A Randomized Controlled Trial Comparing Traditional Plaster Cast Rehabilitation With Functional Walking Boot Rehabilitation for Acute Achilles Tendon Ruptures

2020 ◽  
Vol 48 (11) ◽  
pp. 2755-2764 ◽  
Author(s):  
Julian F. Maempel ◽  
Nick D. Clement ◽  
Andrew D. Duckworth ◽  
Oisin J.F. Keenan ◽  
Tim O. White ◽  
...  
Keyword(s):  
Achilles Tendon ◽  
Functional Outcomes ◽  
Controlled Trial ◽  
Achilles Tendon Rupture ◽  
Controlled Clinical Trial ◽  
Delayed Presentation ◽  
Foot And Ankle ◽  
Functional Rehabilitation ◽  
Randomized Controlled ◽  
Patient Reported

Background: There has been a shift toward functional nonoperative rehabilitation in the treatment of Achilles tendon rupture (ATR) despite a shortage of studies directly comparing nonoperative functional rehabilitation with traditional nonoperative immobilization. Purpose: To compare patient-reported outcome measures and functional outcomes for nonoperatively treated ATR with traditional cast immobilization or functional rehabilitation in a walking boot. Study Design: Randomized controlled clinical trial; Level of evidence, 2. Methods: In a single-center nonblinded study, 140 patients were randomized to compare treatment for acute ATR in (1) an immobilizing cast in reducing degrees of equinus over a 10-week period with 8 weeks of nonweightbearing mobilization or (2) a walking boot for 8 weeks with reducing equinus and immediate full weightbearing. Exclusion criteria were delayed presentation >2 weeks after injury, tendon reruptures, and latex allergy. Analysis was undertaken on an intention-to-treat basis. Results: A total of 69 patients (median age, 41 years [interquartile range, 33-50.5 years]) were randomized to walking boot treatment and 71 patients (41 [32-49]) to cast treatment. At 6 months, patients treated in a walking boot reported better Short Musculoskeletal Function Assessment (SMFA) dysfunction index (6.62 [2.21-12.50] vs 10.66 [4.96-13.42]; P = .050), SMFA bother index (7.29 [2.08-14.58] vs 10.42 [5.73-19.27]; P = .04), Achilles Tendon Total Rupture Score (71.5 [53.50-84.25] vs 54.0 [37-76]; P = .01), and Foot and Ankle Questionnaire core score (91 [81.89-97.55] vs 85 [78.25-92.09]; P = .04). At 1 year, there was no difference in SMFA dysfunction index (2.21 [0.74-5.88] vs 2.94 [1.47-6.62]; P = .25), SMFA bother index (2.08 [0-9.38] vs 5.21 [0.52-11.98]; P = .25), Achilles Tendon Total Rupture Score (92 [72.50-96] vs 87.5 [66.0-94.75]; P = .21), or Foot and Ankle Questionnaire core score (97.75 [89.46-99.00] vs 95.50 [90.88-97.50]; P = .18). Rerupture occurred in 5 and 11 patients ( P = .075) and venous thromboembolism in 2 and 3 patients ( P = .67) in the boot and cast groups, respectively. Fifteen patients in the boot group but none in the cast group had skin problems ( P < .001). Patients treated in a boot returned to driving at a median 12 weeks (vs 13 weeks for cast; P = .045), but there was no difference in time to return to work ( P = .48). Conclusion: Functional rehabilitation with early weightbearing is a safe alternative to traditional immobilizing treatment for ATR, giving better early functional outcomes, albeit with a higher incidence of transient minor skin complications. Registration: NCT02598843 (ClinicalTrials.gov identifier).

scholarly journals Defining Components of Early Functional Rehabilitation for Acute Achilles Tendon Rupture: A Systematic Review

2019 ◽  
Vol 7 (11) ◽  
pp. 232596711988407 ◽  
Author(s):  
Jennifer A. Zellers ◽  
Marianne Christensen ◽  
Inge Lunding Kjær ◽  
Michael Skovdal Rathleff ◽  
Karin Grävare Silbernagel
Keyword(s):  
Systematic Review ◽  
Achilles Tendon ◽  
Range Of Motion ◽  
Outcome Measures ◽  
Functional Outcomes ◽  
Tendon Rupture ◽  
Achilles Tendon Rupture ◽  
Whole Body ◽  
Functional Rehabilitation ◽  
Patient Reported

