Timothy B. Rapp, M.D., Loyola University Medical Center Melissa Zimmel, Northwestern University

2004 Connective Tissue Oncology Society University of Washington Musculoskeletal Tumor Service

Endoprosthetic vs. “Condyle-Sparing” Endoprosthetic vs. “Condyle-Sparing” Intercalary Allografts for Distal Femoral Intercalary Allografts for Distal Femoral Osteosarcoma: A Comparison of Long-Osteosarcoma: A Comparison of Long-

Term Follow-upTerm Follow-up

Endoprosthetic vs. “Condyle-Sparing” Endoprosthetic vs. “Condyle-Sparing” Intercalary Allografts for Distal Femoral Intercalary Allografts for Distal Femoral Osteosarcoma: A Comparison of Long-Osteosarcoma: A Comparison of Long-

Term Follow-upTerm Follow-up

Timothy B. Rapp, M.D., Loyola University Medical CenterTimothy B. Rapp, M.D., Loyola University Medical CenterMelissa Zimmel, Northwestern UniversityMelissa Zimmel, Northwestern University

Ernest U. Conrad III, M.D., University of WashingtonErnest U. Conrad III, M.D., University of Washington

Presented by Dr. Conrad at the Presented by Dr. Conrad at the Connective Tissue Oncology SocietyConnective Tissue Oncology Society

Annual Meeting, NovemberAnnual Meeting, November 2004 2004Montreal, CanadaMontreal, Canada


Reconstructive OptionsReconstructive OptionsReconstructive OptionsReconstructive OptionsEndoprosthetic replacementEndoprosthetic replacement10-year implant survival ~70%10-year implant survival ~70%Concern over bone stock long termConcern over bone stock long term

Osteoarticular allograftsOsteoarticular allograftsKnee instabilityKnee instabilityAllograft complicationsAllograft complications

““Condyle-Sparing” intercalary allograftsCondyle-Sparing” intercalary allograftsPreserves native knee jointPreserves native knee jointAllograft complicationsAllograft complications


ALLOGRAFT: HISTORICALALLOGRAFT: HISTORICALALLOGRAFT: HISTORICALALLOGRAFT: HISTORICAL

Mankin JBJS 1997Mankin JBJS 1997 104 intercalary allografts for malignancy, retrospective104 intercalary allografts for malignancy, retrospective

• 84 % “successful”84 % “successful”• Overall salvage rate 92%Overall salvage rate 92%• Local recurrence 9%Local recurrence 9%• Survival for high grade tumors 60%Survival for high grade tumors 60%• High non-union rate 28%High non-union rate 28%• Deep infection rate 12%Deep infection rate 12%• Outcome not affected byOutcome not affected by

Age, gender, anatomical site, length of graftAge, gender, anatomical site, length of graft

• Outcome adversely affected byOutcome adversely affected byInfection, fracture, stage of lesion, use of chemotherapyInfection, fracture, stage of lesion, use of chemotherapy

Mankin H, JBJS, 79-A 1997


Distal Femur- Bone Allograft: Distal Femur- Bone Allograft: Osseous Union??Osseous Union??

Distal Femur- Bone Allograft: Distal Femur- Bone Allograft: Osseous Union??Osseous Union??


REVISIONS=50% !?REVISIONS=50% !? NOT 25-30%NOT 25-30% ANDAND

15 YR OLD PT.15 YR OLD PT. REVISEDREVISED @@ Age 25/35/??Age 25/35/?? or Age20/25/30?or Age20/25/30?

LIMB SALVAGE REVISIONS?


Overall “Implant Survival “Overall “Implant Survival “ Adults Adults vs Children (N=88)vs Children (N=88)

Overall “Implant Survival “Overall “Implant Survival “ Adults Adults vs Children (N=88)vs Children (N=88)


LIMB SALVAGE “HYPOTHESIS”LIMB SALVAGE “HYPOTHESIS”CONDYLE SPARING GRAFTCONDYLE SPARING GRAFT

SUPERIOR TO IMPLANT ?SUPERIOR TO IMPLANT ?

