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BY
T HE J OURNAL
OF
B ONE
AND J OINT
S URGERY, I NCORPORATED
Background: This prospective randomized trial with a mean fourteen-year follow-up compared simple end-to-end repair
with fascial ap-augmented repair for acute Achilles tendon ruptures.
Methods: From 1998 to 2001, sixty patients with acute Achilles tendon rupture were randomized to receive simple endto-end repair or augmented repair; both groups were treated with postoperative bracing allowing free active plantar exion.
After a follow-up of thirteen years or more, fty-ve patients (twenty-eight in the nonaugmented-repair group and twentyseven in the augmented-repair group) were reexamined. Outcome measures included the Leppilahti Achilles tendon score,
isokinetic plantar exion strength (peak torque and the work-displacement decit at 10 intervals over the ankle range of
motion), tendon elongation, and the RAND 36-item health survey.
Results: After a mean of fourteen years of follow-up, the mean Leppilahti score was 87.1 points for the nonaugmented repairs
and 91.5 points for the augmented repairs, with a mean difference of 4.3 points (95% condence interval [CI], 20.1 to 8.8
points). The surgical technique did not have an impact on strength parameters, with a mean peak torque of 112.6 Nm after the
nonaugmented repairs and 107.3 Nm after the augmented repairs (mean difference, 5.3 Nm [95% CI, 222.2 to 11.6 Nm]) and
a median work-displacement decit of 6.7% to 20.3% after the nonaugmented repairs and 12.8% to 18.0% after the augmented repairs (p = 0.9). Strength did not signicantly change between the twelve-month and fourteen-year follow-up examinations. At a mean of fourteen years, the injured side showed a 12.2% to 18.0% median work-displacement decit compared
with the unaffected side (p < 0.001). RAND-36 scores indicated no between-group difference in health domains.
Conclusions: Augmented repair of total Achilles tendon ruptures provided no advantage over simple end-to-end repair.
Achilles tendon ruptures result in a permanent calf muscle strength decit, but its clinical relevance remains unclear.
Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Peer review: This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewed
by an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a nal review by the Editor-in-Chief prior to publication.
Final corrections and clarications occurred during one or more exchanges between the author(s) and copyeditors.
Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any
aspect of this work. None of the authors, or their institution(s), have had any nancial relationship, in the thirty-six months prior to submission of this work,
with any entity in the biomedical arena that could be perceived to inuence or have the potential to inuence what is written in this work. Also, no author has
had any other relationships, or has engaged in any other activities, that could be perceived to inuence or have the potential to inuence what is written in this
work. The complete Disclosures of Potential Conicts of Interest submitted by authors are always provided with the online version of the article.
http://dx.doi.org/10.2106/JBJS.O.00496
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tion, which leads to muscle atrophy. The immobilizationinduced strength decit decreases for up to a year, but it remains
uncertain whether there is continued improvement in other
aspects of function and symptoms. Olsson et al. found only
minor improvements in plantar exion strength of the ankle
between one and two-year follow-up examinations1. There are
few reports of long-term results of Achilles tendon rupture, and it
is unclear how to optimize treatment to avoid possible long-term
decits.
The aim of the present prospective, randomized, clinical
study was to compare the long-term results of augmented and
nonaugmented surgical repairs of total Achilles tendon ruptures in patients treated with identical postoperative rehabilitation protocols. Our secondary goal was to assess whether the
strength decit of the injured leg reported in our previous
study4 had resolved at the time of long-term follow-up.
Fig. 1
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Men/women (no.)
Mean age (SD) (yr)
P Value
24/4
24/3
0.73
39 (9)
38 (7)
0.84
0.9
Competitive athlete
Recreational athlete
Nonathlete
24
3
24
2
25 (2.6)
his study was a long-term follow-up of a previously published, prospective, randomized, controlled trial comparing augmented with nonaugmented
4
surgical repair of Achilles tendon ruptures . The local research ethics committee
approved the original trial protocol and our reexamination of the patients. The study
was registered at ClinicalTrials.gov (NCT02018224). All patients received oral and
written information about the trial and provided informed consent to participate.
The inclusion criterion was a complete acute Achilles tendon tear in a patient
eighteen to sixty-ve years of age. The exclusion criteria were a delay of more than
one week between the rupture and treatment, local corticosteroid injection(s)
around the Achilles tendon within six months before the rupture, previous Achilles
tendon rupture on the contralateral side, open Achilles tendon rupture, skin
problems over the Achilles tendon area, living outside Finland, and diabetes mellitus.
Between October 1998 and January 2001, eighty-three patients were
screened for trial eligibility at a university teaching hospital (Fig. 1). Twenty-one
patients were excluded, and two eligible patients declined to participate. The primary study group comprised sixty patients, including fty-three men and seven
women, with a mean age of thirty-eight years (range, twenty-two to fty-six years).
