analysis of a knotless flexor tendon repair...

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Analysis of a Knotless Flexor Tendon Repair Using a Multifilament Stainless Steel Cable-Crimp System Leonard Gordon, MD,Jun Matsui, MD, Erik McDonald, BS,Joshua A. Gordon, MD, Ronald Neimkin, MD Purpose To compare the biomechanical and technical properties of flexor tendon repairs using a 4-strand cruciate FiberWire (FW) repair and a 2-strand multifilament stainless steel (MFSS) single cross-lock cable-crimp system. Methods Eight tests were conducted for each type of repair using cadaver hand flexor digitorum profundus tendons. We measured the required surgical exposure, repair time, and force of flexion (friction) with a custom motor system with an inline load cell and measured ultimate tensile strength (UTS) and 2-mm gap force on a servo-hydraulic testing machine. Results Repair time averaged less than 7 minutes for the 2-strand MFSS cable crimp repairs and 12 minutes for the FW repairs. The FW repair was performed with 2 cm of exposure and removal of the C-l and A-3 pulleys. The C-l and A-3 pulleys were retained in each of the MFSS cable crimp repairs with less than 1 cm of exposure. Following the FW repair, the average increase in friction was 89Vo compared with an average of 53Vo for the MFSS repairs. Six of the 8 MFSS specimens achieved the UTS before any gap had occurred, whereas all of the FW repairs had more than 2 mm of gap before the UTS, indicating that the MFSS was a stiffer repair. The average UTS appeared similar for both groups. (onclusions We describe a 2-strand multifilament stainless steel single cross-lock cable crimp flexor repair system. In our studies of this cable crimp system, we found that surgical exposure, average repair times, and friction were reduced compared to the traditional 4-strand cruciate FW repair. While demonstrating these benefits, the crimp repair also produced a stiff construct and high UTS and Z-mm gap force. (linical relevance A cable crimp flexor tendon repair may offer an attractive alternative to current repair methods. The benefits may be important especially for flexor tendon repair in zone 2 or for the repair of multiple tendons. (J Hand Surg 2013;38A:677-683. Copyright @ 2013 by the American Societyfor Surgery of the Hand. All rights reserved.) Key words Biomechanics, crimp, flexor tendon, stainless steel, suture. ESIITE MANv RECENT improvements in the bio- mechanical parameters of repair technique and sutures, there are still challenges facing sur- geons who perform flexor tendon repairs.r-lo An opti- mal tendon repair should be simple to perform and hlm tlre Deplft nent 0f Anotony oil 1rthopaedk Swyy, Univasity of Colifunio, kn honckqSon hancivo,A. Received for publication Augun 15, 2012; accepted in revised form January 7, 201 3. Ihe authon ttunk Blane Uthrnan for his invaluabh technical supprt during the entire testing and expedmental process. Funding for this research was provided by Pontis 0rthopaedi6. LG. owns stod in Pontis orth0pae- dicr J.G.'rs an imnrdiate family mmberof LG. provide accurate coaptation of the tendon ends. The repair should also provide strength for early active range of motion,l1-16 stiffness to resist gap formation during rehabilitation,tl-2o ^6 compactness for smooth gliding through the pulley system. There has been little (onepondng author Leonard Cordon, MD, Departrnent of Anatomy and Orthopaedk Surgery, University of California, San Frantisto,299 Post Street $n francisco, G 9115; email: [email protected]. 0363-s023/1 3/38A0+m07536.m/0 httpJ/dx.doi.0rg/10.1016{ jhsa.201 1.01.0'l 8 @ zor3 ASSH . Published by Elsevier, Inc. A11 rights reserved. . 677

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Page 1: Analysis of a Knotless Flexor Tendon Repair Usingpontisorthopaedics.com/pontis/wp-content/uploads/... · tendon. The tendon was then loaded in uniaxial ten-sion at I mm/sec until

Analysis of a Knotless Flexor Tendon Repair Using aMultifilament Stainless Steel Cable-Crimp System

Leonard Gordon, MD,Jun Matsui, MD, Erik McDonald, BS,Joshua A. Gordon, MD, Ronald Neimkin, MD

Purpose To compare the biomechanical and technical properties of flexor tendon repairsusing a 4-strand cruciate FiberWire (FW) repair and a 2-strand multifilament stainless steel(MFSS) single cross-lock cable-crimp system.