LIMB SALVAGE “HYPOTHESIS”LIMB SALVAGE “HYPOTHESIS”CONDYLE SPARING GRAFTCONDYLE SPARING GRAFT

SUPERIOR TO IMPLANT ?SUPERIOR TO IMPLANT ?


““MATCHED REVIEW” OF MATCHED REVIEW” OF OSTEOSARCOMA OFOSTEOSARCOMA OFTHE DISTAL FEMURTHE DISTAL FEMUR

““MATCHED REVIEW” OF MATCHED REVIEW” OF OSTEOSARCOMA OFOSTEOSARCOMA OFTHE DISTAL FEMURTHE DISTAL FEMUR


CRITERIA:OSTEOSARCOMA- CRITERIA:OSTEOSARCOMA- DISTAL FEMUR -GRAFTS vs DISTAL FEMUR -GRAFTS vs

JOINTSJOINTS

CRITERIA:OSTEOSARCOMA- CRITERIA:OSTEOSARCOMA- DISTAL FEMUR -GRAFTS vs DISTAL FEMUR -GRAFTS vs

JOINTSJOINTS ISSUES:ISSUES: ADEQUATE OSSEOUS MARGIN (vs SOFT TISSUE)ADEQUATE OSSEOUS MARGIN (vs SOFT TISSUE) ALLOGRAFT vs IMPLANT @ DISTAL FEMURALLOGRAFT vs IMPLANT @ DISTAL FEMUR


MethodsMethodsMethodsMethodsIRB Approved review of Allografts IRB Approved review of Allografts and Implants 1990-2002and Implants 1990-2002

SARCOBASE + Chart ReviewSARCOBASE + Chart Review SurvivalSurvival Local recurrenceLocal recurrence Surgical complications/revisionsSurgical complications/revisions

Functional AssessmentFunctional Assessment Modified MSTS/SF-36Modified MSTS/SF-36

Careful X-ray ReviewCareful X-ray Review


ALLOGRAFTS- OVERALLALLOGRAFTS- OVERALLALLOGRAFTS- OVERALLALLOGRAFTS- OVERALL

1990- 20011990- 2001

N=80/73N=80/73

Mean age= 28 yrsMean age= 28 yrs

Mean F/U= 5.3yrsMean F/U= 5.3yrs

Site=Femur/tibia/pelvisSite=Femur/tibia/pelvis

42/22/16%42/22/16%

Grafts= NTCGrafts= NTC


OVERALL ALLOGRAFT-OVERALL ALLOGRAFT-RESULTSRESULTS

OVERALL ALLOGRAFT-OVERALL ALLOGRAFT-RESULTSRESULTS

RADIOGRAPHIC REVIEW=RADIOGRAPHIC REVIEW=

“ “ NONUNION”=39%NONUNION”=39%

DELAYED UNION=10%DELAYED UNION=10%

TIME TO UNION= 14.6mosTIME TO UNION= 14.6mos

OTHER:OTHER:

FRACTURE= 5%FRACTURE= 5%

INFECTION= 5%INFECTION= 5%

REVISION=40%REVISION=40%


Allografts:New FixationTechniques vsImmunologic-BiologicGraft Issues


IMPLANTS- OVERALL REVIEWIMPLANTS- OVERALL REVIEWIMPLANTS- OVERALL REVIEWIMPLANTS- OVERALL REVIEW

1986-2002 N=881986-2002 N=88 AGE= 9-86 yrs mn=33yrsAGE= 9-86 yrs mn=33yrs Pediatric age =31/88Pediatric age =31/88 Follow-up=70 mosFollow-up=70 mos Anatomic=Femur/TibiaAnatomic=Femur/Tibia =61/27=61/27 FunctionalAssess=MSTS FunctionalAssess=MSTS /SF 36/SF 36


Radiographic OutcomeRadiographic OutcomeRadiographic OutcomeRadiographic Outcome

Xrays scored in 3 major categoriesXrays scored in 3 major categoriesContinuous cement mantle (2mm)Continuous cement mantle (2mm)No lucencies > 1mmNo lucencies > 1mmCortical bridging from bone to collarCortical bridging from bone to collar

Mean xray score 75/100 Mean xray score 75/100 Lower “cement mantle” and “lucency” Lower “cement mantle” and “lucency”

scores associated with pain and the need for scores associated with pain and the need for revisionrevision

““Bone bridging” did not correlate with Bone bridging” did not correlate with revision status!revision status!