Background: Early functional rehabilitation is frequently discussed in treating Achilles tendon rupture. A consistent definition of what constitutes early functional rehabilitation has not been established across the literature, despite studies supporting its efficacy. A standardized definition would be helpful to pool data across studies, allow for between-study comparisons, and ultimately work toward developing clinical guidelines. Purpose: To define early functional rehabilitation (including when it is initiated and what it entails) when used to treat Achilles tendon rupture and to identify outcome measures for evaluating the effect of treatment. Study Design: Systematic review; Level of evidence, 4. Methods: Ovid MEDLINE, EMBASE, PEDro, CINAHL, and Cochrane databases were searched for relevant studies. Eligibility criteria for selecting studies consisted of randomized controlled trials, cohort studies, and case series (≥10 participants) including weightbearing or exercise-based interventions within 8 weeks after Achilles tendon rupture. Results: A total of 174 studies published between 1979 and 2018 were included. Studies were rated a median (interquartile range [IQR]) of 17 (15-20) on the Downs & Black checklist and included 9098 participants. Early functional rehabilitation incorporated weightbearing (95%), range of motion (73%), and isometric/strengthening exercises (50%). Weightbearing was initiated within the first week, whereas exercise (eg, ankle range of motion, strengthening, whole-body conditioning) was initiated in the second week. Initiation of exercises varied based on whether treatment was nonsurgical (mean, 3.0 weeks; IQR, 2.0-4.0 weeks) or simple (mean, 2.0 weeks; IQR, 0.0-2.3 weeks) or augmented surgical repair (mean, 0.5 weeks; IQR, 0.0-2.8 weeks) ( P = .017). Functional outcomes including ankle range of motion (n = 84) and strength (n = 76) were reported in 130 studies. Other outcome domains included patient-reported outcomes (n = 89), survey-based functional outcomes (n = 50), and tendon properties (n = 53). Conclusion: Early functional rehabilitation includes weightbearing and a variety of exercise-based interventions initiated within the first 2 weeks after acute Achilles tendon rupture/repair. Because early functional rehabilitation has lacked a standardized definition, interventions and outcome measures are highly variable, and pooling data across studies should be done with attention paid to what was included in the intervention and how treatment was assessed.

scholarly journals A randomized controlled trial comparing tibial migration of the ATTUNE cemented cruciate-retaining knee prosthesis with the PFC-sigma design

2020 ◽  
Vol 102-B (9) ◽  
pp. 1158-1166
Author(s):  
Bart L. Kaptein ◽  
Peter den Hollander ◽  
Bregje Thomassen ◽  
Martha Fiocco ◽  
Rob G. H. H. Nelissen
Keyword(s):  
Tibial Component ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Controlled Clinical Trial ◽  
Fixed Bearing ◽  
Cruciate Retaining ◽  
Cement Interface ◽  
Randomized Controlled ◽  
Press Fit ◽  
Patient Reported

Aims The primary objective of this study was to compare migration of the cemented ATTUNE fixed bearing cruciate retaining tibial component with the cemented Press-Fit Condylar (PFC)-sigma fixed bearing cruciate retaining tibial component. The secondary objectives included comparing clinical and radiological outcomes and Patient Reported Outcome Measures (PROMs). Methods A single blinded randomized, non-inferiority study was conducted including 74 patients. Radiostereometry examinations were made after weight bearing, but before hospital discharge, and at three, six, 12, and 24 months postoperatively. PROMS were collected preoperatively and at three, six, 12, and 24 months postoperatively. Radiographs for measuring radiolucencies were collected at two weeks and two years postoperatively. Results The overall migration (mean maximum total point motion (MPTM)) at two years was comparable: mean 1.13 mm (95% confidence interval (CI), 0.97 to 1.30) for the ATTUNE and 1.16 mm (95% CI, 0.99 to 1.35) for the PFC-sigma. At two years, the mean backward tilting was -0.43° (95% CI, -0.65 to -0.21) for the ATTUNE and 0.08° (95% CI -0.16 to 0.31), for the PFC-sigma. Overall migration between the first and second postoperative year was negligible for both components. The clinical outcomes and PROMs improved compared with preoperative scores and were not different between groups. Radiolucencies at the implant-cement interface were mainly seen below the medial baseplate: 17% in the ATTUNE and 3% in the PFC-sigma at two weeks, and at two years 42% and 9% respectively (p = 0.001). Conclusion In the first two postoperative years the initial version of the ATTUNE tibial component was not inferior with respect to overall migration, although it showed relatively more backwards tilting and radiolucent lines at the implant-cement interface than the PFC-sigma. The version of the ATTUNE tibial component examined in this study has subsequently undergone modification by the manufacturer. Level of Evidence: 1 (randomized controlled clinical trial) Cite this article: Bone Joint J 2020;102-B(9):1158–1166.

