biologic knee replacement presentation
DESCRIPTION
Biologic Knee Replacement (BKR) is our approach to treating knee injuries, from trauma to arthritis, and is designed to help people delay, or even avoid, artificial knee replacement. BKR is a scientifically-proven collection of our out-patient surgical techniques and procedures and consists of any combination of meniscus transplantation, articular cartilage paste grafting, ligament replacement as explained in further detail below. Being "bone on bone" does not always mean that the joint needs to be artificially replaced, often the "bone on bone" is isolated to a portion of the knee joint and this can be repaired using Biologic Knee Replacement.TRANSCRIPT
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Biologic Knee Replacement
Kevin R. Stone, MDAnn W. Walgenbach, RNNP
Wendy S. Adelson, MSJonathan R. Pelsis, MHS
Meniskus – Ersatz:Collagen Meniskus & Allograft15. Janur 2010 Stone Research Foundation
San Francisco
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The Aging Knee
Pediatric Normal Adult OA Adult
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The Knee Joint
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Meniscus
• Key shock absorber in the knee
• Torn 1.5M times annually US
• Minimal healing– No spontaneous
regeneration template
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• Loss of meniscus cartilage leads to:• Increased forces across the knee joint• Increased risk of articular cartilage damage• Pain and arthritis in many cases
• Painful arthritic joints:• Rough surfaces• Harsh, degradative environment
The Problem
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• Reduce pain and improve function
• Preserve the biology of the knee
• Restore a biomechanically favorable environment
• Provide a buffer to prevent bone-on-bone contact and pain
The Goal
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The Alignment Controversy
• Is osteotomy a two plane crude correctionof a multiplanar deformed geometry?
• Is osteotomy really a correction?
• Are the complications worth it?
“Bad biomechanics ruins good biology any day of the week…”
…However, biology lasts decades even in mechanically disadvantaged knees.
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A Solution ?Biologic Knee Replacement
1. Smooth, repair, replace, or regenerate damaged articular cartilage
2. Meniscus reconstruction
3. Meniscus allograft transplantation
Fibrous interpostional joint arthroplasty
• Reduce pain and improve function
• Increase success of cartilage grafts
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Outerbridge Grading System
For Cartilaginous Degeneration
Grade I Soft discolored superficial fibrillation
Grade II Fragmentation < 1.3 cm 2
Grade III Fragmentation > 1.3 cm 2
Grade IV Erosion to subchondral bone (eburnation)
Outerbridge RE. The etiology of chondromalacia patellae. J Bone Joint Surg Br, 1961;43: 752-7.
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Meniscus Allograft Transplantation: Indications?
Traditional thought: Meniscus Transplantation does not work in arthritic knees (Noyes & Barber-Westin 1995, Stollsteimer 2000, Rath 2001)
Current thought: Meniscus Transplantation does work in arthritic knees if damaged articular cartilage is treated as well (van Arkel 2002, Noyes 2004, Verdonk 2005, Cole 2006, Stone 2006, Farr 2007, Rue 2008)
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Sizing: Surgeon Concerns
• “It takes me 6 months to get a properly sized meniscus.”
• “My measurements do not match the bank’s measurements.”
• “Is there an easier, more accurate method for sizing?”
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Meniscus Allograft: Sizing
• Success rate may be dependant on accurate sizing
• Image-based sizing measures bony landmarks and insertion points however: • Contrast limitations
• Identification of soft versus mineralized tissue interface
• Magnification errors
Schaffer B, Kennedy S, Flimkiewicz J, Yao L. Preoperative Sizing of the Meniscal Allografts in Meniscal transplantation. Am Journal of Sports Med. Vol. 28, No. 4, 2000.
