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Similar outcome observed between MIS and open surgery for Achilles tendon rupture
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June 2013
Similar outcome observed between MIS and open surgery for Achilles tendon rupture
Study Type:Randomized Trial
OE Level Evidence:2
Journal Level of Evidence:N/A
Efficacy and complications of open and minimally invasive surgery in acute Achilles tendon rupture: a prospective randomised clinical study--preliminary report
Int Orthop. 2013 Apr;37(4):625-9. doi: 10.1007/s00264-012-1737-9. Epub 2012 Dec 19Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
Fifty-one patients with acute Achilles tendon rupture were randomized to determine the comparative efficacy between minimally invasive surgery and traditional open surgery as treatment options. Follow-up was conducted for 24 months postoperatively. Results at final follow-up revealed that no patients in either group experienced a tendon re-rupture, while a similar number of infections was observed between groups. Measurements of clinical outcome were non-significantly different between groups.
Publication Funding Details
+
Funding:
Not Reported
Conflicts:
None disclosed
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
3/4
Randomization
2/4
Outcome Measurements
2/4
Inclusion / Exclusion
0/4
Therapy Description
3/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
While there are numerous interventions currently available for acute Achilles tendon rupture, advocacy of the optimal treatment remains primarily subjective, with a lack of agreement from contrasting evidence. Although surgical treatment can effectively reduce the risk of ruptures, the probability of surgical complications remains the main downside when comparing with non-operative treatment. More specifically, there is an ongoing debate on the comparative efficacy between open surgery and minimally invasive procedures. Ideally, minimally invasive surgery should reduce the incidence of complications, while maintaining the functional benefits of surgical intervention; however, there have been contradictory results reporting on minimally invasive management of Achilles tendon ruptures.
What was the principal research question?
Does minimally invasive surgery with the Achillon device for Achilles tendon rupture provide a more efficacious outcome compared to open surgery, when measured over 24 months postoperatively?
Study Characteristics
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Population:
51 patients with acute Achilles tendon rupture, presenting within 7 days of the injury.
Intervention:
Minimally Invasive Surgery (MIS): Patients underwent minimally invasive surgery with the Achillon device (Integra, NewDeal) (Mean age 44.8; n=24, 22 completed follow-up). Patients we placed in a blow the knee cast for 6 weeks and told to walk using crutches. After the 6 weeks the cast was removed and full weight bearing was allowed. No formal physiotherapy protocol was provided.
Comparison:
Open Surgery: Patients underwent traditional open surgery with Krackow-type sutures (Mean age 47.1; n=27, 25 completed follow-up). Patients we placed in a blow the knee cast for 6 weeks and told to walk using crutches. After the 6 weeks the cast was removed and full weight bearing was allowed. No formal physiotherapy protocol was provided.
Outcomes:
Primary outcome measure was the incidence of surgical complications, such as infections, re-ruptures, and sural nerve lesions. Secondary outcome included pain on a visual analog scale (VAS), return to work, time to return to sports or pre-injury activity level, calf circumference, the single heel-rise test to measure calf strength, ankle range of movement, and scar characteristics. Patients were asked to evaluate the aesthetics of their scar as very good, good, acceptable, or unacceptable.
Methods:
RCT, Prospective, Non-blinded
Time:
24 months
What were the important findings?
- There were no incidents of Achilles tendon re-ruptures or sural nerve lesions in either group. Wound infections were developed in one patient of the MIS group and in two patients who underwent open surgery.
- Pain was similar between groups, with a mean 1.6 in the MIS group and 1.7 in the open surgery group at the last follow-up (P>0.05).
- Ankle dorsiflexion for the treated limb at final follow-up was measured at 14.2 deg (+/-5.1) in the MIS group and 12.6 deg (+/-4.2) in the open surgery group. Ankle plantar flexion for the treated limb was 39.6 deg (+/-8.1) and 41.6 deg (+/-10.8), respectively. Differences between groups for dorsiflexion and plantar flexion were non-significant (P=0.40 and 0.50, respectively).
- At 24 months, calf circumference for the treated limb did not significantly differ between groups, measured at 36.4 cm (+/-3.3) in the MIS group and 37.4 (+/-4.8) in the open surgery group (P=0.53). At that same time point calf strength was similar between groups through the single heel-rise test (P=0.33).
- Return to work, measured at 24 months, was similar between groups: 4.8 weeks (+/-2.2) in the MIS group and 5.5 weeks (+/-2.7) in the open surgery group. A similar number of patients in each group returned to their original activity level in both groups (46% overall returned to pre-injury status).
- Scar length was significantly shorter in the MIS group (4.0 +/- 0.9 cm) compared to the open surgery group (14.5 +/- 3.3 cm) (P=0.005). Two patients who underwent open surgery developed keloid formations, although were still graded as acceptable.
What should I remember most?
Despite the low number of severe complications observed with the Achillon device minimally invasive procedure, the incidence was not significantly reduced compared to traditional open surgery with Krackow sutures. Scar length was shorter with the minimally invasive procedure; however, this result did not appear to impact patients' self-assessment of the scar aesthetics. Clinical outcome was similar between the two procedures.
How will this affect the care of my patients?
The return to pre-injury activity level in both groups was not as high as reported in previous literature, which was thought to be due to the non-weight bearing and immobilization protocol in the immediate postoperative period. It should also be noted that no formal physiotherapy protocol was administered. This goes to suggest that changes in the postoperative protocol (ie. early weight-bearing and mobilization) following the MIS procedure might reveal better results. The present study suggests that operative management of Achilles tendon rupture with minimally invasive surgery does not appear to elicit a more favorable outcome compared to open surgery.
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