Methods Eight tests were conducted for each type of repair using cadaver hand flexordigitorum profundus tendons. We measured the required surgical exposure, repair time, andforce of flexion (friction) with a custom motor system with an inline load cell and measuredultimate tensile strength (UTS) and 2-mm gap force on a servo-hydraulic testing machine.

Results Repair time averaged less than 7 minutes for the 2-strand MFSS cable crimp repairsand 12 minutes for the FW repairs. The FW repair was performed with 2 cm of exposure andremoval of the C-l and A-3 pulleys. The C-l and A-3 pulleys were retained in each of theMFSS cable crimp repairs with less than 1 cm of exposure. Following the FW repair, theaverage increase in friction was 89Vo compared with an average of 53Vo for the MFSSrepairs. Six of the 8 MFSS specimens achieved the UTS before any gap had occurred,whereas all of the FW repairs had more than 2 mm of gap before the UTS, indicating thatthe MFSS was a stiffer repair. The average UTS appeared similar for both groups.

(onclusions We describe a 2-strand multifilament stainless steel single cross-lock cable crimpflexor repair system. In our studies of this cable crimp system, we found that surgicalexposure, average repair times, and friction were reduced compared to the traditional4-strand cruciate FW repair. While demonstrating these benefits, the crimp repair alsoproduced a stiff construct and high UTS and Z-mm gap force.(linical relevance A cable crimp flexor tendon repair may offer an attractive alternative tocurrent repair methods. The benefits may be important especially for flexor tendon repair inzone 2 or for the repair of multiple tendons. (J Hand Surg 2013;38A:677-683. Copyright@ 2013 by the American Societyfor Surgery of the Hand. All rights reserved.)

Key words Biomechanics, crimp, flexor tendon, stainless steel, suture.

ESIITE MANv RECENT improvements in the bio-mechanical parameters of repair technique andsutures, there are still challenges facing sur-

geons who perform flexor tendon repairs.r-lo An opti-mal tendon repair should be simple to perform and

hlm tlre Deplft nent 0f Anotony oil 1rthopaedk Swyy, Univasity of Colifunio, kn honckqSon

hancivo,A.

Received for publication Augun 15, 2012; accepted in revised form January 7, 201 3.

Ihe authon ttunk Blane Uthrnan for his invaluabh technical supprt during the entire testing and

expedmental process.

Funding for this research was provided by Pontis 0rthopaedi6. LG. owns stod in Pontis orth0pae-

dicr J.G.'rs an imnrdiate family mmberof LG.

provide accurate coaptation of the tendon ends. Therepair should also provide strength for early activerange of motion,l1-16 stiffness to resist gap formationduring rehabilitation,tl-2o ^6 compactness for smoothgliding through the pulley system. There has been little

(onepondng author Leonard Cordon, MD, Departrnent of Anatomy and Orthopaedk Surgery,

University of California, San Frantisto,299 Post Street $n francisco, G 9115; email:

[email protected].

0363-s023/1 3/38A0+m07536.m/0httpJ/dx.doi.0rg/10.1016{ jhsa.201 1.01.0'l 8

@ zor3 ASSH . Published by Elsevier, Inc. A11 rights reserved. . 677

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678 ANALYSIS OF A KNOTLESS FLEXOR TENDON REPAIR

1

2

3

45

6

7

8

9

AverageStandard deviation

Pull through tendon

Pull through tendon

Pull through tendon

Pull through tendon

Pull through tendon

Pull through tendonSuture brokeSuture brokeSuture broke

Sample Number uTs (N) Failure Mechanism

which is the strongest repair reported in the litera-ntre.23-27 The goal of this study was to analyze whetherthe cable crimp method would have technical advan-tages ofreduced repairtime, less surgical exposure, andlow force of flexion (friction) while still producing astrong repair with high ultimate tensile strength GnS)and 2-mm gap force.

