Assessing a 12-month course of oral alendronate for adults with avascular necrosis of the hip: MANTIS RCT with internal pilot.

BACKGROUND: People with avascular necrosis of the hip have very limited treatment options currently available to stop the progression of this disease; this often results in the need for a hip replacement. There is some weak evidence that a class of drugs called bisphosphonates may delay the course of the disease, and this trial was commissioned and set up to provide robust evidence regarding the use of bisphosphonates in adults aged ≥ 18 years with this condition. OBJECTIVES: The aim of the Managing Avascular Necrosis Treatments: an Interventional Study ( MANTIS ) trial was to evaluate the clinical effectiveness and cost-effectiveness of a 12-month course of alendronate in the treatment of avascular necrosis. DESIGN: This was a 66-month, definitive, multisite, two-arm, parallel-group, placebo-controlled, double-blind, randomised controlled trial, with an internal pilot phase. SETTING: Eight secondary care NHS hospitals across the UK. PARTICIPANTS: Planned trial size - 280 adult patients with avascular necrosis. INTERVENTION: Participants in the intervention group received 70 mg of alendronate (an oral bisphosphonate) weekly for 12 months. MAIN OUTCOMES: The main outcomes were Oxford Hip Score at 12 months (short-term outcome) and the time to decision that a hip replacement is required at 36 months (long-term outcome). RESULTS: Twenty-one patients were recruited and randomised to receive either the intervention drug, alendronate, or a placebo-matched tablet. LIMITATIONS: This trial was principally limited by low disease prevalence. Other limitations included the late disease stage at which participants were identified and the rapid progression of the disease. FUTURE WORK: This trial was limited by a low recruitment rate. Avascular necrosis of the hip should be treated as a rare disease. Future trials would need to recruit many more sites and recruit over a longer time period, and, for this reason, a registry may provide a more effective means of collecting data pertaining to this disease. CONCLUSIONS: The MANTIS trial was terminated at the end of the pilot phase, because it did not meet its go/no-go criteria. The main issue was a poor recruitment rate, owing to a lower than expected disease prevalence and difficulties in identifying the condition at a sufficiently early stage. Those patients who were identified and screened either were too advanced in their disease progression or were already taking medication. We would not recommend that a short-term interventional study is conducted on this condition until its prevalence, geographic foci and natural history and better understood. The difficulty of acquiring this understanding is likely to be a barrier in most health-care markets. One means of developing this understanding would be the introduction of a database/registry for patients suffering from avascular necrosis of the hip. TRIAL REGISTRATION: The trial is registered as ISRCTN14015902. FUNDING: This project was funded by the National Institute for Health and Care Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 43. See the NIHR Journals Library website for further project information.

WHAT WAS THE QUESTION?: The Managing Avascular Necrosis Treatments: an Interventional Study ( MANTIS ) trial was designed to compare ways of treating patients with avascular necrosis who are seeking to slow down the deterioration of their condition. Alendronate is a drug routinely available across the NHS in both tablet and injection form, and doctors and scientists believe that it might prevent ongoing hip deterioration and result in fewer patients requiring a total hip replacement. WHAT DID WE DO?: This trial attempted to compare alendronate taken as a tablet with an identical-looking tablet that did not contain any of the drug (a placebo) to find out if alendronate reduced the number of patients requiring a hip replacement and having pain (compared with patients who did not get alendronate). WHAT DID WE FIND?: Patients were willing to participate in the trial but we were able to recruit only a small number to the study. The main reason for this was difficulty in identifying potentially suitable patients and approaching them at the right point in their medical care. This was more challenging than anticipated, particularly because the NHS sites and professionals that patients with this condition seek out are extremely variable in the UK. It was also difficult to locate and identify patients with the condition at an early enough stage, and before they had already started taking the drug. WHAT DOES THIS MEAN?: More information on patients with this rare condition, such as NHS referral pathways, and an understanding of how the condition progresses may help to improve our understanding of this patient group. This information could also help us determine whether or not there is scope to carry out the study in a different way that might enable these patients to be more easily identified.

Dual Mobility hip replacement in hip fractures offer functional equivalence and a stability advantage - A case-controlled study.

BACKGROUND: Hip fracture is a common and serious injury in the elderly. Hip arthroplasty is the most frequently performed procedure for patients with an  intracapsular hip fracture. The majority of national guidelines recommend total hip arthroplasty (THA) for more active patients. Literature indicates significant stability advantages for dual mobility (DM) acetabular components in non-emergent scenarios. Evidence supporting the use of DM in hip fracture patients is limited. AIM: We set out to ascertain if DM implants offer stability and/or functional advantages over standard THA in patients with hip fracture. METHODS: We utilised our local National Hip Fracture Database to identify all patients undergoing either a standard or DM THA for hip fracture (n=477) We matched cohorts based on age, AMTS, mobility status pre-operatively, gender, ASA and source of admission. Our primary outcome of interest was functional status using the oxford hip score (OHS). Secondary outcome measures included  dislocation, fracture and deep infection requiring further surgery. RESULTS: 62 patient pairs were available for this study. Mean OHS for DM THA was 41.5 and for standard THA this was 42.7 (p=0.58). There were 4 dislocations in the standard THA group and 0 with DM THA. No difference was seen with infection or peri-prosthetic fracture. CONCLUSION: This study demonstrates functional equivalence between DM and standard THA. In addition it shows a trend towards less dislocation with DM THA. Cost savings from less instability may outweigh initial prosthesis costs. This study suggests a suitably powered RCT using instability as the primary outcome measure is indicated.

