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result(s) for
"Tenotomy - methods"
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A single-center, single-blinded, randomized, parallel-group, non-inferiority trial to compare the efficacy of a 22-gauge needle versus a 15 blade to perform an Achilles tendon tenotomy in 244 clubfeet—study protocol
by
Chinoy, Muhammad Amin
,
Ghufran Syed, Jabbar
,
Khan, Mansoor Ali
in
Achilles tendon
,
Achilles Tendon - surgery
,
Biomedicine
2023
Background
Achilles tendon tenotomy is an integral part of the Ponseti method, aimed at correcting residual equinus and lack of dorsiflexion after correction of the adductus deformity in clubfoot. Percutaneous tenotomy using a number 15 scalpel blade is considered the gold standard, resulting in excellent results with minimal complications. The use of a large-bore needle to perform Achilles tendon tenotomies has been described in literature, but a large-scale randomized controlled trial is currently lacking. In this trial, we aim to show the non-inferiority of the needle tenotomy technique compared to the gold standard blade tenotomy technique.
Methods
We will randomize 244 feet into group A: needle tenotomy or group B: blade tenotomy. Randomization will be done using a block randomization with random block sizes and applying a 1:1 allocation to achieve an intervention and control group of the exact same size. Children will be evaluated at 3 weeks and 3 months post-tenotomy for primary and secondary clinical outcomes. The primary clinical outcome will be the range of dorsiflexion obtained the secondary clinical outcomes will be frequency of minor and major complications and Pirani score. The non-inferiority margin was set at 4°, and thus, the null hypothesis of inferiority of the needle technique will be rejected if the mean difference between both techniques is less than 4°. The statistical analysis will use a multi-level mixed effects linear regression model for the primary outcomes and a multi-level mixed effects logistic regression model for the secondary clinical outcomes. The physician performing the evaluations post-tenotomy will be the only one blinded to group allocation.
Trial registration
This trial was registered prospectively with ClinicalTrials.gov registration number:
NCT04897100
on 21 May 2021.
Journal Article
Reparable rotator cuff tears with concomitant long-head biceps lesions: tenotomy or tenotomy/tenodesis?
2012
Purpose
The aim of the study was to determine clinical, functional, and radiological results of two groups of patients affected by rotator cuff tear with concomitant degeneration of the long head of the biceps tendon treated with tenotomy/tenodesis or tenotomy.
Methods
Sixty-five patients were randomly assigned to group A (35 patients, tenotomy/tenodesis) and group B (30 patients, tenotomy). All patients underwent physical examination and simple shoulder test and Constant score scales. Moreover, they underwent dynamometric tests and power Doppler ultrasonography in order to evaluate the exact location of the long-head biceps and the vascularization of the repaired rotator cuff and of the long-head biceps.
Results
Physical examination and clinical evaluation scales showed satisfactory results in both groups, with no significant differences (n.s.). Popeye sign was detected in 5 patients (17%) of group B and in no one patient of group A. Ultrasound examination showed the LHB within the bicipital groove in 80% of group A and group B. Power Doppler ultrasonography showed signs of vascularization of the LHB in 20% of patients of group A and in 40% of group B and signs of vascularization of the repaired rotator cuff in 28% of group A and 40% of group B.
Conclusions
Long head of the biceps tenotomy combined with tenodesis does not provide any significant clinical or functional improvement than isolated tenotomy. However, the incidence of the Popeye sign is significantly higher, even though not associated with any functional disfunction.
Level of evidence
Therapeutic study, Level II.