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Supporting Studies: Sizing
• 148 heights and weights compared to MRI meniscus size
Pearson’s Correlations (r):
Height vs Total Tibial Plateau (TTP) r = 0.7194
Weight vs TTP r = 0.5470
TTP vs Medial and Lateral Meniscal Width r = 0.7386, r = 0.7209
TTP vs Medial and Lateral Meniscal Length r = 0.7040, r = 0.7209
Stone KR, Freyer A, Turek T, Walgenbach AW, Wadhwa S, Crues J. Meniscal sizing based on gender, height, and weight. Arthroscopy 2007;23-5:503-8
Meniscal Sizing Based on Gender, Height, and Weight
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The Three-Tunnel TechniqueReplacing the Meniscus
Stone KR, Walgenbach AW. “Meniscal Allografting: the Three-Tunnel Technique.” Arthroscopy – The Journal of Arthroscopic and Related Surgery. 2003, 19(4):426-30.
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The Three-Tunnel Technique
Movie
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Articular Cartilage Paste Graft Procedure
Step 1
Step 5Step 4
Step 3Step 2
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Meniscus Transplantation
• 173 patients since 1997
• Clinical Exam + Patient Reported Subjective Outcome (1, 2, 3, 5, 7, 10, 15+ yrs)
• IKDC
• WOMAC
• TEGNER
The Stone Clinic Experience
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Current Study:
Long-Term Survival of Concurrent Meniscus Allograft Transplantation
and Articular Cartilage Repair: A Prospective 12-Year Follow-Up Evaluation
Pre-Allograft Allograft in placeTransplantation
OB IV
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Study Design
Study Inclusion
• Irreparable injury of the meniscus
Or
• Loss of the meniscus
– More than 50%
• OB III/IV
• ROM ≥ 90°
Study Exclusion
• Rheumatoid Arthritis
• Tri-compartment arthritis
• Total loss of joint space
• Simultaneous med/lat meniscus allograft transplantation
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Patient Selection
• Young patients with cartilage loss and pain
• Older patients with cartilage loss and focal pain who want to remain athletic and delay or avoid a knee arthroplasty.
• “Doc, isn’t there a shock absorber you can put in my knee?”
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Surgical Technique• Medial Meniscus Allograft
Transplantation: Performed utilizing periosteum, but not bone blocks, at the meniscus horns.
• Lateral Meniscus Allograft Transplantation: Preformed by preserving the bony block between the horns and inserting it into a bone trough.
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• 119 Meniscus Allograft Transplant Cases
• Mean age = 46.9 years (14.1 – 73.2 yrs)
• Mean follow-up = 5.8 years (2.1 mo – 12.3 yrs)
• 118 patients ≥ 3 months from injury to time of surgery (Mean = 14.2 years)
Patient Population
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Patient Population (N = 119)
Neutral / Varus / Valgus
Moderate ( 5 – 7°) / Severe ( > 7°)
Grade III / Grade IV
Medial / Lateral
Male / Female
None / Mild–Moderate / Severe
(Kellgren-Lawrence)
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Review of Literature
Mixed Patient Studies
N = 119
N = 100
N = 29
N = 31
N = 44
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Results
• Procedure failure: Removal of allograft without revision (N = 7), or progression to knee arthroplasty [N = 18 (TKA or UNI)].
• 94/119 allograft cases successful (79%)– Of 25 failures, Mean time-to-failure:
4.65 ± 2.99 years
– Range: 2.1 months – 10.37 years
• Kaplan-Meier estimated mean survival time was 9.93 ± 0.40 years [95%CI: 9.14,10.72]
• 13 patients were lost to follow-up
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Complications
• 4 Early Postoperative Infections– 3 Deep (1 Staphphylococcus Aures, 2 negative
serologies)– 1 Superficial (Staphylococcus Epidemis)
• All cases were treated arthroscopically with irrigation and debridement and IV antibiotics.
• All cases resolved, but one deep infection case ultimately failed, with the allograft being removed 12.5 months later.