Statistical MethodsStatistical MethodsStatistical MethodsStatistical Methods

Patient and prosthetic Patient and prosthetic survivorship curves by survivorship curves by Kaplan-Meier methodKaplan-Meier method

Student t tests to compare Student t tests to compare radiographic groupsradiographic groups


OVERALL IMPLANTOVERALL IMPLANTRESULTSRESULTS

OVERALL IMPLANTOVERALL IMPLANTRESULTSRESULTS

RADIOGRAPHIC:RADIOGRAPHIC:

“ “ Aseptic Loosenening”=19%Aseptic Loosenening”=19%

Other:Other:

Implant Failure= 12.5%Implant Failure= 12.5%

Revision=55%Revision=55%

Major=40.6% Minor=59.4%Major=40.6% Minor=59.4%

Pediatric Prox Tibia p=0.029Pediatric Prox Tibia p=0.029


Overall Complications=50% Overall Complications=50% --Knee stiffness: 10 pts --Knee stiffness: 10 pts

Deep infection: 7 ptsDeep infection: 7 ptsSuperficial wound: 6 ptsSuperficial wound: 6 ptsNerve palsy: 7 ptsNerve palsy: 7 ptsBushing failure: 6 ptsBushing failure: 6 ptsStem fracture: 5 ptsStem fracture: 5 ptsPatella instability: 4 ptsPatella instability: 4 ptsDVT/PE: 3 ptsDVT/PE: 3 ptsMAJOR vs MINOR COMP’SMAJOR vs MINOR COMP’S

Overall Implant Complications


GOOD NEWS-BAD NEWS !GOOD NEWS-BAD NEWS !GOOD NEWS-BAD NEWS !GOOD NEWS-BAD NEWS !

PEDIATRIC PEDIATRIC SURVIVAL IS SURVIVAL IS BETTER THANBETTER THANIMPLANT IMPLANT SURVIVAL !?SURVIVAL !?( “GOOD RESULT “=( “GOOD RESULT “= GOES SKIING ?? )GOES SKIING ?? )


Clinical OutcomeClinical OutcomeClinical OutcomeClinical Outcome

SF-36SF-368 standard categories assessed8 standard categories assessed

• Physical functioning, Role Physical functioning, Bodily Physical functioning, Role Physical functioning, Bodily Pain, General Health, Vitality, Social Functioning, Role Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental HealthEmotional, Mental Health

Knee implant population scores lower than general Knee implant population scores lower than general U.S. population in each category, but NOT U.S. population in each category, but NOT statistically significantstatistically significant

• Differed most in physical function and bodily pain Differed most in physical function and bodily pain categoriescategories


Results -”Matched” Distal FemurResults -”Matched” Distal Femur Allograft vs Implant Allograft vs Implant

Results -”Matched” Distal FemurResults -”Matched” Distal Femur Allograft vs Implant Allograft vs Implant

45 patients between 1989-2000 treated for a 45 patients between 1989-2000 treated for a distal femoral (meta-diaphyseal) osteogenic distal femoral (meta-diaphyseal) osteogenic sarcomasarcoma All patients received neoadjuvant chemotherapyAll patients received neoadjuvant chemotherapy

27 patients- “condyle-sparing” allograft27 patients- “condyle-sparing” allograftAverage age 18.1 yearsAverage age 18.1 yearsAverage follow-up 6.5 yearsAverage follow-up 6.5 years

18 patients - primary endoprosthesis18 patients - primary endoprosthesisAverage age 13.8 yearsAverage age 13.8 yearsAverage follow-up 6.4 yearsAverage follow-up 6.4 years


