New Techniques are improving Hip Arthroscopy

New Techniques for Capsular Management in Hip Arthroscopy (Orthopedics This Week)
Benjamin Domb, M.D., founder of the American Hip Institute, has worked for years to develop two specific techniques for capsular management in hip arthroscopy; one for the treatment of hip instability and the other for the treatment of femoroacetabular impingement (FAI).
The first involves hip arthroscopy with labral preservation and capsular plication in patients with borderline hip dysplasia. Dr. Domb told OTW, “Atraumatic micro instability, often associated with borderline dysplasia of the hip, is a recognized cause of groin pain and hip pathology. In the past, literature has shown some disastrous outcomes of arthroscopy in the setting of instability or dysplasia. This may be because arthroscopy involved an incision in the capsule, and sometimes removal of part of the capsule, which might compromise one of the static stabilizers of an already unstable hip.
“Almost a decade ago we began working on a technique to tighten the capsule arthroscopically in order to augment the stability of such hips after arthroscopic labral repair or reconstruction. We found that the use of arthroscopic capsular plication had very favorable results in patients with micro instability of the hip. However, this remains a very technical procedure, and if a great plication is not achieved, outcomes may be suboptimal in these patients.
“The intent of the approach is to preserve the capsule AND tighten it to add stability, in order to successfully treat this challenging group of patients.
“We previously published the results of our initial pilot study with 22 patients who had borderline dysplasia and who were treated with arthroscopic labral repair and capsular plication. To our knowledge this is the first report of outcomes of capsular plication in this population. Nonetheless, we needed to observe whether the repair would last, or whether the plicated capsule would stretch back out over time, in order to establish this as an alternative to periacetabular osteotomy (PAO) as an index treatment for borderline dysplasia.
“For that reason, we undertook to evaluate the outcomes of arthroscopic capsular plication and labral repair at minimum five year follow-up. In this study, with 25 hips (24 patients), the center edge angle in all patients was between 18 and 25. It is important to note we have advocated this procedure only in select cases of borderlinedysplasia. In frank dysplasia—broadly speaking, LCEA [lateral center-edge angle]< 18—we advocate combined arthroscopy and PAO. Other factors which may push us toward PAO include ligamentous laxity or femoral deformities such as excess anteversion. We used four different patient reported outcome scores and Visual Analog Pain score; the outcomes were excellent out to five years. Four hips required secondary arthroscopic procedures, but ultimately had successful outcomes (with favorable patient reported outcomes). None of these patients required conversion to arthroplasty.
“A concern was that in the borderline dysplasia group, the arthroscopic capsular plication we devised would lack durability and that over time the lack of bony support would win over the capsular support we provided; so we were pleased to see that the outcomes appeared to be durable at five year follow-up with no conversions to arthroplasty in this group. These favorable mid-term outcomes, and 100% survivorship at minimum five years, have established the mid-term durability of arthroscopic capsular plication as a treatment for borderline dysplasia. We will continue to follow these patients closely, and will be comparing them to those undergoing alternative treatments.”
Dr. Domb’s second technique involves capsular closure after spherical femoroplasty for femoroacetabular impingement (FAI).
“We have come a long way in treating FAI, with hip arthroscopy taking center stage in the care of patients with this condition. In patients who don’t have dysplasia, the capsule is incised and sometimes part of it is removed. The American Hip Institute has long advocated that the capsule ought to be preserved and repaired.
“Our team undertook a comparative matched cohort study with 65 patients who had capsular repair and 65 patients who did not (the capsulotomy was left open). At five years we saw a significant improvement in all patients in both groups. However, in the unrepaired group at two to five years we did see a deterioration in the Harris Hip Scores and in patient satisfaction, while the outcomes were seen to remain equally favorable at five years in the repaired group. There were fewer patients in the repaired group who required conversion to arthroscopy (10.8 in the repaired group versus 18.3 in the unrepaired group).
“There are certainly patients who have severe stiffness or adhesive capsulitis, in whom incision or removal would be therapeutic. But for the majority of patients who do not have that scenario, we would advocate to preserve and repair the capsule. We hypothesized that the capsule is important in the stability of the hip. There are biomechanical studies showing that an unrepaired capsulotomy increases the rotation and translational instability of the hip. Thus we propose to restore the normal stability using capsular repair after treatment of FAI. We previously published two year follow up on this procedure, which demonstrate favorable results, and established safety and feasibility of the technique. This comparative study reveals the potential advantages of capsular preservation and repair in achieving durable outcomes and increased survivorship.
“In summary, we believe that current biomechanical and clinical evidence suggests that the capsule of the hip serves a valuable role. We believe that careful capsular management, with repair or plication as appropriate in the clinical setting, may lead to improved outcomes in patients with micro instability, and more durable outcomes in a majority of hip arthroscopy surgeries. We will continue to evaluate the long-term clinical outcomes, and to work toward making these procedures technically easier for the surgeon.”