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Subsequent Surgeries
Primary Procedure
Subsequent Surgeries
1st
N = 62
2nd
N = 21
3rd
N = 10
4th
N = 2
Meniscus Allograft Revision 2 4 1 –Meniscus Allograft Repair 12 1 2 –Meniscectomy 22 9 1 –Microfracture /Articular Cartilage Paste Grafting 4 – 1 1
Chondroplasty / Debridement 20 6 4 1Other 2 1 1 –
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Kaplan-Meier Survival AnalysisIn Patients OB III/IV
• Time-to-failure analysis with continuous enrollment over 12-yrs
• Takes into account remaining patients (still intact / lost to follow-up (N=13))
Intact/Lost To Follow-Up
94%92% 84% 79% 67%
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Cox Proportional Hazards ModelWhat is it?
• A Cox model provides an estimate of a
variable’s effect on survival after
adjustment for other explanatory
variables.
• In addition, it allows us to estimate the
hazard (or risk) of procedure failure, given
their prognostic variables.
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What factors affect survival?• Cox Proportional Hazards Model was used
to explore the relationship between procedure failure and several covariates.
Age (p = 0.026)
Number of Previous Surgeries (p = 0.006)
Number of Additional Surgeries
Osteotomy performed concomitantly
Number of concomitant procedures
Outerbridge Grade (III or IV)
Medial v. Lateral Allograft
Joint Space Narrowing
Malalignment Severity
Alignment Type
Sex
NOT RELATEDRELATED
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Cox Model - Related Hazards
• Independent of actual time-to-failure, increased number of previous surgeries (p = 0.026) and increased age at time of surgery (p = 0.006) increases the risk of meniscus allograft transplantation failure.
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Effect of Age• 53 patients over 50 (Mean = 56 yrs)
– KM mean survival = 8.84 years [95% CI: 7.51,10.17]
– 71.7% (38/53) Success Rate1 allograft removed 2 mo. post-op
14 progressed to Joint Arthroplasty @ mean 5.1 years
• 66 patients under 50 (Mean = 39 yrs)– KM mean survival = 10.67 years [95% CI: 9.76,11.58]
– 84.8% (56/66) Success Rate6 allografts removed @ mean 4.0 years
4 Progressed to Joint Arthroplasty @ mean 5.2 years
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Medial v. Lateral Allografts
Non Significant Hazard (p = 0.848)
Medial
(N = 85)
KM mean survival: 9.91 ± 0.46 years
Lateral
(N = 34)
KM mean survival:
10.17 ± 0.78 years
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Malalignment
• Severity of Mal-Alignment (p = 0.535)
– Severe Malalignment (>7º) (N = 10)
– Moderate Malalignment (5 – 7º) (N = 39)
7 Osteotomies– 71.4% Success Rate (5/7)– 2 UNI
3 NO Osteotomy– 66.7% Success Rate (2/3)– 1 UNI
– 50% Success Rate (4/8)– 2 TKA, 1 UNI, 1 Removed
8 Osteotomies– 80.6% Success Rate (25/31)– 2 TKA, 2 UNI, 2 Removed
31 NO Osteotomy
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Subjective Outcome Scores• IKDC, WOMAC, and TEGNER
questionnaire follow-up schedule was preoperatively and at 2, 3, 5, 7, 10, 15 year post-op.
• Tegner Index was used to normalize return to activity across a diverse population*
*Rodkey et al. Comparison of the collagen meniscus implant with partial meniscectomy. A prospective randomized trial. J Bone Joint Surg Am 2008;90-7:1413-26.