Journal Article
GUIDANCE study: guided growth of the proximal femur to prevent further hip migration in patients with cerebral palsy—study protocol for a multicentre randomised controlled trial
by
Eygendaal, Denise
,
van Stralen, Renée Anne
,
Witbreuk, Melinda Maria Eva Helena
in
Caregivers
,
Cerebral palsy
,
Cerebral Palsy - complications
2024
IntroductionUp to one-third of patients with cerebral palsy (CP) develop hip migration. Current standard care for early hip migration is bilateral adductor-psoas tenotomy; however, the failure rate is relatively high with 34%–74% of patients with CP requiring secondary hip surgery. Using temporary medial hemiepiphysiodesis of the proximal femur (TMH-PF), the morphology of the hip can be changed. This technique aims to reduce further hip migration and the need for secondary surgical management. Further research is necessary to determine the benefit of TMH-PF in addition to adductor-psoas tenotomy. The hypothesis of this study is that TMH-PF combined with adductor-psoas release decreases the chance of progressive hip migration and the need for secondary hip surgery, compared with adductor-psoas release alone.Methods and analysisThe GUIDANCE study is an open-label multicentre randomised controlled trial. Patients with CP aged between 2 and 8 years, with spastic CP—Gross Motor Function Classification System IV or V, hip abduction ≤40° and hip migration of 30%–50% can be included in this trial. They will be randomised into a control arm (adductor-psoas tenotomy) or an intervention arm (adductor-psoas tenotomy+TMH PH). The primary outcome will be treatment failure at 5-year follow-up. At 2-year follow-up a preliminary analysis will be performed. Secondary outcomes will be differences in patient-reported outcome measures (CPCHILD and CPG pain score), range of motion, radiological measurements including head shaft angle and hip migration percentage and three-dimensional (3D) morphological changes to the proximal femur. Furthermore, an analysis will be performed to identify predictors for treatment failure in both treatment arms.Ethics and disseminationThe GUIDANCE study should provide evidence on the effectiveness of TMH-PF in addition to adductor-psoas tenotomy in children with CP with early hip migration. If beneficial, larger hip reconstructive procedures can be delayed or prevented, providing a distinct benefit for these vulnerable children. The study’s strengths lie in its methodological framework, incorporating randomised allocation and intervention assessment. The main limitation is the inability to blind the treating physician or the researcher for the treatment arm the participant is allocated to. The results of the GUIDANCE study will be presented at scientific meetings and published in international peer-reviewed journals. The aim is to publish the results at 2 years follow-up and 5 years follow-up and to publish the results of the analysis on the 3D morphology of the hip after TMH-PF. Individual de-identified participant data that underlie the results from the GUIDANCE study and the study protocol will be shared if requested.Trial registration numberClinical Trial Registry number: NCT06118736. Registered on 3 November 2023.
Journal Article
Needle tenotomy with PRP versus lidocaine in epicondylopathy: clinical and ultrasonographic outcomes over twenty months
by
Grandes, Gonzalo
,
Bully, Paola
,
Iglesias, Gotzon
in
Adjuvants
,
Clinical outcomes
,
Disabilities
2019
ObjectiveTo investigate whether pathological changes in elbow epicondylopathy, as assessed by conventional ultrasonography and clinical outcomes, could be modified following tenotomy with platelet-rich plasma (PRP) versus tenotomy with lidocaine.MethodsThis prospective sub-study was part of a patient- and assessor-blinded, superiority-type, randomized, lidocaine-controlled trial that was performed in a tertiary hospital to assess the effectiveness of PRP versus lidocaine as tenotomy adjuvants in patients with epicondylopathy. Patients were followed after two sessions of tenotomy with either PRP or lidocaine adjuvants (4 ml) within a 2-week interval. Tendon thickness, echotexture, and neovascularization were assessed as secondary outcome measurements at baseline and at 3, 6, 12, and 20 months after treatment, and correlations with clinical outcomes were examined.ResultsTwenty months after treatment, tenotomy induced changes in tendon structure, thickness (± = 0.0006), vascularity (p < 0.0001), and echotexture (p < 0.0001). In Disabilities of the Arm, Shoulder and Hand (DASH-E) and pain (VAS-P) scores, 80.85% and 90.91% of patients showed a meaningful clinical improvement, respectively, without differences between PRP and lidocaine. There were significant differences in between-group changes in vascularity over time, p = 0.037 and p = 0.049 in the unadjusted and adjusted models, respectively. There was no relationship between pain or function and sonographic entities at the various time points.ConclusionsTwo successive needle tenotomies induced structural changes in recalcitrant epicondylopathy, with PRP displaying more vascularization and increased thickness over time compared to lidocaine. PRP compared with lidocaine did not result in improved function or decreased pain over 20 months.
Journal Article
Arthroscopic Biceps Tenodesis Compared With Repair of Isolated Type II SLAP Lesions in Patients Older Than 35 Years
by
Burkhart, Stephen S.