scholarly journals Risk of Deep Vein Thrombosis After Acute Achilles Tendon Rupture: A Secondary Analysis of a Randomized Controlled Trial Comparing Early Controlled Motion of the Ankle Versus Immobilization

2020 ◽  
Vol 8 (4) ◽  
pp. 232596712091590 ◽  
Author(s):  
Kristoffer Weisskirchner Barfod ◽  
Emil Graakjær Nielsen ◽  
Beth Hærsted Olsen ◽  
Pablo Gustavo Vinicoff ◽  
Anders Troelsen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Achilles Tendon ◽  
Tendon Rupture ◽  
Controlled Trial ◽  
Achilles Tendon Rupture ◽  
Vein Thrombosis ◽  
Randomized Controlled ◽  
Deep Vein ◽  
D Dimer

Background: Immobilization of the ankle joint has been suggested as a key element in the pathogenesis leading to deep vein thrombosis (DVT). Purpose: To investigate whether early controlled ankle motion (ECM) could reduce the incidence of DVT compared with immobilization (IM) in the treatment of acute Achilles tendon rupture. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Patients aged 18 to 70 years were eligible for inclusion, and treatment was nonoperative. The ECM group performed movements of the ankle 5 times a day from weeks 3 to 8 after rupture. The control group was immobilized for 8 weeks. The outcome measure was DVT diagnosed with color Doppler ultrasound for above- and below-knee DVT at 2 and 8 weeks. The Achilles tendon Total Rupture Score, the heel-rise work test, and the Copenhagen Achilles ultrasonographic Length Measurement were performed at 4-, 6-, and 12-month follow-up. Results: A total of 189 patients were assessed for eligibility from February 2014 to December 2016. Of these, 130 were randomized: 68 patients were allocated to the ECM group and 62 to the IM group. All patients participated in follow-up at 8 weeks assessing for DVT. In total, 62 (47.7%) patients were diagnosed with DVT: 33 of 68 (48.5%) in the ECM group and 28 of 61 (46.8%) in the IM group ( P = .84). DVT did not affect treatment outcomes at 4, 6, and 12 months. D-dimer had low sensitivity (71%) for detecting DVT. Conclusion: We found that 1 in 2 patients presented with DVT in nonoperative treatment of acute Achilles tendon rupture. The ECM protocol revealed no benefit versus IM in reducing the incidence of DVT. DVT did not influence functional and patient-reported outcomes the first year after rupture. D-dimer seems an inappropriate test for detection of DVT in patients with acute Achilles tendon rupture. Registration: NCT02015364 ( ClinicalTrials.gov identifier).

scholarly journals Slowed-Down Rehabilitation Following Percutaneous Repair of Achilles Tendon Rupture

2021 ◽  
pp. 107110072110385
Author(s):  
Nicola Maffulli ◽  
Nikolaos Gougoulias ◽  
Gayle D. Maffulli ◽  
Francesco Oliva ◽  
Filippo Migliorini
Keyword(s):  
Achilles Tendon ◽  
Functional Outcomes ◽  
Achilles Tendon Rupture ◽  
Rehabilitation Program ◽  
Calf Circumference ◽  
Level Of Evidence ◽  
Traditional Group ◽  
Percutaneous Repair ◽  
Patient Reported ◽  
Group 1