Current Tegner activity score
Highest reported pre-injury score= Tegner Index Score
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Subjective Outcome Scores
1.00
0.90
0.80
0.70
0.60
0.50
0.40
0.30
0.20
0.10
0.00
Mean T
egner Index S
core
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Patient Example: BK
• 27 year old male• Torn lateral meniscus in high school wrestling 1996• Partial lateral meniscectomy 2/96, 8/04
Pre-Operative X-Rays
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BK: Pre-Op MRI
• MRI documents degenerative changes to LTP and loss of lateral meniscus
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Patient Example: BK
• Lateral Meniscus Allograft Transplantation
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Patient Example: BK 8 months post
• Arthroscopy for suprapatellar pouch and anterolateral swelling
• Lateral meniscus allograft transplant had healed
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BK MRI 4 Years Post Op
•Lateral meniscus allograft appears normal and well positioned
•Patient reports no pain - “It feels really good”
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Patient Example: JL
• 35 Year Old Female
Right Knee • 1984 - Lateral
Meniscectomy• 1988 - Lateral release• 2003 - Knee locked, total
meniscectomy• Valgus Alignment
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Patient Example: JL
OB III/IV far-posterior aspect LFC, Microfracture LFC
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JL: 4 months Post-Op
• Flexion contracture, debridement, closed manipulation, notchplasty
• No evidence of meniscal impingement
• Healed, intact lateral meniscus
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JL: 6 years Post-Op
• Lateral Meniscus repair, chondroplasty, debridement, notchplasty
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Patient Example: JA
• 37 Year old female
• Meniscectomy at age 20
• R-Lateral Meniscus missing
• OB III chondral defect
• Microfracture, Chondroplasty LFC
Long-Leg AP
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JA: Preoperative X-ray
LateralAP
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JA: Preoperative MRI
Lateral meniscus:• Absent posterior horn
Articular Cartilage:• Chondral damage
to LFC
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JA Operative Images
A B CDeficient Lateral
MeniscusChondral Lesion of
LFCMicrofracture of
Lesion
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JA Operative Images
A B CAbsent Meniscus Lateral Meniscus
AllograftAllograft
Placement
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JA: 5 Months Post-Op
Full ROM with smooth articulation
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JA: 2Yr Postoperative X-ray
PA Flexion AP
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JA: 2yr Post-operative MRI
• Healed lateral meniscal allograft
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JA: 5Yr Postoperative X-Ray
PA Flexion AP
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JA: 5Yr Postoperative MRI
• Virtually unchanged meniscal allograft
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Patient Example: GC
7o varus L-knee
Medial joint space narrowing
Active 53 y.o. male.
Meniscectomy: 1986, 1996
Medial meniscus-allograft 3/99
Paste Graft MFC & MTP
High medial tibial osteotomy (Bionx wedge and allograft bone)
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GC: Preoperative Images
Sagittal MRI
Loss of cartilage MFC
PA Flexion
Medial joint space narrowing
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GC: Operative Images
A BBipolar lesions Morselization of MFC & MTP
Loss of medial meniscus
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GC: Operative Images
A B CPlacement of medial
meniscal allograftImpaction ofpaste graft
Paste GraftedLesion
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GC: Postoperative X-Ray
Long-leg AP
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GC: 3Yr Postoperative X-ray
APLong-leg
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GC: 3Yr Postoperative Images
3 Years post-op L-medial allograft, osteotomy, & paste graft
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GC: Comparison of healing
3-Years post-op allograft and paste graft to MFC
Operative 3 yrs Post-op 3 yrs Post-op
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Patient Example: SC
• 39 y.o. male• Injury: 1970s playing hockey
• Meniscectomy (1999)
• Pre-op: • Varus • Joint space narrowing
• Right Medial Meniscus Allograft (2000)
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SC: Preoperative MRI
Bucket-handle tear with bipolar cartilage lesions on MFC & MTP
Coronal Sagittal
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SC: Operative Images