,
Lädermann, Alexandre
,
Denard, Patrick J.
in
Adult
,
Arthroscopy - methods
,
Cysts
2014
This study compared arthroscopic biceps tenodesis with biceps repair for isolated type II superior labrum anterior and posterior (SLAP) lesions in patients older than 35 years. The authors identified isolated type II SLAP lesions that were surgically managed over a 5-year period. Minimum 2-year follow-up data were available for 22 patients who underwent biceps repair (repair group) and for 15 patients who underwent a primary biceps tenodesis (tenodesis group). Mean age at surgery was 45.2±5.5 years in the repair group and 52.0±8.0 years in the tenodesis group. In the repair group, functional outcome improved from baseline to final follow-up using the American Shoulder and Elbow Surgeons (ASES) (47.5 to 87.4, respectively; P <.0001) and University of California, Los Angeles (UCLA) scores (18.5 to 31.2, respectively; P <.0001). In the tenodesis group, similar findings were observed for the ASES (43.4 to 89.9, respectively; P <.0001) and UCLA scores (19.0 to 32.7, respectively; P <.0001). No difference was found in functional outcome between the groups. Full range of motion recovery was delayed by approximately 3 months in the repair group compared with the tenodesis group ( P =.0631). Two patients in the repair group required a secondary capsular release. Seventy-seven percent of patients in the repair group and 100% of patients in the tenodesis group were satisfied and returned to normal activity ( P =.0673). In the current study, individuals older than 35 years with an isolated type II SLAP lesion had a shorter postoperative recovery, a more predictable functional outcome, and a higher rate of satisfaction and return to activity with a biceps tenodesis compared with a biceps repair. Based on these observations, biceps tenodesis is preferable to biceps repair for isolated type II SLAP lesions in nonoverhead athletes older than 35 years.
Journal Article
Platelet-rich plasma versus lidocaine as tenotomy adjuvants in people with elbow epicondylopathy: a randomized controlled trial
by
Areizaga, Luis
,
Atilano, Leire
,
Grandes, Gonzalo
in
Adjuvants
,
Adult
,
Anesthetics, Local - administration & dosage
2019
Objectives
To determine the efficacy of platelet-rich plasma (PRP) compared to lidocaine as a tenotomy adjuvant for people with elbow tendinopathy.
Methods
Our study was a parallel-group, double-blind, randomized trial involving 71 patients with recalcitrant elbow tendinopathy who received two sessions of ultrasound-guided tenotomy with either PRP or lidocaine in a tertiary public hospital. The primary end point was the percentage of patients with an improvement exceeding 25% reduction in disability (Spanish version of the Disabilities of the Arm, Shoulder and Hand questionnaires–DASH-E) at 6 and 12 months; the secondary outcome was the percentage of patients exceeding 25% reduction in pain (VAS-P).
Results
There was no evidence of significant differences in the proportion of patients who experienced clinically relevant improvements. After 6 months, 18 patients (78.59%) in the lidocaine group and 19 patients (73.08%) in the PRP group showed improved function above 25% (unadjusted odds ratio, 0.90; 95% confidence interval [CI], 0.90 (0.17 to 4.60)); 21 patients (72.21%) in the lidocaine group versus 22 patients (84.62%) in the PRP group achieved more than 25% pain reduction (unadjusted odds ratio, 0.48; 95% CI, 0.10 to 2.37). After 12 months, 17 patients (70.83%) in the lidocaine group versus 19 patients (76%) in the PRP group had improved function (unadjusted odds ratio, 0.71; 95% CI, 0.13 to 3.84), and 19 patients (76%) in the lidocaine group versus 20 patients (90.91%) in the PRP group had improved pain above 25% (unadjusted odds ratio, 0.35; 95% CI, 0.06 to 2.51). Hypercholesterolemia and baseline vascularization influenced outcomes. There were no differences between groups in the adjusted odds ratios.
Conclusion
PRP results in similar improvements to those obtained with lidocaine. Selecting patients according to their pretreatment status can improve treatment efficacy.