MATERIALS AND METHODSWe compared the parameters of the MFSS cable-crimprepair with a 4-strand cruciate FW repair. We measuredthe force of flexion of the intact tendon and then mea-sured the force of flexion following repair. The percentchange in this force was then calculated. We also mea-sured the ultimate load and load at z-mm gap,"'"ttwhich likely conelates with clinical performance.r'r6We measured the time for the tendon repair and mea-sured the length of surgical exposure needed.

Force offlexion (friction), ultinrate tensile strength, and2-mm gap force

Flexor digitorum profundus tendons were used in theindex, middle, and ring fingers of cadaver hands, with 8samples in 2 groups. The force of flexion was deter-mined by mounting the hands to plastic boards usingSteinmann pins that were drilled through the radius andulna. The skin was removed from the palmar surface ofthe finger and palm from the distal inteqphalangealjointcrease to the mid palmarcrease, leaving the tendons andthe entire pulley system intact. The flexor digitorumprofundus tendons were then dissected and separated atthe wrist. Each tendon was connected to a custommotor system that flexed the finger though a repeatableexcursion 50 times. To measure and record the forceneeded for full excursion of the tendon, an inline loadcell was connected between the tendon and the motor.We marked a point on the tendon I cm distal to the A2pulley and initially measured the baseline force requiredfor this point on the tendon to travel to a point proximalto the A1 pulley. To extend the finger, a suture waspassed through the nail ofeach finger and connected toa 100-9 weight that was hung over the end of the board.

Each tendon was transected I cm distal to the A2pulley and then repaired.

Group 1 received a 4-strand, cruciate repair, using3-0 FW with a knot consisting of 5 throws, and group2 received a 2-strand, single cross-lock cable-crimprepair, using 4-0 MFSS (double suture).

For the MFSS cable-crimp repairs, we used MFSSwith a specifically designed stainless steel crimp that wehave previously described.e'22 For the MFSS crimprepairs, we used a single cross-locked repair configura-

90

il9llt12493

89

126ll0t07r08

14

Suture size, 3-0, 0.012 in i0.3083 mm).xMeasured on a servo-hydraulic testing machine (Mini-Bionix

858: MTS). This cross-lock was used for group 2.

discussion about the technical difficulty and complexityof performing these repairs that require 4 or 6lockingconfigurations. In addition, surgical exposure and thedifficulty in attaining exact tensioning and coaptation oftendon ends without gap or overlap are important con-siderations. Many biomechanical properties of repairtechnique have been studied and include suture caliber,strength, stiffness, number of strands, method of attach-ment, and distance of the suture from the tendon'stransected end. Other important considerations includestrength and stiffness of the knot and friction of therepair with excursion through the flexor tendon sheath.These properties are all interdependent, and a systemthat addresses all of these parameters simultaneously isrequired.

A multitude of techniques exist for attaching suturesto tendon.2l Our prior studies found the strongest at-tachment to be this single cross-lock (Table 1). We useda 3-0 multifilament stainless steel (MFSS) cable, astainless steel crimp, and a single cross-lock affachmentto the tendon to achieve a favorable combination ofbiomechanical parameters for a 2-strand repair of flexordigitorum profundus tendons in cadaver hands.

We have previously reporled on the biomechanicalparameters of MFSS suture22 and stainless steelcrimps.e ln this study, we investigated the performanceof this repair construct in cadaver tendon repairs andcompared the biomechanical properties with a Fiber-Wire (FW) (Arthrex, Naples, Florida) cruciate repair,

JHS.Vol 38A, April zor3

TABLE 1. Strength and Mode of Failure ofMFSS Attached to a Cadaver Flexor DigitorumProfundus Tendon by a Single Cross-Lock StitchStarting 1.2 cm From the Cut Tendon End*

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ANALYSIS OF A KNOTLESS FLEXOR TENDON REPAIR

FIGURE 1: A 4-strand cruciate 3-0 FW repair was performed1 cm distal to the A2 pulley, followed by a running 5-0 nylonepitendinous stitch.

tion attached to each side of the divided tendon. Inpreliminary testing on a servo-hydraulic testing ma-chine (Mini-Bionix 858; MTS, Eden Prairie,IVIN), thestrength of multiple repair configurations for tendonattachment was measured and the single cross-lock wasfound to be the strongest (Table l).