Right knee bucket-handle tear displaced into intercondylar notchA B
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Eburnated bone MFC Eburnated bone MTP
Microfracture MTP Microfracture MTP
SC: Operative Images
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SC: Placement of Allograft
Right Knee Placement of Medial Meniscal Allograft
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SC: Comparison of healing
Return to full activity
Intermittent catching and pain
17 Mo Post-opPre-op
Note improved joint space compared to pre-op
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SC: 17 Mo Post Op MRI
Coronal Sagittal
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SC: 2nd Surgery
Movie 17 mo. Post Paste graft MFC + Meniscus Allograft
Initial Surgery 17 mo. Post-opMeniscectomy
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SC: 5 yr Post Op Images
AP
Allograft present with maturing degenerative changes
Coronal
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Patient Example DB
• 47 YO Male Skier
• R Knee: Chronic Pain
• Moderate to Severe Bilateral Pain
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DB: Right Knee
Right Knee:
• 09/91: Medial Meniscectomy, Drilling MFC, Chondroplasty
• 12/97: (triple) Medial Meniscus Allograft, Osteotomy, Art Cart MFC, MFx LFC
• 05/98: Revision Osteotomy, Medial Meniscectomy, Debridement, MFx MTP
• 10/2000: Ilizarov, Meniscectomy, ChondroplastyPre-Op XRAY
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DB: Right Knee 10 Yr PostOp MRI
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DB: 10 Yr Post Op XRAY
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DB: 10 Yr PostOp
63 YO, Tegner = 6, Skis 30+ days/yr, Snow skis 50+ days/yr.
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• 47 YO Female
• Beach volleyball injury (11/03)
• Failed debridement (11/03)
• Clinical exam:– Pain at rest = 8/10– Severe swelling – Giving way
• Meniscus Allograft, ACL reconstruction, Chondroplasty (3/05)
Patient Example: RT
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RT: Pre-Operative MRI
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Torn medial meniscus
MFC chondral lesion
LFC chondral lesion Torn ACL
Patient Example: RT
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Medial meniscus Allograft Allograft Insertion
Allograft placement ACL BTB allograft
Patient Example: RT
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• Intact meniscus allograft• ACL hardware removal due to prominence of fixation screw
RT: 3 Months Post
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Excellent joint space, intact meniscus allograft and ACL, but right knee clicking and catching
RT: 18 Months Post
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Intact meniscus allograft and ACL with diffuse thinning of patellofemoral cartilage
RT: 18 Months Post
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• Surgery for catching due to chondral flap at patellofemoral joint
• Intact meniscus allograft and ACL
RT: 18 Months Post
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Patient Example: RM57 Male
Long-leg MRI
• Injury: Football tackle 1978 • Previous Meniscectomy: 1978, 1993• Moderate varus mal alignment (≤ 7°)• MFC OCD lesion
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RM: Operative Images
Severe Articular Cartilage Damage
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RM: Operative Images
Allograft insertionArticular Cartilage
Paste Grafting Repair
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RM: Operative Images
High tibial opening wedge osteotomy
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RM: 3.5 Years Post-Allograft
Movie
Primary Surgery Second Look, 3.5 years later
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RM: Histology
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RM: 3.5 Years Post Operative
Long-leg
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RM: 5 Years Post Operative MRI
SagittalCoronal
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RM: 6 Year Post Operative X-Ray
Long-leg
Lateral
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Patient Example: HM
5-7o varus L-knee
• 18 Yrs Post meniscectomy
• 2 Meniscectomies (‘86, ’96)
• Pain >1 year
• Varus deformity
• Medial joint space narrowing
• L-medial meniscus-allograft (3/1999)
• Paste graft MFC & MTP
• High medial tibial osteotomy (Bionx wedge and allograft bone)
• Chondroplasty LFC
• Partial lateral meniscectomy
• Notchplasty
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HM
4 Yrs 9 Mo Post Paste Graft
Debrided lesion Healed paste graft
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HM
4 Yrs 9 Mo Post Paste Graft
Biopsy Histology
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Biologic Knee Replacement Revision Surgery