Trial registration
NCT01945528
, EudraCT 2013-000478-32. Registered 18 August 2013, enrolment of the first participant 10 March 2014
Journal Article
Effect of flexor tendon tenotomy of the diabetic hammertoe on plantar pressure: a randomized controlled trial
by
Rasmussen, Anne
,
Frimodt-Møller, Marie
,
Engberg, Susanne
in
Aged
,
Clinical care/Education/Nutrition
,
Debridement
2024
IntroductionThe aim of this study was to evaluate the effects of flexor tendon tenotomy treatment of the diabetic hammertoe deformity on plantar pressure.Research design and methodsThe study was a substudy including participants from a randomized study on tenotomy treatment of diabetic hammertoes. This study was conducted between December 20, 2019 and June 22, 2021. Participants were randomized to tenotomy and standard non-surgical treatment or standard non-surgical treatment alone. Barefoot plantar pressure measurement was performed pre-intervention and 3 months post-intervention. Primary outcome was change in peak plantar pressure post tenotomy treatment.ResultsOf the 95 participants screened in the original study, 45 (57.8% male) were included andcompleted this substudy. Of the 45 participants, 22 were randomized to intervention. The average age of participants was 65.6 ((SD±) 9.5) years and 30 (66.7%) had type 2 diabetes.The average peak plantar pressure (PPP) in toe regions of the participants in the intervention group was significantly (p<0.0001) reduced from 205.6 kPa ((Q1–Q3) 152.0–289.1) pre-intervention to 61.3 kPa (39.1–100.5) post-intervention. The average reduction in PPP of toe regions for participants in the intervention group (−145.3 kPa (−225.9 to −56.2)) was significantly (p=0.00017) higher than what was observed for participants in the control group (−1.6 kPa (−30.2 to 27.9)).ConclusionThis study found that tenotomies of the diabetic hammertoe reduces plantar pressure affecting the treated toes. This likely explains the positive effects of tenotomy treatment on diabetic foot ulcers.
Journal Article
Non-inferiority and cost-effectiveness trial of isolated biceps tenotomy versus tenotomy with rotator cuff repair in patients with stage 2–3 Goutallier fatty degenerative cuff lesions (TenCuRe study): protocol of a multicentre randomised controlled trial
2020
IntroductionFor patients who are diagnosed with lesions of the rotator cuff that present advanced levels of fatty degeneration, arthroscopic repair of the rotator cuff remains controversial. This controversy can be attributed to the frequently reported high failure rate of the tendon fixation and the fact that it remains unclear why repair for these tears results in significant clinical improvement independent of the occurrence of such a re-tear. Recent publications have reported comparable clinical improvements when merely a tenotomy of the long head of the biceps tendon was performed and the rotator cuff tear was left untreated. These observations raise questions on the value of performing the more extensive cuff repairs in degenerative cuff tears. Even more, rehabilitation after an isolated tenotomy is much less cumbersome as compared with rehabilitation after rotator cuff repair and, therefore, might result in improved patient satisfaction. The goal of this trial is to study function and quality-of-life of patients undergoing arthroscopic biceps tenotomy with or without an additional cuff repair and to include an economic evaluation.Methods and analysisThis multicentre randomised controlled non-inferiority trial, including an economic evaluation, is designed to compare the short-term and long-term outcome of patients who underwent an arthroscopic tenotomy of the long head of the biceps tendon with or without a cuff repair. We will include 172 patients with stage 2–3 Goutallier fatty infiltration cuff tears and with clinical symptoms of biceps pathology. Primary outcome is the rotator cuff specific quality-of-life (Western Ontario Rotator Cuff index) on the short term (6 months postoperatively). Secondary outcomes are quality-of-life 1, 2 and 5 year postoperatively and function (Constant-Murley score, glenohumeral range of motion), recovery status, pain (visual analogue scale), economic evaluation, satisfaction of treatment on the short-term and long-term and re-tear rate at 6 months determined with an ultrasound.Ethics and disseminationThis trial has been approved by the Medical Research Ethics Committees United (MEC-U), Nieuwegein, the Netherlands (NL54313.100.15) and will be performed in accordance with the Declaration of Helsinki with the Medical Research Involving Human Subjects Act (WMO). The results of this study will be reported in peer-reviewed journals and at (inter)national conferences. Furthermore, we will share our findings with the appropriate guideline committees.Trial registration numberThe Dutch Trial Registry (NL4010).
