BackgroundTinnitus represents a relatively common condition in the global population accompanied by various comorbidities and severe burden in many cases. Nevertheless, there is currently no general treatment or cure, presumable due to the heterogeneity of tinnitus with its wide variety of etiologies and tinnitus phenotypes. Hence, most treatment studies merely demonstrated improvement in a subgroup of tinnitus patients. The majority of studies are characterized by small sample sizes, unstandardized treatments and assessments, or applications of interventions targeting only a single organ level. Combinatory treatment approaches, potentially targeting multiple systems as well as treatment personalization, might provide remedy and enhance treatment responses. The aim of the present study is to systematically examine established tinnitus therapies both alone and in combination in a large sample of tinnitus patients. Further, it wants to provide the basis for personalized treatment approaches by evaluating a specific decision support system developed as part of an EU-funded collaborative project (Unification of treatments and interventions for tinnitus patients; UNITI project).Methods/study designThis is a multi-center parallel-arm randomized clinical trial conducted at five different clinical sites over the EU. The effect of four different tinnitus therapy approaches (sound therapy, structured counseling, hearing aids, cognitive behavioral therapy) applied over a time period of 12 weeks as a single or rather a combinatory treatment in a total number of 500 chronic tinnitus patients will be investigated. Assessments and interventions are harmonized over the involved clinical sites. The primary outcome measure focuses on the domain tinnitus distress assessed via the Tinnitus Handicap Inventory.DiscussionResults and conclusions from the current study might not only provide an essential contribution to combinatory and personalized treatment approaches in tinnitus but could also provide more profound insights in the heterogeneity of tinnitus, representing an important step towards a cure for tinnitus.Trial registrationClinicalTrials.gov NCT04663828. Registered on 11 December 2020.

BackgroundThe purpose of the study is to evaluate clinical and radiological outcomes in those patients with femoral head fracture, treated with open reduction and internal fixation through Gibson approach and Ganz flip trochanter osteotomy. The treatment of Pipkin fractures is very challenging, especially for small trauma centers, because of the unusual fracture patterns and high-level surgical skills required.Case presentationBetween 2017 and 2020, nine cases of Pipkin fractures came to the Emergency Department at the Trauma Center of our Hospital in Rome. Inclusion criteria were the diagnosis of femoral head fracture, the open reduction and internal fixation as surgical choice and at least 24 months follow-up. Patients older than 65 years and those treated through total hip replacement or combined hip procedure (CHP) were excluded. Thus, five patients were included in our case series. The clinical outcome was evaluated according to Western Ontario and McMaster Universities Arthritis Index, Vail Hip score, modified Harris Hip score and Merle D’Aubignè Postel score. Radiographic assessment was scored according to Epstein-Thompson classification and heterotopic ossification was assessed through Brooker classification. The mean follow-up was 24 months (range 12-24). Average modified Harris Hip score was 92.1 points (range 75.9–100), and the average Vail score was 81.8 (range 55-95). WOMAC score was assessed in three different subscales, pain (A), stiffness (B) and physical condition (C), with the following results: 1.4 A (range 0-7), 1.2 B (range 0-6) and 6.4 C (range 0-22). Merle d’Aubignè Postel score resulted excellent for four patients and good for one patient. According to Epstein-Thompson score of the radiological outcome, four patients showed a good result and one a fair result. No mechanical or infective complications occurred in the five patients.ConclusionsGibson’s approach and surgical hip dislocation through Ganz trochanteric flip osteotomy allow a good exposure of the femoral head and acetabulum, giving us the possibility to perform an anatomical reduction of the fracture. In our case series, satisfactory clinical and radiological short-term results were obtained without significant complications.

BackgroundTonsillar surgery has been used for decades to treat recurrent and chronic tonsillitis in adults. Recurrent and chronic tonsillitis result in disturbing symptoms, treatment costs, sick leave, and impaired quality of life (QoL). Theoretically, removing all or part of the altered pathological palatal lymphoid tissue alleviates the symptoms and enhances the QoL. Whether this is true with total or partial tonsillar resection (tonsillectomy (TE) and tonsillotomy (TT), respectively) has not been reported in a randomised trial yet.MethodsWe conduct a multicentre, partly blinded, randomised, 6-month, parallel-group clinical study including 285 adult participants referred to surgical treatment for chronic or recurrent tonsillitis. The participants will either have TE, TT or watchful waiting (WW). The primary outcome will be the difference between the mean disease-specific Tonsillectomy Outcome Inventory-14 (QoL questionnaire) scores at 6 months. Comparison is made firstly between the combined TE+TT and WW groups (superiority analysis), and secondly between the TE and TT groups (non-inferiority analysis).DiscussionThis study will add significant new information to the effects and harms of TE and TT procedures in the treatment of adults with chronic or recurrent tonsillitis.Trial registrationClinicalTrials.gov: NCT04657549