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Patient Example: TA• 48 y.o. world-class female marathoner
• 86 marathons, • 12 Ironmans• 3 Double Ironman Triathalons
• Neutral alignment / mild medial joint space narrowing
• Meniscectomy: 4/2001 and 1/2002
AP X-ray
•R Medial Meniscus Allograft + Microfracture (bipolar lesions)
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TA: Preoperative MRI
• Tear at horn of medial meniscus• Osteoarthritis: medial compartment
SaggitalCoronal
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4/22/02: Right medial meniscus rim before allograft
TA: Operative Images
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TA: Meniscus Allograft Placement
A B MoviePreparation of medial
meniscal allograftPlacement of medial
meniscal allograftRelationship of lesion
to meniscus
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TA: Injury
C
• Injury: 2 Mo. Post-op
• Swam in pool for 2 hours
• Developed immediate swelling
A Movie
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TA: Revision
CA
Movie
Revision: 8 Months Post-allograft
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TA: Revision: Operative Images
Insertion of Meniscus Allograft with Articular Cartilage Paste Grafting
Joint Arthroplasty 3/2006 (38 Mo. Post Op)
A B C
D
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Patient Example: RT
• 34 YO male
• Partial meniscectomy for torn lateral meniscus (9/91), debridement 2006
• Lateral joint line pain
• Severe pain and swelling with activities
• Positive Apley’s, McMurray’s, and hyperextension tests
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RT: Pre-Op Imaging
• X-rays: Collapse of lateral joint space. Mild patellar spurring.
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RT: Pre-Op MRI
• Loss of articular cartilage on posterior aspect of LFC• Loss of posterior and central aspects of lateral meniscus
PD SAG PD COR
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RT: Surgery 11/2009
• Lateral Meniscus Allograft transplantation
• Microfracture LFC and LTP (too far posterior for Articular Cartilage Paste Grafting)
• Removal of anvil osteophyte
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RT: MRI 2 days Post Op
• Allograft intact without evidence of tear• Anterior subluxation of the posterior aspect of the
lateral meniscus with anterior displacement of the bone block (12 mm).
FSE T2 SAG FSE PD SAG
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RT: Revision Surgery
• Interval repositioning of the lateralmeniscus 5 days post index procedure.
• Re-microfracture of distal femoral condyleto ensure good blood clot.
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RT: MRI 1 Day Post Revision
• Repositioned Lateral Meniscus Allograft
FSE T2 SAG FSE PD SAG
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Conclusions• Our research represents the largest and
longest prospective study of meniscus replacement patients with severe chondral damage.
• Meniscus replacement can improve symptoms, even in severe OA.
• Meniscus replacement should not be limited to young patients without articular cartilage damage.
• Axial malalignment does not affect outcome.
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Conclusions
• Height and weight can be used to size meniscal allograft tissue.
• Three-tunnel Technique is necessary to fix meniscus allograft to tibial plateau, not the surrounding tissue, to avoid meniscus subluxation
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Conclusions
• Repair of severe articular cartilage damage combined with meniscus replacement provides significant improvements in activity, pain, and function.
• Improvements are maintained over the course of follow-up (2 – 12 yrs).
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Conclusions • The number of TKA surgeries is predicted to
increase to 3.4 million by 2030*, with increasing costs†.
• 18/119(15%) cases in our study progressed to knee arthroplasty 4.8 years after meniscus replacement (range: 1.3 – 10.4 yrs).
• Average age at time of knee arthroplasty was 61 years (range: 52 – 72 yrs).
*Kurtz, AAOS Chicago, 2006†Kurtz, JBJS, 2007
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Conclusions
• Biologic joint reconstruction, rather than bionic (artificial) replacement, may be an appropriate first step for many people with knee joint arthritis.
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Acknowledgements
• Thomas Turek
• Mark Coleman
• Abhi Freyer
• Ann Walgenbach
• Jonathan Pelsis
• Wendy Adelson
• Sharon Bobrow
Meniscus Allograft Transplantation: 1997 – 2010
Articular Cartilage Paste Grafting: 1991 – 2010
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2009 Team
2005 Team