Following the cable crimp repair, the Cl and A3finger pulleys were removed to make the groups equalfor measurement of the force of flexion. The hand wasthen returned to the testing machine, and the force offlexion test was repeated, using the same excursion asthe baseline testing. The change in the force of flexionwas compared to the baseline measurements for eachgroup. The tendons were then removed from the handso the ultimate load and load at 2-mm gap could bemeasured.

Each tendon repair was loaded in uniaxial tensionusing the standard protocol of our laboratory.22 Briefly,the repaired tendon was loaded onto a servo-hydraulictesting machine Mini-Bionix 858; MTS) and subjected to10 slow cycles from 5 to 10 N to pretension thetendon. The tendon was then loaded in uniaxial ten-sion at I mm/sec until failure. Video of the test wasanalyzed frame by frame to determine the maximumforce before 2 mm of gapping.

5urgical method

Standard 4-strand cruciate repairs using 3-0 FW and arunning nonlocking epitendinous stitch using 5-0monofilament nylon were performed on the 8 tendonsin group 1. Removal of Cl and ,A.3 provided the re-quired exposure for the repair (Fig. l).zz-zt

The cable crimp repairs on the 8 tendons in group 2were performed with a 3-0 MFSS suture (Fig. 2).lni-tially, the suture was attached to the tendon on each side

GRoUP 1

GRoUP 2

-;-FIGURE 2: Group l: a 4-strand cruciate repair using 4-0 FWwith a knot. Group 2: single crossJock 2-strand cable crimprepair using single-strand 3-0 MFSS. (Suture starts 1.2 cmfrom the cut end).

of the laceration, using a single cross-lock stitch. Thesuture was flrst passed across the tendon at a right angleto the long axis 1.2 cm from the cut end. A second passwas made 0.6 cm from the cut end, also at right angles,to create a large single cross-lock attachment. The su-ture ends were then passed out the cut end with a simplegliding stitch. Each side was attached separately, andthis required 1.2 cm of exposed tendon brought into thewound one at a time but not simultaneously. The distaltendon was presented by flexing the interphalangealjoints to expose this length of tendon. The cross-lockwas then allowed to retract within the pulley on both theproximal and distal sides. Both ends of the cut tendonwere not brought together until the time of crimping.The needles were cut off from the suture ends, and acrimp holder was used to bring a crimp into the repairsite. The sutures were passed through the lumen of thecrimp from each end (Fig. 3). The sutures were pulledtight to ensure a secure cross-lock attachment to thetendon. Traction from both sides was then applied toapproximate the tendon ends to exactly the tensionneeded to provide optimal coaptation without overlapor gap. At this point, a single epitendinous stitch using5-0 nylon was used on the radial or ulnar side of therepair to ensure exact rotation. A calibrated crimp toolwas introduced from the side of the repair opposite tothis stitch and used to compress the crimp, therebyflxing the sutures from each side together. Two addi-tional simple intemrpted epitendinous stitches of 5-0monofilament nylon were placed on the palmar surface

JHS.Vol 38A, April zor3

679

/.6cM

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680 ANALYSIS OF A KNOTLESS FLEXOR TENDON REPAIR

FIGURE 3: A Multifilament stainless steel sutures from each end of the divided tendon are brought through a crimp (held by a

crimp holder). B The crimp is shown containing cables from each side of the divided tendon. C A calibrated crimp tool is used tocompress the crimp and connect the sutures. D The completed crimp repair is covered with simple intemrpted epitendinousstitches. The A2, C1, and A,3 pulleys are intact, and the repair occurs in less than I cm between the Cl and ,{3 pulleys.

of the tendon to bury the crimp within the tendon repairsite.