4
Table I in our original study presents the participants mean age at the time of
injury, body mass index (BMI), activity level (competitive athlete, recreational
athlete, or nonathletic), smoking habits, and previous Achilles tendon symptoms.
The sixty patients were randomized preoperatively to receive end-to-end
repair with use of the Krackow locking loop surgical technique alone (nonaugmented repair group; thirty-two patients) or the same repair augmented with a
down-turned gastrocnemius fascia ap according to the method described by
Silfverskiold (augmented repair group; twenty-eight patients). The surgeon who
operated on all of the patients performed the randomization by drawing randomly
mixed, numbered, and sealed opaque envelopes before the operation was started.
Both groups received postoperative treatment with an early mobilization brace. The short-term (twelve-month) results of this randomized con4
trolled study have been previously published .
Operative Techniques
All operations were performed by the same surgeon. In the nonaugmented group
(thirty-two patients), the tendon was repaired using the Krackow technique with two
0-gauge polydioxanone absorbable sutures (PDS; Ethicon) and smaller 2-0 apposition
19
sutures with polyglactin (Vicryl; Ethicon) . The augmented procedure (twenty-eight
patients) started with end-to-end repair identical to the nonaugmented procedure.
Then the repair was augmented with a 10-mm-wide central gastrocnemius aponeurosis ap turned down over the suture line and stitched to the Achilles tendon with
20
2-0 Vicryl . The ankle was placed in a neutral position, and the skin was closed with
4-0 nylon sutures (Ethilon; Ethicon). Postoperatively, a temporary below-the-knee
rigid plaster splint was applied with the ankle in a neutral position in all cases.
Postoperative Management
Postoperative treatment was identical in both groups. On the rst postoperative
day, all patients received an individual below-the-knee dorsal brace made of Soft
27 (2.6)
0.01
Cast material (3M), which they wore for three weeks; the brace allowed active free
4
plantar exion of the ankle and restricted dorsiexion to neutral . The patients
were allowed 20 kg of weight-bearing for three weeks, half weight-bearing for
three to six weeks, and full weight-bearing thereafter. They were instructed to
4
perform exercises according to a standard rehabilitation program .
Outcome Measures
We were able to contact fty-seven of the sixty patients from the original study after
thirteen years or more of follow-up. Two others were lost to follow-up (one was
living abroad and the other declined to participate), leaving fty-ve patients
(twenty-eight treated with nonaugmented repair and twenty-seven treated with
augmented repair) (Fig. 1). These patients were reexamined between December
2013 and March 2014, after an average of fourteen years of follow-up (standard
deviation [SD], 0.5 year). Patients visited the outpatient clinic at three months,
twelve months, and an average of fourteen years after surgery. The clinical observers were blinded to the treatment group. The primary outcome measure was
8
the Leppilahti score at the fourteen-year follow-up examination . Secondary outcomes included calf muscle isokinetic strength and health-related quality of life
21
measured with the RAND 36-item health survey . Complications and the need for
a reoperation were also recorded.
Leppilahti Score
The Leppilahti score, which includes subjective factors (pain, stiffness, muscle
weakness, footwear restriction, and subjective outcome) and objective factors
(active range of ankle motion and isokinetic calf muscle strength), was assessed
at three months, twelve months, and an average of fourteen years. The score for
isokinetic muscle strength is calculated from plantar and dorsiexion peak
8
torques at three different ankle test speeds as described by Leppilahti et al. . The
maximum Leppilahti score is 100 points, with 90 points considered excellent;
8
75 to 89 points, good; 60 to 74 points, fair; and <60 points, poor . Patients
completed the subjective part of the Leppilahti score independently.
Strength Measurements
The isokinetic strength of both ankles was assessed three months, twelve months,
and an average of fourteen years after surgery. At the three and twelve-month
follow-up visits, a physiotherapist performed strength measurements using a Lido
Multi-Joint II computer-based isokinetic dynamometer (Loredan Biomedical). At
the fourteen-year follow-up visit, the same physiotherapist and an exercise physiologist performed strength measurements using a CON-TREX biomechanical test
and training system computer-based isokinetic dynamometer (CMV). Before
testing, patients were informed of the measurement procedure. They performed
ergometer cycling for a ten-minute warm-up period and a few submaximal and
maximal repetitions of ankle exion and extension movements at the isokinetic test
velocity. During testing, the patient was in the supine position with the knee
supported in extension. The extent of ankle motion was from 10 of dorsiexion to
30 of plantar exion. The isokinetic plantar exion strengths of both ankles were
measured at speeds of 60/s, 120/s, and 180/s. Five maximal voluntary muscular
torque contractions were required.