Orthopaedic surgery in a time of COVID-19: Using a low prevalence COVID-19 trauma surgery model to guide a safe return to elective surgery.

AIMS: Elective surgery has been severely curtailed as a result of the COVID-19 pandemic. There is little evidence to guide surgeons in assessing what processes should be put in place to restart elective surgery safely in a time of endemic COVID-19 in the community. METHODS: We used data from a stand-alone hospital admitting and operating on 91 trauma patients. All patients were screened on admission and 100% of patients have been followed-up after discharge to assess outcome. RESULTS: Overall, 87 (96%) patients remained symptom-free and recovered well following surgery. Four (4%) patients developed symptoms of COVID-19, with polymerase chain reaction ribonucleiuc acid (PCR-RNA) testing confirming infection. CONCLUSION: Based on our findings, we propose that if careful cohorting and screening is carried out in a stand-alone cold operating site, it is reasonable to resume elective operating, in a time of endemic but low community prevalence of SAR-Cov2.Cite this article: Bone Joint Open 2020;1-6:229-235.

The effect of isotonic saline on the strength of bone cement during the polymerisation period.

It is common practice to irrigate the wound in hip and knee replacement surgery during the working and setting phases of cement polymerisation. We sought to establish whether the addition of normal saline during the various stages of polymerisation would affect bone cement strength. Cement specimens were moulded to the dimensions defined in ISO 5833: 2002 and tested in an electro-mechanical test machine with a calibrated 50 kN load cell at a compression rate of 24 mm/min. The results suggest that the compressive strength of bone cement is not affected by the presence of saline following the initiation of polymerisation. However, saline added to the mix prior to the initiation of polymerisation increased its porosity and significantly decreased its strength. This may explain why vacuum mixing is important as it removes water vapour.

The effect of obesity on the outcome of hip and knee arthroplasty.

The aim of this study was to evaluate the outcome of joint arthroplasty in obese and non-obese patients. We reviewed 2,026 consecutive primary total hip and 535 primary total knee arthroplasties performed for osteoarthritis. Patients were separated into two groups according to their body mass index (BMI): non-obese (BMI < 30) and obese (BMI ≥ 30). Their survivorships were compared. Case controlled studies were performed with 134 hip and 50 knee arthroplasties in obese patients. Each was matched individually with a control and their outcome compared. Log rank tests for equality of survival showed no difference in the survival for hip and knee arthroplasty at 11 and ten years, respectively. The obese group had significantly lower postoperative hip and knee scores at latest follow-up, especially in the range of motion. Overall patient satisfaction scores were comparable. There were no significant differences in the radiographic analysis of both hip and knee implants. Revision was used as an end point for the survival analysis. Functional scores (Harris hip score and Hospital for Special Surgery knee score), satisfaction for surgery and radiographic features were used as outcome measures for comparison. The mid-term survival of total hip and knee arthroplasty is not adversely affected by obesity. Despite lower clinical scores, the obese patients were satisfied with the results of their surgery and have an equivalent mid-term survival rate. It would be unreasonable to deny patients arthroplasty surgery purely on the basis of a BMI indicating obesity.

Return to training and playing after posterior ankle arthroscopy for posterior impingement in elite professional soccer.

BACKGROUND: Posterior ankle impingement syndrome (PAIS) was first described in ballet dancers but is increasingly being diagnosed in other sports. Operative treatment may be indicated when nonoperative measures have failed. Traditionally, operative treatment has involved an open approach; more recently, posterior ankle arthroscopy has been employed. PURPOSE: This study was conducted to describe the factors that influence return to play in professional athletes after posterior ankle arthroscopy for posterior ankle impingement syndrome. STUDY DESIGN: Case series; Level of evidence 4. METHODS: A consecutive series of 28 elite professional soccer players who had clinically and radiologically diagnosed posterior ankle impingement syndrome that failed to respond to nonoperative treatment underwent posterior ankle arthroscopy for bony or soft tissue posterior ankle impingement syndrome over 5 years. RESULTS: Of the 28 players, 27 were available for follow-up. Five had a diagnosis of soft tissue impingement and underwent debridement with flexor hallucis longus release, 13 had a symptomatic os trigonum that was excised arthroscopically, and 9 had removal of a bony avulsion fragment from the posterior ankle ligament complex. The mean length of time to return to training postoperatively was 34 days and return to playing was 41 days (range, 29-72 days). The duration of symptoms before surgery and excision of bony impingement were significantly correlated with the time to return to training and playing. There were no major complications and no reoperations at an average of 23 months of follow-up (range, 15-49 months). CONCLUSION: Posterior ankle arthroscopy is safe and effective in the treatment of posterior ankle impingement syndrome in the elite soccer player, with return to training expected at an average of 5 weeks.

Long term results of cementless total hip replacement for reversal of hip ankylosis.

Fifteen patients (16 hips) with an ankylosed hip joint for a mean of 36 years (3.5 to 65), had their hips converted to a cementless Total Hip Replacement (THR). They were followed-up for a median of 10.75 years (5.0 to 19) with none lost to follow-up. All patients showed improved mobility and function post-operatively. The Harris Hip Score improved from 70 (SEM 3.4) to 83 post-operatively (SEM 4.4), which was statistically significant (p < 0.05). There was one acetabular cup revision at 5 years post implantation for aseptic loosening. All other femoral and acetabular components remained clinically and radiographically well fixed. We conclude that a previously ankylosed hip can be effectively converted to a cementless total hip replacement with good long term results.