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.

INTRODUCTION: For 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 ANALYSIS: This 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 DISSEMINATION: This 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 NUMBER: The Dutch Trial Registry (NL4010).

Treatment of Massive Irreparable Rotator Cuff Tears: A Cost-effectiveness Analysis.

Massive irreparable rotator cuff tears cause significant shoulder pain and dysfunction. Physical therapy (PT), arthroscopic debridement with biceps tenotomy (AD-BT), and hemiarthroplasty (HA) are treatments shown to reduce pain and improve quality of life. Reverse total shoulder arthroplasty (RTSA) is a newer surgical treatment option that may offer improved function. A cost-effectiveness analysis of these interventions has never been performed, and no head-to-head comparative effectiveness trials currently exist. A Markov decision analytic model was used to compare RTSA, HA, AD-BT, and PT as treatments for elderly patients with massive irreparable rotator cuff tears. Probabilities for complications, perioperative death, conversion procedures, and reoperations were derived from the literature, and costs were determined by average Medicare reimbursement rates from 2011. Reverse total shoulder arthroplasty yielded the most quality-adjusted life years (QALY) with 7.69, but greater benefits came at higher costs compared with other treatments. Sensitivity analyses showed that PT was the most cost-effective intervention at a health utility of 0.75 or greater (QALY 7.35). The health utility of RTSA was 0.72 or less (QALY 7.48) or RTSA probability of no complications was 0.83 or less (QALY 7.48 at cost of $23,830). Reverse total shoulder arthroplasty yielded benefits at a cost considered good value for money compared with other treatments. Reverse total shoulder arthroplasty is the preferred and most cost-effective treatment option for elderly patients with massive irreparable rotator cuff tears. For patients seeking pain relief without functional gains, AD-BT can be considered a cost-effective and cheaper alternative. The cost-effectiveness analysis approach can help guide clinical practice as well as the policies of health care systems and insurers. [Orthopedics. 2017; 40(1):e65-e76.].

Costs and benefits of routine histopathological examination of hammertoe specimens.

BACKGROUND: The purpose of this study was to evaluate the cost and benefit of routinely submitting hammertoe specimens for histopathological examination. We hypothesized that such examination rarely shows a new diagnosis and seldom alters postoperative care. MATERIALS AND METHODS: Three hundred and fourteen proximal interphalangeal (PIP) joint and 37 extensor tendon specimens from 187 consecutive hammertoe correction surgeries were submitted by 2 surgeons for histopathological examination between January 2009 and December 2011. Each patient's chart was reviewed to determine whether the histopathological examination revealed a diagnosis other than degenerative joint or degenerative tendon and whether subsequent patient management was altered. The total reimbursements for professional charges were calculated using the average reimbursement from common insurance providers for two Current Procedural Terminology (CPT) codes: 88304 (soft tissue examination) and 88311 (decalcification). RESULTS: Almost all of the specimens were diagnosed as degenerative: 97.5% (307/314) of the PIP specimens and all (37/37) of the tendon specimens. Seven PIP specimens (2.2%, 7/314) from 5 patients (2.7%, 5/187) and no tendon specimens had other diagnoses. These diagnoses were rheumatoid arthritis (5/314, 1.6%), osteomyelitis (1/314, 0.3%), and pigmented villonodular synovitis (PVNS) (1/314, 0.3%). Only the PVNS was a new diagnosis. A total of $56,750 was spent to determine 1 new diagnosis. CONCLUSION: The routine submission of hammertoe specimens for pathological evaluation was not cost-efficient. Our analysis showed that new diagnoses were rarely found and patient management was not affected.

From cutting to casting: impact and initial barriers to the Ponseti method of clubfoot treatment in China.

In 2005, a nationwide clubfoot treatment program focused on the Ponseti method -an effective, affordable and minimally-invasive method- was initiated in China. The purpose of this study was to evaluate and identify barriers to the program. A qualitative study (rapid ethnographic study) was conducted using semi-structured interviews of 44 physicians who attended four of the 10 Ponseti training workshops, focus groups with parents of children with clubfoot, and observation. Several barriers to the Ponseti method are quite unique due to China's size, socio-economics, culture, politics, and healthcare systems. The barriers were classified into seven themes: (i) physician education, (ii) caregiver compliance, (iii) culture, (iv) public awareness, (v) poverty, (vi) financial constraints for physicians/hospitals, and (vii) challenges of the treatment process. A number of suggestions that could be helpful in reducing or eliminating the effects of these barriers were also identified: (i) pamphlets explaining clubfoot and treatment for caregivers, (ii) directories of Ponseti providers, (iii) funding/financial support, and (iv) improving public awareness. The information from this study provides healthcare planners with knowledge to assist in meeting the needs of the population and continued implementation of effective and culturally appropriate awareness and treatment programs for clubfoot throughout China.

Ponseti clubfoot management: changing surgical trends in Nigeria.

BACKGROUND: Congenital clubfoot treatment continues to be controversial particularly in a resource-constrained country. Comparative evaluation of clubfoot surgery with Ponseti methods has not been reported in West Africa. OBJECTIVES: To determine the effects of Ponseti techniques on clubfoot surgery frequency and patterns in Nigeria. METHODS: This was a prospective hospital-based intention-to-treat comparative study of clubfoot managed with Ponseti methods (PCG) and extensive soft tissue surgery (NPCG). The first step was a nonselective double-blind randomization of clubfoot patients into two groups using Excel software in a university teaching hospital setting. The control group was the NPCG patients. The patients' parents gave informed consent, and the medical research and ethics board approved the study protocol. Biodata was gathered, clubfoot patterns were analyzed, Dimeglio-Bensahel scoring was done, the number of casts applied was tallied, and patterns of surgeries were documented. The cost of care, recurrence and outcomes were evaluated. Kruskal-Wallis analysis and Mann-Whitney U technique were used, and an alpha error of < 0.05 at a CI of 95% were taken to be significant. RESULTS: We randomized 153 clubfeet (in 105 clubfoot patients) into two treatment groups. Fifty NPCG patients (36.2%) underwent manipulation and extensive soft tissue surgery and 55 PCG patients (39.9%) were treated with Ponseti methods. Fifty-two patients of the Ponseti group had no form of surgery (94.5% vs. 32%, p<0.000). Extensive soft tissue surgery was indicated in 17 (34.0%) of the NPCG group, representing 8.9% of the total of 191 major orthopaedic surgeries within the study period. Thirty-five patients (70.0%) from the NPCG group required more than six casts compared to thirteen patients (23.6%) of the PCG (p<0.000). The mean care cost was high within the NPCG when compared to the Ponseti group (48% vs. 14.5%, p<0.000). The Ponseti-treated group had fewer treatment complications (p<0.003), a lower recurrence rate (p<0.000) and satisfactory early outcome (p<0.000). CONCLUSION: Major clubfoot surgery was not commonly indicated among patients treated with the Ponseti method. The Ponseti clubfoot technique has reduced total care costs, cast utilization, clubfoot surgery frequency and has also changed the patterns of surgery performed for clubfoot in Nigeria.