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Vibration may improve the skill of the orthopedic surgeon

BETTER SURGERY THROUGH VIBRATION (Orthopedics This Week)
Japanese researchers have created a vibrating device that can be added to surgical tools could improve surgeons’ sensitivity to different shapes and textures inside their patients’ bodies. The engineers, from Hiroshima University, have designed the small vibrating device that can be used right away and does not require additional training. The vibrations—say the researchers—are so subtle that they do not shake the tool.
“We started this work six years ago, trying to enhance human fingertip sensitivity, but in 2012 I had the idea that increased sensitivity could be valuable during minimally invasive surgeries. Typical medical tools obtain information about the patient’s condition. There are very few devices that aim to enhance the doctor’s skill,” said Yuichi Kurita, Ph.D., lead author of the study and associate professor at Hiroshima University, in the August 1, 2016 news release.
“The vibrator, called PZT Actuator, attaches to a surgeon’s favorite surgical tool and vibrates in the surgeon’s palm at a constant rate. The vibrations are so subtle they cannot be sensed. However, this constant, uniform vibration enhances the surgeon’s sensitivity to other, irregular sensations. The natural variations of touching different tissues with a metal tool may normally be too subtle for the surgeon to detect, but the constant vibrations supplied by the PZT Actuator boost the sensation to a noticeable level.”
“Volunteers were blindfolded and asked to use surgical forceps with the PZT Actuator attached to the handle to identify different textures of sandpaper and find a small Styrofoam ball inside a cup filled with silicone. These tests mimic detecting tissue texture and identifying a solid tumor.”
“The results of these tests and other analysis revealed that there is a range of vibration intensity that significantly improves anyone’s sensitivity. The tool does not need to be fine-tuned to each user’s unique sense of touch, meaning the PZT Actuator should be robust and simple to use.”
“Researchers first tested the device through mathematical modeling using calculations of four types [of] neurons and their response to different levels of mechanical stimulation. The mathematical term describing the phenomena of a constant undetectable signal enhancing a simultaneous irregular signal is called the stochastic resonance effect.”
Dr. Kurita told OTW, “Our technique enables surgeons to find very small difference in tactile feeling of body organs. Although our article was done for a medical device of laparoscopic surgery, the basic idea can be applied for any kinds of medical devices that require surgeons nuanced tactile information to use, including orthopedic surgery.”
“The optimal noise to be added depends on the situation. Measuring the actual stimuli given from the surgical forceps during a surgery could be useful to tune the device. The practical design is also needed to keep the functional requirements for a surgical tool, such as:
1) safety,
2) hygiene,
3) not disturbing operations, and
4) ease of use.”

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Researchers find that a Gold-Titanium alloy is the hardest biocompatible metal

GOLD PLUS TITANIUM HARDEST KNOWN METALLIC SUBSTANCE (Orthopedics This Week)
A mixture of titanium and gold turns out to be the hardest known metallic substance that is compatible with living tissues, according to Helen Briggs, writing for the BBC News. This is potentially very good news for makers of hip and knee implants—which often must be replaced after a decade of use because of wear on the device. According to Briggs, Professor Emilia Morosan, Ph.D., of Rice University, Houston, Texas, and her team made the discovery while working on magnets made from titanium and gold.
Because the newly made gold and titanium material needed to be ground into a power to test it for purity, the researchers put it in a diamond-coated porter and pestle. However, the material was so hard that the researchers could not grind it into a powder with the diamond equipment. Morosan said that their Beta-Ti3Au, which they had named it, “showed the highest hardness of all Ti-Au [titanium-gold] alloys and compounds, but also compared to many other engineering alloys.”
Briggs noted that titanium is one of the few metals that human bone is able to grow around, allowing it to be used widely in medicine and dentistry. Morosan said the hardness of the substance, together with its higher biocompatibility, made it a next generation compound for substantively extending the lifetime of dental implants and replacement joints. She added that the gold-titanium alloy is a cubic compound with a particular arrangement of atoms found when metals are combined at high temperatures.

