A neurosurgeon’s experience with PEEK-OPTIMA™ HA Enhanced devices

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Jill Wright Donaldson, MD, is a neurosurgeon at Community Hospital North (Indianapolis, IN, USA), specialising in the surgical management of complex spine disorders, neoplasms of the brain and spine, and peripheral nerve entrapment. Dr Donaldson is a member of many professional organisations, including the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS). Here, she discusses her experiences using both PEEK and additive Titanium implants in the operating theatre, using case examples from her clinical practice, and describes why ultimately, she chose to implant the EVOS-HA device (Cutting Edge Spine) made from PEEK-OPTIMA HA Enhanced (Invibio Biomaterial Solutions™) during spine surgery.

PEEK-OPTIMA HA Enhanced interbody fusion devices preferred to 3D printed Titanium implants

Dr Donaldson initially used 3D printed devices in her practice. Explaining this choice, Dr Donaldson expands on her clinical experiences with these implants: “I was looking for something that would encourage bone on-lay. Traditional PEEK is more hydrophobic and acts much more like a spacer, whereas I was looking for something that would take a more active part in the fusion. I have used several 3D printed devices, including the 4Web Medical and Stryker offerings. Those are two that I still use periodically, so I have not abandoned them altogether. However, I do worry about the endplates in older patients, and the lack of elasticity in a titanium device—it might be a more suitable option for a younger patient.”

In fact, Dr Donaldson says “I prefer to use HA enhanced PEEK for all patients”, citing bone quality in geriatric patients as a cause for concern and a primary driver in the decision making process. Another factor Dr Donaldson takes into consideration is imaging. She expands, “My experiences with 3D printed devices were overall positive. I did not have any significant re-operative cases or any significant problems. There were a few incidences where I thought the device subsided into the endplates, but clinically the patients still did well. The decision to move away from 3D printed devices was not really a clinical one as much as a radiographic one: I did not like the X-ray as much with the titanium implants.”

“This is because the titanium implants are not radiolucent, unlike PEEK. I typically follow all of my patients for a year; as long as they are doing well at the end of that year and
there have been no significant changes in their implants, I assume they are fused. I will
only do a CT if they are having symptoms. One of the big perks of PEEK, whether it is
HA enhanced or the traditional material, is that it is radiolucent, allowing you to monitor
the implant over time and follow the fusion better than with an X-ray.”

The move towards HA Enhanced PEEK implants has been a “game changer”

Hydroxyapatite enhanced PEEK has been revolutionary. Speaking of her personal
clinical experiences, Dr Donaldson explains, “Once the HA device changed the properties
of PEEK so that the material is more of an active player in fusion, that was a real game
changer for me.” In addition to the superior imaging properties of PEEK, Dr Donaldson
finds that her patients appear to be recovering from the fusion quicker when the
interbody fusion device used was a PEEK-OPTIMA HA Enhanced cage compared to 3D printed Titanium alternatives.

She reports, “My observation is that the patients seem to be getting better faster, and
I think some of that is just due to the fact that PEEK has a different elasticity to it, and it is not as rigid. At earlier office visits, clinically, my patients look healthier; at six weeks
post-operatively they look like a three-month post-operative 3D printed Titanium patient,
and they really seem to be doing much better much more rapidly, they seem to be ahead
of the game. I give them all strict activity restrictions for three months, but patients at
six weeks walk in and for most of them you cannot tell they have had surgery. They truly seem to be healing faster.”

Even right after surgery, Dr Donaldson reports a speedier recovery in patients
fused with the EVOS-HA devices. In the cases presented here, the patients were
all discharged from the hospital two days post-operatively, which is typical of this
type of procedure. However, Dr Donaldson adds: “I have had several patients recently
that probably could have gone home the next day, and a couple that have actually left
the day after surgery. They truly look great and there is no reason to keep them. It is a
clinical decision, not an insurance one; the HA enhanced PEEK really makes an impact.”

Furthermore, Dr Donaldson also reports her patients fused with an EVOS-HA device are
becoming opioid independent sooner than her other fusion patients. “Some of them take
narcotics for a week and they are done, and they really seem to have a lesser need for pain medication for the most part much sooner,” she told Spinal News International. In the midst of the opioid epidemic, Dr Donaldson stresses the importance of reducing postoperative narcotic consumption: “It is critical. The faster you can get people off pain
medication, the more active they are, and the better they do. There is so much concern with addiction and narcotics, now more than ever, that any time you can get somebody off pain medication in a quick fashion, it makes an enormous difference.”

Successful interbody fusion in a geriatric patient using a PEEK-OPTIMA HA Enhanced cage

Pre-operative MRI scan

Case description

A 78-year-old female patient presented with progressively severe back and bilateral leg pain, radiating into both hamstrings. She had failed extensive conservative treatment, including physical therapy, chiropractic care, and lumbar epidural steroid injections. The patient did not smoke. A physical exam revealed no motor or sensory deficits. She flexed forward significantly when walking.

Surgical intervention

We treated the patient via decompression at the affected levels, L3–L4, and reduction with a mini-open posterior lumbar interbody fusion. The interbody fusion involved the
placement of a bilateral EVOS HA cage (Cutting Edge Spine) in combination with iliac crest autograft from a transfascial approach, local autograft, and bilateral pedicle screws.

Outcome

The surgery was successful. The patient was discharged from hospital and went home two days after surgery, and one week post-operation was off all narcotic pain medication. She experienced no significant back or leg pain at either two weeks or 12-months’ follow-up.

Single-level lumbar fusion in a middle-age female using 3D printed Titanium cages and autograft bone

Case description

A 52-year-old female patient, a non-smoker, presented with progressively severe lower back pain and bilateral leg pain from the buttocks to the hamstrings. Like the patient
detailed in the first case report (see page 8), this individual had failed conservative treatment, including physical therapy and lumbar epidural steroid injections. A physical
exam revealed mild 4+/5 left dorsiflexion and 4+/5 bilateral extensor hallicus longus weakness, as well as hypesthesia in the left foot dorsum.

Surgical intervention

We performed a mini-open posterior lumbar interbody fusion at L5–S1 with Gill-type laminectomy, using 3D printed Titanium bilateral Truss cages (4WEB Medical), iliac
crest autograft from transfascial approach, local autograft, and bilateral pedicle screws.

Outcome

The patient was discharged home on the third day following surgery, so a day later than the patient described in the first case report fused with the PEEK-OPTIMA HA Enhanced device. There was no leg pain and only mild back pain at six weeks and 12 months. Narcotic use was also more extended in this patient; she was off narcotic pain medications after six weeks, compared to just one week in the patients fused using a PEEK-OPTIMA HA Enhanced device.

Single-level lumbar fusion in an elderly male using the EVOS-HA device with autograft bone

Case description

A 70-year-old male, who is a non-smoker, presented with severe lower back pain and bilateral lower extremity pain for two years, with pain from his hips to anterior thigh. He was experiencing chronic left foot numbness and mild weakness from prior left L4–5 discectomy. A physical exam revealed 4+/5 left dorsiflexion weakness, and left foot dorsum hypesthesia with antalgic gait.

Surgical intervention

We performed a mini-open posterior lumbar interbody fusion at L3–4, using bilateral EVOS HA cages (Cutting Edge Spine), iliac crest autograft from transfascial approach, local autograft, and bilateral pedicle screws. This was the same procedure and the same instrumentation as detailed in the first case report.

Outcome

The patient was discharged home on the second day after surgery, and was off narcotic pain medications at seven days’ post-operation. He experienced no leg pain or back pain at six weeks or at six months, but had no change in chronic left foot numbness and weakness.

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