Journal Article
Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol
by
Gurnani, Navin
,
van Deurzen, Derek Friedrich Petrus
,
Verweij, Lukas Pieter Eduard
in
Arthroscopy
,
Elbow Joint - physiology
,
Epidemiology
2016
Background
Optimal treatment of the diseased long head of the biceps (LHB) tendon during rotator cuff repair remains a topic of debate: tenotomy or tenodesis. A recent meta analysis revealed no difference in strength or functional outcome between treatments. The included studies varied in methodological quality, and only two were randomized controlled trials (RCTs). As strong evidence in favor of either tenotomy or tenodesis is still lacking, we designed this randomized controlled trial to compare functional outcomes after tenotomy and tenodesis when performed in adjunct to arthroscopic rotator cuff repair.
Methods
Patients older than 50 years with a supraspinatus and/or infraspinatus tendon rupture sized smaller than 3 cm, who are encountered with LHB pathology, will be randomized to either LHB tenotomy or LHB tenodesis. Clinical and patient-reported data will be collected pre-operatively, 6 weeks, 3 months and 1 year after surgery.
Primary outcome is overall shoulder function evaluated with the Constant score at 1 year after surgery. As additional measures of shoulder function, two patient reported outcomes (the Dutch Oxford Shoulder Test and the Disabilities of the Arm Shoulder and Hand questionnaire) will be assessed. Other evaluations include cosmetic appearance evaluated by the “Popeye” deformity, elbow flexion strength, arm cramping pain, MRI-based location of the biceps tendon, quality of life, and duration of surgery. To detect non-inferiority with a one-sided, two-sample t-test with 80 % power and a significance level (alpha) of 0.025, the required sample size is 98 patients.
Discussion
Treatment of LHB tendon lesions is performed differently around the world and meta analyses do not provide conclusive evidence in favor of one of these treatments. This study will strengthen evidence on the risks and benefits of LHB tenotomy and tenodesis in adjunct to a rotator cuff repair, which is important for managing patient expectations.
Trial registration
Dutch Trial Register (
NTR3255
) January 12, 2012, ClinicalTrials.gov (ID
NCT02655848
) January 14, 2016, retrospectively registered.
Journal Article
Surgical offloading procedures for diabetic foot ulcers compared to best non-surgical treatment: a study protocol for a randomized controlled trial
2018
Background
Diabetic foot ulcers are frequently related to elevated pressure under a bony prominence. Conservative treatment includes offloading with orthopaedic shoes and custom made orthotics or plaster casts. While casting in plaster is usually effective in achieving primary closure of foot ulcers, recurrence rates are high. Minimally invasive surgical offloading that includes correction of foot deformities has good short and long term results. The surgery alleviates the pressure under the bony prominence, thus enabling prompt ulcer healing, negating the patient’s dependence on expensive shoes and orthotics, with a lower chance of recurrence. The purpose of this protocol is to compare offloading surgery (percutaneous flexor tenotomy, mini-invasive floating metatarsal osteotomy or Keller arthroplasty) to non-surgical treatment for patients with diabetic foot ulcers in a semi-crossover designed RCT.
Methods
One hundred patients with diabetic neuropathy related foot ulcers (tip of toe ulcers, ulcers under metatarsal heads and ulcers under the hallux interphalangeal joint) will be randomized (2:3) to a surgical offloading procedure or best available non-surgical treatment. Group 1 (surgery) will have surgery within 1 week. Group 2 (controls) will be prescribed an offloading cast applied for up to 12 weeks (based on clinical considerations). Following successful offloading treatment (ulcer closure with complete epithelization) patients will be prescribed orthopaedic shoes and custom made orthotics. If offloading by cast for at least 6 weeks fails, or the ulcer recurs, patients will be offered surgical offloading. Follow-up will take place till 2 years following randomization. Outcome criteria will be time to healing of the primary ulcer (complete epithelization), time to healing of surgical wound, recurrence of ulcer, time to recurrence and complications.
Discussion
The high recurrence rate of foot ulcers and their dire consequences justify attempts to find better solutions than the non-surgical options available at present. To promote surgery, RCT level evidence of efficacy is necessary.
Trial registration
Israel MOH_2017–08-10_000719. NIH:
NCT03414216
.
Journal Article