Repair timeEight repairs each were completed for the FW repairand the MFSS single cross-lock cable crimp repair. Werecorded the time for each of these 16 repairs. Thetendon ends were prepared for repair, and time wasmeasured from the start of the repair until the finalepitendinous stitch was tied. The time for surgical ex-posure, preparation of the tendon, and skin closure wasnot included.

Surgical exposure

The distance needed to complete the repair in eachgrcup was recorded. The FW repair required removal ofthe C-l and A-3 pulleys. Pulleys were left intact for theMFSS repair, and suture connection was completedbetween the pulleys.

Statistical analysis

Data for the UTS, maximum load before 2 mm ofgapping, and percent change in friction from baseline

were compared between the 2 groups using a httann―

Whitney U test with signincance set at P<.05.

RESULTS

Repairtime

me repair time for tendon repairs averaged 12 11mutes

for the 4-strand cruciate FW “

palr and less than 7

rllmutes for the 2-strand MFSS cable c五 mp repair.

Surgicai exposure

ne surgiCal exposure for the FW repalr averaged 2.1

cln.The average exposure for the WSS was O.6 cln.

All FⅣ  repalrs required rewction ofCl and A3 pumeys.

Pulleys were retamed in d1 2-strand NIFSS repars.

Force offlexion′ 暖:timate tensile strength′ and 2-m鵬靡gap

for(e

The force of flcxlon lnettured 89 ± 359ろ and 53 ±

18%for the 4-strand cnlciate FW repair and 2-strand

MFSS cable c五 mp repair,respecively C=.007).In 6

of the 8 tests usng the 2-strand MFSS cable c― p

repalr,the 2- rllm gap occuttd after con3 suture failure,

JHS.Vol 38A, April zor3

:〆

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ANALYSIS OF A KNOTLESS FLEXOR TENDON REPAIR ‘0

demonstrating the stiffness of the repair. The 2-strandMFSS cable crimp repairs were stiffer than the FWcruciate repairs. Six of the 8 MFSS specimens achievedthe UTS before any gap had occurred, whereas all ofthe 4-strand cruciate FW specimens had more than 2mm of gap before the UTS. This difference was statis-tically significant (Fisher's exact test, P : .007). With8 specimens in each group, there were no statisticallysignificant differences in the ultimate load between the2 groups.

All MFSS repairs failed by suture breakage, with thecross-lock remaining secure in the tendon at the point offailure. Five of the FW repairs failed by suture pulloutfrom the tendon and 3 by knot failure.

DrscussloNDespite advances in flexor tendon repair and identifi-cation of factors that affect the outcome of these repairs,there remains a need for a repair that is simple and fastand results in a strong, stiff construcl6'8'36 In this study,we report on a 2-strand cable crimp repair with a 3-0MFSS cable that satisfies these criteria. This repair usesa single cross-lock stitch, requires minimal surgicalexposure, and requires approximately half the surgicaltime to complete the repair when compared to a4-strand cruciate FW repair.

Use of a crimp in tendon repair has several benefits.Each end of the tendon can have the suture insertedindependently and then brought together for the tendonrepair. This means that both sides of the repair do notneed to be exposed simultaneously, and therefore theneed for surgical exposure is reduced, usually to lessthan I cm. This decreases exposure to a mini-incisionthat we have described previously.s5 Using a crimpenables tensioning of the tendon ends as they are ap-proximated, avoiding excessive bunching, yet with ex-act tendon contact. The repair described requires only 2strands and 1 cross-lock with limited tendon handling.This may be beneficial for situations in which multipletendons need to be repaired.