Background: Following percutaneous repair of acute Achilles tendon (AT) ruptures, early postoperative weightbearing is advocated; however, it is debatable how aggressive rehabilitation should be. We compared the clinical and functional outcomes in 2 groups of patients who followed either our “traditional” or a “slowed down” rehabilitation after percutaneous surgical repair. Methods: Sixty patients were prospectively recruited to a slowed down (29 patients) or a traditional (31 patients) rehabilitation program. Both groups were allowed immediate weightbearing postoperatively; a removable brace with 5 heel wedges was applied at 2 weeks. In the slowed-down group, 1 wedge was removed after 4 weeks. Gradual removal of the boot took place after 4 wedges were kept for 4 weeks. In the traditional group, 1 wedge was removed every 2 weeks, with removal of the boot after 2 wedges had been kept for 2 weeks. The AT Resting Angle (ATRA) evaluated tendon elongation. Patient reported functional outcomes were assessed using the AT Rupture Score (ATRS). Calf circumference difference and the isometric plantarflexion strength of the gastro-soleus complex were evaluated. Results: At the 12-month follow-up, both ATRA and ATRS were more favorable in the slowed-down group. The isometric strength and the calf circumference were more similar to the contralateral leg in the slowed-down group than in the traditional one. Conclusion: Following percutaneous repair of acute Achilles tendon patients undergoing slowed down rehabilitation performed better than the traditional one. These conclusions must be considered within the limitations of the present study. Level of Evidence: Level II, prospective comparative study.

scholarly journals Does Early Functional Mobilization Affect Long-Term Outcomes After an Achilles Tendon Rupture? A Randomized Clinical Trial

2020 ◽  
Vol 8 (3) ◽  
pp. 232596712090652 ◽  
Author(s):  
Susanna Aufwerber ◽  
Annette Heijne ◽  
Gunnar Edman ◽  
Karin Grävare Silbernagel ◽  
Paul W. Ackermann
Keyword(s):  
Achilles Tendon ◽  
General Health ◽  
Tendon Rupture ◽  
Standard Treatment ◽  
Negative Impact ◽  
Controlled Trial ◽  
Achilles Tendon Rupture ◽  
Control Group ◽  
Ankle Motion ◽  
Patient Reported

Background: Functional deficits and health-related impairments are common after an Achilles tendon rupture (ATR). Rehabilitation protocols vary greatly, and few studies have allowed loading in combination with ankle motion immediately after surgery (ie, early functional mobilization [EFM]). It is unclear whether EFM may counteract the negative impact of ankle immobilization after an ATR. Purpose: The primary aim of this study was to assess the efficacy of EFM compared with standard treatment (ie, 2 weeks of unloading in a plaster cast followed by 4 weeks of weightbearing in an orthosis) regarding patient-reported and functional outcomes in patients with an ATR after acute operative repair. The secondary aim was to explore whether the occurrence of deep venous thrombosis (DVT) during the 2 postoperative treatments affected outcomes. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 135 patients who underwent ATR repair, randomized to either EFM, including immediate postoperative loading and ankle motion, or standard treatment, were evaluated with functional tests and 5 self-administered outcome questionnaires at 6 and 12 months postoperatively. Results: At 6 months, the EFM group scored higher on the RAND 36-Item Health Survey (RAND-36) questionnaire subscales of general health and vitality ( P < .05) compared with the control group. No significant differences between the groups were found on disease-specific questionnaires (Achilles tendon Total Rupture Score [ATRS] and Foot and Ankle Outcome Score [FAOS]). At 12 months, no significant differences on any of the patient-reported outcome measures or the functional heel-rise test were seen between the groups. The RAND-36 subscale of general health, however, exhibited higher values in the EFM group (82.6 ± 16.9) than the control group (77.1 ± 17.0) ( P = .051) at 12 months after the injury. Patients sustaining DVT postoperatively had lower self-reported outcomes on the ATRS, FAOS, and RAND-36 questionnaires at 6 and 12 months compared with patients not having sustained DVT (all P < .05). Conclusion: This study demonstrated that an accelerated postoperative protocol with immediate loading and ankle motion resulted in better general health and vitality at 6 months. However, there were no differences between the groups in the recovery of heel-rise function. Future studies should focus on the means to reduce the risk of DVT to improve patient outcomes after ATR. Registration: NCT02318472 (ClinicalTrials.gov identifier).

scholarly journals Individualized treatment for acute Achilles tendon rupture based on the Copenhagen Achilles Rupture Treatment Algorithm (CARTA): a study protocol for a multicenter randomized controlled trial