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Intellirod Spine raises funds to win regulatory approvals for wireless measurement of spine rods

INTELLIROD SPINE: $1 MILLION FOR WIRELESS SENSORS (Orthopedics This Week)
Also Read my interview with the CEO…     6 Questions with Ric Navarro, a serial technology innovator in the spine space
Curious about the strain being put on that spine implant? So was Intellirod Spine. The company has just announced that it has raised more than $1 million in equity financing from new and existing investors to do that and more.
As indicated in the July 26, 2016 news release, “Funds will be used to reach key milestones toward the commercialization of the company’s sensor technologies and related lumbar fusion implants.”
According to Intellirod CEO Ric Navarro, “The LOADPRO gives a surgeon new and important information for improving surgical technique. The device becomes an adjunct to the surgeon’s tactile feel for avoiding excessive implant loading.”
Rolando M. Puno, M.D. of Louisville, Kentucky, stated, “With LOADPRO, for the first time, spine surgeons will have an accurate tool to measure and determine the amount of force being applied to the rod implant as spinal deformity is being corrected. Knowing the amount of applied strain will allow spine surgeons to adjust their surgical techniques to achieve the best possible correction of deformity. Furthermore, spine surgeons will be able to avoid the risk of inadvertently applying excessive strain causing fixation failure and/or loss of correction.”
Spine surgeon Michael Steinmetz, M.D. further explained, “The information gained from LOADPRO may allow the surgeon, for the first time, to understand the forces applied to spinal constructs when performing deformity surgery. This information can lead to improved surgical results and patient outcomes.”
Says the news release, “In addition, the company has completed its pre-clinical testing in support of an FDA application for ACCUVISTA, its implantable version of the product. The ACCUVISTA sensor monitors post-operative strain in rods in degenerative disc disease fusion patients, and the company is bullish on its new application for ACCUVISTA in children with scoliosis.”
Asked for detail on the “key milestones” they are aiming for, Ric Navarro told OTW, “We are moving toward FDA approval of LOADPRO, the first clinical use of LOADPRO and CE Mark for LOADPRO.
“Surgeons currently assess forces by feel, this will allow them to quantify forces (by way of rod strain) as they do their correction in kyphotic deformities including lumbar flat back. Keeping forces lower while still achieving the desired correction is expected to lead to fewer hardware related complications.
“We are looking to finish out the fundraising round (through September) to enable pursuit of a Humanitarian Device Exemption and a pilot IDE [investigational device exemption] trial in children with scoliosis. Since LOADPRO is very similar in construction to ACCUVISTA we feel it will pave the regulatory pathway through FDA as a Class II device.”

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Study: Good early clinical results with SpineArt's cervical disc prosthesis

SPINEART: POSITIVE RESULTS FOR BAGUERA C (Orthopedics This Week)
Spineart is pleased with the recently published results for the BAGUERA C cervical disc prosthesis. The work, which appeared in the Journal of Spine, emanated from a multicenter European prospective registry for the BAGUERA C cervical disc prosthesis. The paper is titled “Radiographic Outcome and Adjacent Segment Evaluation Two Years after Cervical Disc Replacement with the BAGUERA C Prosthesis as Treatment of Degenerative Cervical Disc Disease.”
As indicated in the July 5, 2016 news release, “A retrospective analysis of a large range of radiographic parameters was performed by an independent evaluator: 99 patients, treated for symptomatic degenerative disc diseases, by one- or two-level arthroplasty, using a total of 123 BAGUERA C prostheses were included. Radiographic images at the treated and adjacent levels, as well at the overall cervical region, were analyzed. The results, 2 years after treatment by arthroplasty using BAGUERA C, demonstrate good mobility at the treated and adjacent levels, disc height restoration and clear evidence of adjacent levels preservation. There were no signs of subsidence of the prostheses. Measures at the adjacent levels showed no signs of degeneration or kyphosis. Occurrence of heterotopic ossifications was considered low compared to data published by independent evaluators for other disc prosthesis. The publication further established cervical arthroplasty using the BAGUERA C disc prosthesis as a safe, effective and motion preserving surgical treatment. The author also considered the results encouraging in terms of adjacent level disease protection.”
Asked how mobility was measured, Jerome Tridivic, COO of Spineart, told OTW, “Mobility is primarily defined by the range of motion which was evaluated through measurements on radiographic images preoperatively, at 6 weeks follow-up and at 2 years follow-up for parameters in neutral, flexion and extension position. The measurements were performed by an independent laboratory using a semi-automated process. The process relied on preliminary manual annotations using a graphical user interface for capturing specific coordinates and an automated algorithm for angle calculation. Both the user interface and automated components were specifically developed by the laboratory for the purpose of this study.
“Radiographic evaluations for disc prosthesis are interesting as most available data on disc replacement focus mainly on outcomes such as NDI, VAS, SF-36 scores…. This radiographic evaluation of the BAGUERA C disc prosthesis allowed us to look at the benefits of cervical arthroplasty through a different perspective. A significant amount of thought and effort from the authors went into developing the methodology and automated tools required to assess the range of motion, disc angle and disc height at the operated and adjacent level. It is very satisfying to see their work being published.”
 

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