SurgicalResults-Matched SeriesSurgicalResults-Matched SeriesSurgicalResults-Matched SeriesSurgicalResults-Matched Series““Condyle-Sparing” Allografts (n=27)Condyle-Sparing” Allografts (n=27) Ten (37%) patients revised to endoprosthesisTen (37%) patients revised to endoprosthesis

• Average 3.5 years after original allograftAverage 3.5 years after original allograft• Eight cases due to allograft/host non-unionEight cases due to allograft/host non-union

Average of 3.3 revision procedures/ptAverage of 3.3 revision procedures/pt• Bone grafting/screw or nail exchangeBone grafting/screw or nail exchange

Two deep infections (both eventually converted to implant)Two deep infections (both eventually converted to implant) One amputation for local recurrenceOne amputation for local recurrence

Endoprosthesis (n=18)Endoprosthesis (n=18) Four (22%) patients revisedFour (22%) patients revised

• Average 4.8 years after index procedureAverage 4.8 years after index procedure Average of 1.1 revision procedures/ptAverage of 1.1 revision procedures/pt Three deep infectionsThree deep infections One amputation for pain/stiffOne amputation for pain/stiff


Oncologic Results-Matched SeriesOncologic Results-Matched SeriesOncologic Results-Matched SeriesOncologic Results-Matched Series

Overall Survival 84% Overall Survival 84% Four deaths in allograft groupFour deaths in allograft groupThree deaths in endoprosthesis groupThree deaths in endoprosthesis group

Local RecurrencesLocal RecurrencesTwo in allograft group (avg. 15 months after surgery)Two in allograft group (avg. 15 months after surgery)One in endoprosthesis group (five months after surgery)One in endoprosthesis group (five months after surgery)

Surgical Osseous MarginsSurgical Osseous MarginsAllograft=2.7cm(prox)+1.5cm(distal) ave bone marginAllograft=2.7cm(prox)+1.5cm(distal) ave bone margin

Endoprosthesis=3.1cm(prox)=2.6cm(distal-jt) ave Endoprosthesis=3.1cm(prox)=2.6cm(distal-jt) ave marginmargin


Functional Results-Matched SeriesFunctional Results-Matched Series Functional Results-Matched SeriesFunctional Results-Matched Series

PainPain Allografts (n=17): No narcoticsAllografts (n=17): No narcotics Endoprosthesis (n=18): One patient required occasional narcoticsEndoprosthesis (n=18): One patient required occasional narcotics

Walking AidsWalking Aids Allografts: Two patients using canes, one uses crutches for long Allografts: Two patients using canes, one uses crutches for long

distancedistance Endoprosthesis: One patient using cane, one uses crutches for long Endoprosthesis: One patient using cane, one uses crutches for long

distancedistance

ROMROM Allografts: One flexion contracture (10º); average motion arc 105ºAllografts: One flexion contracture (10º); average motion arc 105º Endoprosthesis: Three contractures (avg. 15º); avg. motion arc 110ºEndoprosthesis: Three contractures (avg. 15º); avg. motion arc 110º

StrengthStrength Allograft: Four patients with 4/5, otherwise 5/5Allograft: Four patients with 4/5, otherwise 5/5 Endoprosthesis: Three patients with 4/5, otherwise 5/5Endoprosthesis: Three patients with 4/5, otherwise 5/5


Clinical OutcomeClinical OutcomeClinical OutcomeClinical Outcome

SF-36SF-36 8 standard categories assessed8 standard categories assessed

• Physical functioning, Role Physical functioning, Bodily Pain, General Physical functioning, Role Physical functioning, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental HealthHealth, Vitality, Social Functioning, Role Emotional, Mental Health

Knee implant population scores lower than general U.S. Knee implant population scores lower than general U.S. population in each category, but NOT statistically significantpopulation in each category, but NOT statistically significant

• Differed most in physical function and bodily pain categoriesDiffered most in physical function and bodily pain categories

MSTS=63% GOOD + EXC / Grafts= ImplantsMSTS=63% GOOD + EXC / Grafts= Implants““TESS” IS BETTER ?TESS” IS BETTER ?