2020 ◽  
Author(s):  
Maria Swennergren Hansen ◽  
Marianne Toft Vestermark ◽  
Per Hölmich ◽  
Morten Tange Kristensen ◽  
Kristoffer Weisskirchner Barfod
Keyword(s):  
Randomized Controlled Trial ◽  
Achilles Tendon ◽  
Tendon Rupture ◽  
Controlled Trial ◽  
Achilles Tendon Rupture ◽  
Treatment Algorithm ◽  
Intervention Group ◽  
Individualized Treatment ◽  
Control Group ◽  
Randomized Controlled

Abstract Background: An individualized treatment algorithm (Copenhagen Achilles Rupture Treatment Algorithm - CARTA) based on the ultrasonographic appearance of an acute Achilles tendon rupture has been developed aiming to select the correct patients for operative and non-operative treatment. The objective of this study is to investigate if this individualized treatment algorithm gives a better functional outcome than treating all patients either operatively or non-operatively per default. Methods: This study is conducted as a multicenter three-armed randomized controlled trial. Participants are included from four hospitals in Denmark and randomized 1:1:1 to one of three parallel groups: 1) Intervention group: Participants are treated according to an individualized treatment algorithm, 2) Control group A: Participants are treated non-operative, 3) Control group B: Participants are treated operative. The individualized treatment algorithm for the intervention group is based on an ultrasonographic examination; tendon overlap and elongation below 7% is to be treated non-operative, while no tendon overlap and and/or elongation above 7% will be treated operative. 300 participants will be included over a period of 3 years. The primary outcome is the heel-rise work test at 12 months post-injury. Secondary outcomes are tendon elongation, the Achilles tendon Total Rupture Score (ATRS), the rate of re-ruptures and other complications. The primary analysis will be conducted as intention-to-treat analysis.Discussion: This trial will indicate if treatment of acute Achilles tendon rupture can be individualized based on the elongation and tendon overlap. It is hypothesized that different patients will benefit from different treatment instead of offering all the same treatment. Trial registration: ClinicalTrials.gov Identifier: NCT03525964. Registered 16 May 2018.

scholarly journals 3 Platelet rich plasma for acute achilles tendon rupture: a double-blind, multicentre, randomised, placebo-controlled trial

2019 ◽  
Vol 53 (13) ◽  
pp. 843.3-844
Author(s):  
DJ Keene ◽  
J Alsousou ◽  
P Harrison ◽  
P Hulley ◽  
S Wagland ◽  
...  
Keyword(s):  
Achilles Tendon ◽  
Goal Attainment ◽  
Tendon Rupture ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Achilles Tendon Rupture ◽  
Soft Tissue Injuries ◽  
Double Blind ◽  
Patient Reported ◽  
Secondary Outcomes

AimSlow recovery and disability after Achilles tendon rupture are major challenges. Platelet Rich Plasma (PRP) is an autologous supraphysiological concentration of platelets from whole blood that has demonstrated positive cellular and physiological effects on healing in the laboratory and is widely used in musculoskeletal treatments. However, evidence from adequately powered, robust clinical trials is lacking. We aimed to determine the clinical efficacy of PRP for treatment of acute Achilles tendon rupture.Methods230 adults starting Achilles rupture non-surgical management within 12 days of injury were randomised to PRP injection or dry needle insertion to the rupture gap, under local anaesthetic. Participants were blinded to study treatment and received standardised rehabilitation. Blinded outcome assessments were at 4, 7, 13, and 24 weeks. The primary outcome was muscle-tendon function assessed by work performed during the heel-rise endurance test (HRET), measured with the Limb Symmetry Index (LSI) (0–100%; 100% denotes full recovery) at 24 weeks. Secondary outcomes were the Achilles Tendon Rupture Score (ATRS), quality of life (SF-12), pain and goal attainment. The trial was prospectively registered.ResultsOf 230 participants, 114 were allocated to PRP injection (103 received PRP), 116 were allocated to and received placebo. At 24 weeks, 201/230 (87%) completed the HRET and 214/230 (93%) completed patient reported outcomes. Participant characteristics between the groups were similar. There was no difference between groups at 24 weeks in LSI (mean difference = -4.373; 95% CI −11.217 to 2.471; p=0.195). There were no differences in the secondary outcomes and adverse event rates.ConclusionThis trial design and standardised PRP preparation secure the first robust clinical trial evidence for PRP in managing Achilles tendon rupture, and suggest that PRP offers no patient benefit. The use of PRP in soft tissue injuries must be questionable unless supported by equally robust evidence indicating positive outcomes.

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