ IDEAL Knee

References

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References

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References

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40. Han HS, Kang SB, Yoon KS. High incidence of loosening of the femoral component in legacy posterior stabilised-flex total knee replacement. J Bone Joint Surg Br. 2007;89:145761.[PubMed: 17998181] 41. Anouchi YS, McShane M, Kelly F, Jr, Elting J, Stiehl J. Range of motion in total knee replacement. Clin Orthop Relat Res. 1996;331:8792.[PubMed: 8895623] 42. Bellemans J, Banks S, Victor J, Vandenneucker H, Moemans A. Fluoroscopic analysis of the kinematics of deep flexion in total knee arthroplasty: Influence of posterior condylar offset. J Bone Joint Surg Br. 2002;84:503.[PubMed: 11837832] 43. Dennis DA, Komistek RD, Colwell CE, Jr, Ranawat CS, Scott RD, Thornhill TS, et al. In vivo anteroposterior femorotibial translation of total knee arthroplasty: A multicenter analysis. Clin Orthop Relat Res. 1998;356:4757.[PubMed: 9917667] 44. Ritter MA. High-flexion knee designs: More hype than hope? In the affirmative. J Arthroplasty. 2006;21:401.[PubMed: 16781427] Indian J Orthop. 2009 Oct-Dec; 43(4): 367374. The INDUS knee prosthesis Prospective multicentric trial of a posteriorly stabilized high-flex design: 2 years follow-up Kantilal H Sancheti, Nandu S Laud, Gurava Reddy, et al

Dedicated to all those who could understand the suffering of poor arthritic patient, like we do at GGH

(hopefully you all will join hands with us to help those in the near future)

Thanking You