Previous reports have investigated the suitability ofstainless steel as a material for tendon repairs.2'37'38Monofilament stainless steel was widely used at onetime. Despite its strength, it lost favor because it is stiff.Monofilament stainless steel kinks readily, whichmakes it difficult to handle. The MFSS cable used in thepresent study is pliable and handles easily, like a poly-mer suture. Crimping has previously been described inother areas of orthopedic surgery, but with much largerconstructs such as the greater trochanter with the Dall-Miles cable grip system (Stryker, Kalamazoo, I\rtI)."We have previously reported on MFSS cable, which

has an ultimate tensile strength more than twice that ofFW, with half the elongation at the point of failure. 22

We have also previously reported on the use of a crimpto connect sutures that we found to be stiffer andstronger than a knot.e We have combined this cable andcrimp with a firm attachment of suture to the tendonthat we developed in preliminary testing. With thiscombination, we were able to produce a strong and stifftendon repair with both a high UTS and a high 2-mmgap force. This gap formation of 2 to 3 mm after tendonrepair has been shown to decrease mechanical perfor-mance and may indicate that the tendon repair has beenloaded beyond its ultimate failure point.la're'35'oo St or-ger suture material with a higher caliber has beenshown to decrease gap formation.2s'2e'37'41 The extrastrength from a higher-caliber suture and increasednumber of strands3r'al is reported to increase the UTSand 2-mm gap force,8'l3"te'28'2e'42 but this must bebalanced with the additional bulk and resistance togliding that it brings to the repair.36 The increasedfriction in the FW cruciate repairs compared with thecable crimp repair may result from the epitendinousstitching or the bulk of the knot, considering that FWrequires 5 throws to resist untying. The stiffness of therepar, and therefore the ability to resist 2-mm gap, wasdemonstrated by the finding that in 6 of 8 of the repairsusing the 2-strand cable crimp with 3-0 MFSS, the coresuture broke before the 2-mm gap was reached.

Stronger and higher-caliber suture materials may in-crease repair strength, but they also increase the possi-bility that the repair will fail by suture pullout from thetendon. Earlier tests investigated strength and friction inconfigurations of suture attachment to tendon. We ulti-mately selected the single cross-lock, which providedthe optimal combination of high strength and low forceof flexion. For the control repair, we chose a 4-strandcruciate FW suture repair, as this is reported to be thestrongest repair in several studies. I 7'23'37'43'44

The knot has been identified as the area of thesuture that is weakest.e'2o'23'32'43'4s If the sutureattachrnent to the tendon is stronger than the suture andknot complex, the repair will fail by suture breakageat the knot.42'46 ln the repairs using FW, we foundthat repair failure occurred by suture pullout or bybreakage at the knot. Even though the crimp is stron-ger than a knot, all of the cable crimp repairs failedat the crimp. This raises the potential for furtherstrength of the repair with added engineering of thecrimp, such as smoother edges to avoid suture breakage.

Epitendinous sutures have been used to increaseUTS in other repairs,''o'6'8 but we found this unneces-sary, as we achieved sufficient strength and excellent

JHS.Vol 38A, April zor3

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582 ANALYSIS OF A KNOTLESS FLEXOR TENDON REPAIR

coaptation with the core stitch. We used 2 or 3 inter-rupted epitendinous stitches on the palmar surface ofthe tendon to bury the crimp within the repair site. Noepitendinous stitches were needed on the dorsal surface,as this was found to be well aligned, thereby reducinginterference with the vincular system and simplifyingthe repair.

Damage to the tendon and interference with vascu-larity is difficult to assess. The primary vascular supplyto the tendon in zone 2 enters from the vinculae, whichapproach the dorsal aspect of the tendon. Other nutritionalcontributions come from surface vessels and boneattachments ,47-4e as well as the synovial fluid.so-s2A repair placed in the dorsal part of the tendon mayhave greater tensile strength when locking sutures areur.6s3'sa but may interfere with the vincular supply.soAlthough the repair method described placed thecross-lock in the palmar half of the tendon so as notto interfere with the dorsal circulation, it achievedgood UTS and 2-mm gap force.

Additional studies concerning healing and use ofMFSS cable crimp systems in the clinical setting areneeded to further define their role in tendon repair.

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