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Non-operative management of posterior tibialis tendon dysfunction: design of a randomized clinical trial [NCT00279630].

ABSTRACT: Posterior tibialis tendon dysfunction (PTTD) is a common cause of foot pain and dysfunction in adults. Clinical observations strongly suggest that the condition is progressive. There are currently no controlled studies evaluating the effectiveness of exercise, orthoses, or orthoses and exercise on Stage I or IIA PTTD. Our study will explore the effectiveness of an eccentric versus concentric strengthening intervention to results obtained with the use of orthoses alone. Findings from this study will guide the development of more efficacious PTTD intervention programs and contribute to enhanced function and quality of life in persons with posterior tibialis tendon dysfunction.This paper presents the rationale and design for a randomized clinical trial evaluating the effectiveness of a treatment regime for the non-operative management of Stage I or IIA PTTD.We have presented the rationale and design for an RCT evaluating the effectiveness of a treatment regimen for the non-operative management of Stage I or IIA PTTD. The results of this trial will be presented as soon as they are available.

SUBMITTER: Kulig K

PROVIDER: S-EPMC1513568 | biostudies-literature | 2006 Jun

REPOSITORIES: biostudies-literature

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Non-operative management of posterior tibialis tendon dysfunction: design of a randomized clinical trial [NCT00279630].

Kulig Kornelia K Pomrantz Amy B AB Burnfield Judith M JM Reischl Stephen F SF Mais-Requejo Susan S Thordarson David B DB Smith Ronald W RW

BMC musculoskeletal disorders 20060606

<h4>Background</h4>Posterior tibialis tendon dysfunction (PTTD) is a common cause of foot pain and dysfunction in adults. Clinical observations strongly suggest that the condition is progressive. There are currently no controlled studies evaluating the effectiveness of exercise, orthoses, or orthoses and exercise on Stage I or IIA PTTD. Our study will explore the effectiveness of an eccentric versus concentric strengthening intervention to results obtained with the use of orthoses alone. Finding ...[more]

PMID: 16756656

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Project description:Background:The management of acute Achilles tendon ruptures is controversial, and most injuries are treated with surgery in the USA. The cost utility of operative versus non-operative treatment of acute Achilles tendon injury is unclear. Questions/Purposes:The purpose of this study was to compare the cost-effectiveness of operative versus functional non-operative treatment of acute Achilles tendon ruptures. Methods:A Markov cost-utility analysis was conducted from the societal perspective using a 2-year time horizon. Hospital costs were derived from New York State billing data, and physician and rehabilitation costs were derived from the Medicare physician fee schedule. Indirect costs of missed work were calculated using estimates from the US Bureau of Labor Statistics. Rates of re-rupture, major and minor complications, and the associated costs were obtained from the literature. Effectiveness was expressed in quality-adjusted life years (QALYs). For the base-case analysis, operative and non-operative patients were assumed to have the same utilities (quality of life) following surgery. Deterministic and probabilistic sensitivity analyses were conducted to evaluate the robustness of model assumptions. Results:In the base-case model, non-operative management of acute Achilles tendon ruptures dominated operative management, resulting in both lower costs and greater QALY gains. The differences in costs and effectiveness were relatively small. The benefit of non-operative treatment was 1.69 QALYs, and the benefit of operative treatment was 1.67 QALYs. Similarly, the total cost of operative and non-operative management was $13,936 versus $13,413, respectively. In sensitivity analyses, surgical costs and days of missed work were important drivers of cost-effectiveness. If hospitalization costs dropped below $2621 (compared with $3145) or the hourly wage rose above $29 (compared with $24), then operative treatment became a cost-effective strategy at the willingness-to-pay threshold of $50,000/QALY. The model results were also highly sensitive to the relative utilities for operative versus non-operative treatment. If non-operative utilities decreased relative to operative utilities by just 2%, then operative management became the dominant treatment strategy. Conclusion:For acute Achilles tendon ruptures, non-operative treatment provided greater benefits and lower costs than operative management in the base case; however, surgical costs and the economic impact associated with return to work are important determinants of the preferred cost-effective strategy.

Project description:BackgroundSymptoms associated with pes planovalgus or flatfeet occur frequently, even though some people with a flatfoot deformity remain asymptomatic. Pes planovalgus is proposed to be associated with foot/ankle pain and poor function. Concurrently, the multifactorial weakness of the tibialis posterior muscle and its tendon can lead to a flattening of the longitudinal arch of the foot. Those affected can experience functional impairment and pain. Less severe cases at an early stage are eligible for non-surgical treatment and foot orthoses are considered to be the first line approach. Furthermore, strengthening of arch and ankle stabilising muscles are thought to contribute to active compensation of the deformity leading to stress relief of soft tissue structures. There is only limited evidence concerning the numerous therapy approaches, and so far, no data are available showing functional benefits that accompany these interventions.MethodsAfter clinical diagnosis and clarification of inclusion criteria (e.g., age 40-70, current complaint of foot and ankle pain more than three months, posterior tibial tendon dysfunction stage I & II, longitudinal arch flattening verified by radiography), sixty participants with posterior tibial tendon dysfunction associated complaints will be included in the study and will be randomly assigned to one of three different intervention groups: (i) foot orthoses only (FOO), (ii) foot orthoses and eccentric exercise (FOE), or (iii) sham foot orthoses only (FOS). Participants in the FOO and FOE groups will be allocated individualised foot orthoses, the latter combined with eccentric exercise for ankle stabilisation and strengthening of the tibialis posterior muscle. Participants in the FOS group will be allocated sham foot orthoses only. During the intervention period of 12 weeks, all participants will be encouraged to follow an educational program for dosed foot load management (e.g., to stop activity if they experience increasing pain). Functional impairment will be evaluated pre- and post-intervention by the Foot Function Index. Further outcome measures include the Pain Disability Index, Visual Analogue Scale for pain, SF-12, kinematic data from 3D-movement analysis and neuromuscular activity during level and downstairs walking. Measuring outcomes pre- and post-intervention will allow the calculation of intervention effects by 3×3 Analysis of Variance (ANOVA) with repeated measures.DiscussionThe purpose of this randomised trial is to evaluate the therapeutic benefit of three different non-surgical treatment regimens in participants with posterior tibial tendon dysfunction and accompanying pes planovalgus. Furthermore, the analysis of changes in gait mechanics and neuromuscular control will contribute to an enhanced understanding of functional changes and eventually optimise conservative management strategies for these patients.Trial registrationClinicalTrials.gov Protocol Registration System: ClinicalTrials.gov ID NCT01839669.