GOOD NEWS-BAD NEWS !GOOD NEWS-BAD NEWS !GOOD NEWS-BAD NEWS !GOOD NEWS-BAD NEWS !

PEDIATRIC PT. PEDIATRIC PT. SURVIVAL IS SURVIVAL IS BETTER THANBETTER THANIMPLANT SURVIVAL IMPLANT SURVIVAL

ORTHOPAEDIC ORTHOPAEDIC CHALLENGECHALLENGE


Discussion-Matched Series@5yrsDiscussion-Matched Series@5yrsDiscussion-Matched Series@5yrsDiscussion-Matched Series@5yrs

Endoprosthesis vs. “Condyle-Sparing” AllograftsEndoprosthesis vs. “Condyle-Sparing” Allografts::Tumor control -similarTumor control -similar SurvivalSurvival Local recurrenceLocal recurrence

Final Functional - Similar??Final Functional - Similar?? Pain meds, walking aids, strength, ROMPain meds, walking aids, strength, ROM

Higher Failure Rate in AllograftsHigher Failure Rate in AllograftsREVISION RATE=37 vs 22% (GRAFTS vs IMPLANTS)@4-5 yrsREVISION RATE=37 vs 22% (GRAFTS vs IMPLANTS)@4-5 yrs


LIMB SALVAGE- FUTURE?LIMB SALVAGE- FUTURE?LIMB SALVAGE- FUTURE?LIMB SALVAGE- FUTURE?

EndoprosthesisEndoprosthesis FOCUS ON 10 YR RESULTS +PATTERNS OF FAILUREFOCUS ON 10 YR RESULTS +PATTERNS OF FAILURE ISOLATE +IMPR0VE REVISION SCENARIOISOLATE +IMPR0VE REVISION SCENARIO CONSIDER NEW STEM FIXATION IN CHILDRENCONSIDER NEW STEM FIXATION IN CHILDREN FOCUS ON CAUSES OF FAILUREFOCUS ON CAUSES OF FAILURE

““Condyle-sparing” allograftsCondyle-sparing” allografts CLEARLY HAVE HIGHER FAILURE RATE-EARLY(5YRS)CLEARLY HAVE HIGHER FAILURE RATE-EARLY(5YRS) EMPHACIZE FIXATION TECH’SEMPHACIZE FIXATION TECH’S CLOSE BUT CAUTIOUS BONY MARGINCLOSE BUT CAUTIOUS BONY MARGIN TIME TO UNION=14 monthsTIME TO UNION=14 months ALLOGRAFT BIOLOGY IN THE FUTURE?ALLOGRAFT BIOLOGY IN THE FUTURE?

ALL LIMB SALVAGE PATIENTSARE DONE ON “PROTOCOL”


THANK YOU


Thank you for your attention!Thank you for your attention!Thank you for your attention!Thank you for your attention!

Research supported by Research supported by educational grants from educational grants from Stryker Howmedica Stryker Howmedica Osteonics, Inc. and Osteonics, Inc. and Zimmer, Inc.Zimmer, Inc.


Thank YouThank YouThank YouThank You


Implant OverallImplant OverallImplant OverallImplant Overall

Implant group overall (n=88)Implant group overall (n=88)

““Implant survival”Implant survival”At five yearsAt five years == 71%71%At ten yearsAt ten years == 59%59%

InfectionInfection == 7%7%

Aseptic LooseningAseptic Loosening == 19%19%


Overall Implant Survival RateOverall Implant Survival Rate Adults vs. Adults vs. Children (N=88)Children (N=88)

Overall Implant Survival RateOverall Implant Survival Rate Adults vs. Adults vs. Children (N=88)Children (N=88)


““LIMB SALVAGE “LIMB SALVAGE “They do well ?They do well ?

““LIMB SALVAGE “LIMB SALVAGE “They do well ?They do well ?

BEWARE THE SUBTLETIES !!

Timothy B. Rapp, M.D., Loyola University Medical Center Melissa Zimmel, Northwestern University

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