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Mean (SD)
Nonaugmented
Repair
Augmented
Repair
P Value
General health
73 (20)
77 (13)
>0.9
75 (17)
58 (7)
Physical functioning
89 (17)
92 (8)
89 (16)
81 (7)
0.001
Mental health
84 (13)
89 (7)
>0.9
86 (11)
74 (3)
<0.0001
Social functioning
93 (13)
98 (5)
>0.9
95 (10)
80 (5)
<0.0001
Vitality
72 (19)
81 (11)
0.6
76 (17)
64 (5)
<0.0001
Domain
0.21
Finnish Reference
21
Population
P Value
<0.0001
Bodily pain
76 (26)
72 (19)
0.08
73 (24)
71 (6)
0.62
Role functioning/physical
91 (24)
88 (29)
0.08
88 (28)
69 (11)
<0.0001
Role functioning/emotional
95 (20)
99 (7)
0.7
96 (15)
74 (6)
<0.0001
*See the Appendix for the values adjusted for BMI. For the difference between the nonaugmented and augmented groups as determined with the
Student t test. For the difference between the entire study group and the Finnish reference population as determined with the Student t test.
From the best repetition, peak plantar exion torque at the angular
velocity of 60/s was recorded for each leg, and work-displacement curves
(from 210 to 30 of plantar exion) were calculated for both calves to assess
work-displacement decits for each 10 interval over the ankle joints range of
motion. The relative decit in peak torque and work-displacement relationships was calculated as: ([unaffected 2 affected side]/unaffected side) 100%.
The injured and uninjured sides were compared using absolute values of peak
torque and the work-displacement relationship.
Tendon Elongation
For the elongation measurements, radiographic markers were placed on both
4
sides of the rupture as previously described , and standardized radiographs
were made at one day, twelve months, and an average of fourteen years postoperatively. For each group, the Achilles tendon elongation measurements were
analyzed and correlated with clinical results.
Results
aseline patient parameters are shown in Table I.
Leppilahti Score
At the fourteen-year follow-up examination, the mean Leppilahti score was 87.1 points for the patients who had undergone
nonaugmented repair and 91.5 points for those treated with
augmented repair; the mean difference was 4.3 points (95%
condence interval [CI], 20.1 to 8.8 points), and the adjusted
mean difference was 3.9 points (95% CI, 20.7 to 8.5 points). In
the nonaugmented-repair group, the score was excellent for
thirteen patients (46%), good for thirteen (46%), and fair for
two (7%). In the augmented-repair group, the score was
Statistical Methods
Data were analyzed using an intention-to-treat principle. Simple between-group
comparisons were analyzed using the Student t test for continuous variables and
chi-square or Fisher exact test for categorical variables. Repeated-measures data
were analyzed using a linear mixed model with subjects set as random effects.
Between-measurement correlations were accounted for by testing different covariance patterns, the best of which was chosen using the Akaike information
criterion. Linear mixed-model analyses produced the p values for the overall
change over time (ptime), the average between-groups difference (pgroup), and the
interaction between time and group (ptime group). The original study showed
4
signicant baseline imbalance in BMI between the groups . This difference was
handled with adjusted analyses in a linear mixed model, and by using linear
regression for the Leppilahti score, strength measurements, tendon elongation,
and RAND-36 scores when comparing study groups. The results of both primary
and adjusted analyses are presented. Analyses were performed using IBM SPSS
Statistics for Windows (version 21.0) and SAS software (version 9.3; SAS Institute). Two-tailed p values are presented. A p value of <0.05 was considered
signicant. According to original power calculations, the present study had 90%
4
power to show a difference of 5.0 units in the Leppilahti score .
Fig. 2
Box plot comparing the Leppilahti scores between the study groups during the
follow-up period. The thick horizontal lines represent the medians, the boxes
represent the 25th and 75th percentiles, and the whiskers indicate the minimum
and maximum values. The p values were derived with BMI-adjusted analysis.
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Fig. 3
Fig. 4
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Fig. 5
Fig. 4 Intergroup comparison of the absolute median work-displacement values in plantar exion for the operatively treated legs measured at 10 intervals
over the ankle range of motion at the fourteen-year follow-up examination. The error bars represent the 25th and 75th percentiles. According to the
BMI-adjusted analysis, pdsplmnt < 0.001, pgroup = 0.20, and pdsplmnt group = 0.33. Fig. 5 Comparison of the three-month, twelve-month, and fourteen-year
median work-displacement decits in plantar exion of the operatively treated leg, as compared with the control (healthy) leg, measured at 10 intervals
over the ankle range of motion. The error bars represent the 25th and 75th percentiles.
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Appendix
A table showing the values in Table II adjusted for BMI is
available with the online version of this article as a data
supplement at jbjs.org. n
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