Project description:BACKGROUND:Proximal humerus fractures are the third most common fracture in the elderly population and are expected to increase due to the aging population. Surgical fixation with locking plate technology has increased over the last decade despite a lack of proven superiority in the literature. Three previous randomized controlled trials have not shown a difference in patient-centered outcomes when comparing non-operative treatment with open reduction and internal fixation. Low patient enrollment and other methodological concerns however limit the generalizability of these conclusions and as a result, management of these fractures remains a controversy. By comparing the functional outcomes of locked plate surgical fixation versus non-operative treatment of displaced three and four-part proximal humerus fractures in the elderly population with a large scale, prospective, multi-centered randomized controlled trial, the optimal management strategy for this common injury may be determined. METHODS:We will conduct a prospective, single blind randomized controlled parallel arm trial to compare non-operative management of proximal humerus fractures with open reduction and internal fixation using locked plating technology. One-hundred and sixty patients > age 60 with acute 3- or 4- part proximal humerus fractures will be randomized to either open reduction and internal fixation with locked plating technology or non-operative management treatment arms. The primary outcome measure is the Constant Score at 24 months post-operative. Secondary outcome measures include the American Shoulder and Elbow Surgeon's Score (ASES), EuroQol EQ-5D-5 L Health Questionnaire Score, short form PROMIS upper extremity score and IPAQ for the elderly score. Further outcome measures include assessment of the initial classification, displacement and angulation and the quality of surgical reduction via a standard computed tomography (CT) scan; rates of non-union, malunion, arthrosis, osteopenia or other complications including infection, nerve injury, intra-articular screw penetration, reoperation rates and hospital re-admission rates. DISCUSSION:The results of this trial will provide Level 1 evidence to guide decision-making in the treatment of proximal humerus fractures in the elderly population. TRIAL REGISTRATION:ClinicalTrials.gov NCT02362100 . Registered 5 Feb 2015.

Project description:BackgroundThere are limited data reporting the outcome of patients with non-operatively managed medial malleolus fractures compared to those treated surgically in the presence of fibular stabilisation for unstable fractures of the ankle. Conservative management could result in fewer complications, reduced surgical time and lower cost. The purpose of this study is to determine if any difference exists in patient reported and surgical outcomes 1 year after surgery between operative and non-operative treatment of medial malleolar fractures in combination with stabilisation of the lateral malleolus.Methods/designThis is a single-centre, prospective, randomised controlled trial that aims to randomise 154 participants with an unstable ankle fracture to 'non-fixation' (n = 77) or 'fixation' (n = 77) of an associated well-reduced medial malleolus fracture following fibular stabilisation. The study will include patients ≥ 16 years of age with a closed bimalleolar or trimalleolar ankle fracture who are able to consent, complete questionnaires in the English language, and complete follow-up over a 1-year period. Randomisation will occur intra-operatively when the medial malleolus fracture is deemed 'well-reduced', with 2 mm or less of fluoroscopic displacement. The technique for fixation of both the medial and lateral malleoli is at the discretion of the operating surgeon. Patient-reported, observer-rated, and radiographic assessments will be collected at baseline and then at the following post-operative assessment points: 2 weeks, 6 weeks and 1 year. Postal questionnaire outcome data will be collected at 3 and 6 months. The primary outcome measure will be the Olerud Molander Ankle Score (OMAS) at 1 year following surgery. Secondary outcome measures will include the Manchester-Oxford Foot Questionnaire (MOXFQ), EuroQol-5D (EQ-5D), pain, treatment satisfaction, time to return to activity, operative tourniquet time, and complications.DiscussionThere is only one previous randomised trial comparing non-fixation with fixation of associated medial malleolus fractures but that was limited by the lack of baseline patient-reported outcome data and an inferior sample size. This current prospective trial aims to provide high-quality evidence regarding the requirement for medial malleolar fixation in unstable ankle fractures.Trial registrationClinicalTrials.gov, NCT03362229 . Registered retrospectively on 5 December 2017.

Dataset Information

Non-operative management of posterior tibialis tendon dysfunction: design of a randomized clinical trial [NCT00279630].

Publications

Non-operative management of posterior tibialis tendon dysfunction: design of a randomized clinical trial [NCT00279630].

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