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Purpose of study

This RCT is to determine whether or not there is a clinical benefit from inserting a dynamic stabilising implant such as the Wallis ligament on the functional recovery of patients who have undergone lumbar decompression surgery. This Interspinous implant was developed as an anatomically conserving procedure without recourse to lumbar spinal fusion surgery. The biomechanical studies have shown that unloading the disc and facet joints reduces intradiscal pressures at same and adjacent levels. The aim of this study was to identify a patential Wallis affect.

Methods

Ethicallly approved. Patients were randomized into 2 groups, decompression alone or decompression with wallis interspinous ligament stabilisation. Patients were assessed pre operatively and post operatively every 6 months by VAS pain score and Oswestry Disability Index.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 52 - 52
1 Apr 2012
Findlay I Mahir S Marsh G
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Male retrograde ejaculation is a well-documented but rare complication of anterior approach lumbar spine surgery. Retraction of the soft tissues which encase the superior hypogastric plexus leads to dysfunction of the sympathetic control of the bladder neck sphincter. We postulated that similar nerve root dysfunction in females may lead to bladder problems and sexual dysfunction.

The Female Sexual Function Index Questionnaire was sent to 20 consecutive women who had undergone anterior spinal surgery by the senior author (GM).

Questionnaires were returned by 11 of the 20 subjects. 6 had undergone disc replacement surgery and 5 anterior lumbar interbody fusion. All procedures used an anterior retroperitoneal approach. The age range was 20 to 49 years (mean 40.2 years). There were no immediate peri-operative complications. The mean time since surgery was 4.9 years (range 3.1 to 5.8 years).

The Female Sexual Function Index is a validated questionnaire used internationally as the gold standard measure of sexual dysfunction in women. Urinary frequency and incontinence were also recorded.

9 women (82%) described a degree of post-operative sexual dysfunction with 7 (64%) recording urinary frequency and urge incontinence.

Although some sexual dysfunction may be expected from pre-existing conditions, we highlight this complication following anterior lumbar spine surgery in females. We plan to further investigate its incidence and possible resolution of symptoms after a prolonged period in a larger case series.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 145 - 145
1 Apr 2012
Mahir S Marsh G Lakkireddi P
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The purpose of this retrospective study, is to demonstrate the survivorship and clinical effectiveness of the Wallis implant, against low back pain and functional disability in patients with degenerative lumbar spine disease.

The Wallis Interspinous implant, was developed as a minimally invasive and anatomically conserving procedure, without recourse to rigid fusion procedures. The initial finite element analysis and cadaver biomechanical studies showed that the Wallis ligament improves stability in the degenerate lumbar motion segment. Unloading the disc and facet joints reduces intradiscal pressures at same and adjacent levels allowing for the potential of the disc to repair itself.

A total of 157 patients who had wallis ligament insertion between 2003 and 2009 were reviewed, with a mean age of 54 and were followed for 48 months on average.

Patients were assessed pre-operatively and post-operatively every 6 months by VAS pain score, Oswestry Disability Index and SF-36.

90% of patients improved, to show a minimal clinical difference, compared to the pre-operative evaluation. There is overall 75-80% good clinical outcome.

Low infection rate of 1.1%. Two cases of prolapsed discs at the same level requiring further discectomy, 7 required fusion. No fractures or expulsions.

The Wallis implant represents a safe non-fusion stabilisation device in the treatment of degenerative lumbar spine disease with canal stenosis. There is less soft tissue damage, quick rehabilitation, less morbidity and associated low complication rate.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 481 - 481
1 Sep 2009
Gangone R Lakkireddi P Kotrba M Marsh G
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Background: A common problem achieving lumbar spinal fusion is developing a pseudarthrosis. The current gold standard in achieving fusion is the use of autograft from pelvis or posterior elements of the spine. However the potential limitations of insufficient quantity and donor site morbidity have led to the use of bone graft alternatives such as DBM which contains osteoinductive BMPs.

Aims & Methods: A prospective randomized control trial comparing the effectiveness of Demineralised Bone Matrix (DBM Putty)/autograft composite with autograft in lumbar postero-lateral or 270 degree spinal fusion.

35 patients were required for the study. They were randomized to have DBM and autograft on one side of the posterior approach and autograft alone on other side of the same approach. Patients were followed up with interval radiographs for total of 24mons. To date 32 patients have been recruited and with an average follow up a15.3 months. The mineralization of fusion mass lateral to the instrumentation on each side was graded as Absent, Mild (< 50%), Moderate (> 50%) or Complete fusion (100%). The assessment was made by independent orthopaedic consultant and a musculoskeletal radiologist who were blinded to graft assignment.

Results: The sex distribution was 17:15 male to females with a mean age of 55.2 (21–87years) and an average follow up of 15.3mons (3–24mons). 50% of patients had single level fusion and the remainder had more than one level fusion. At 12months, on the side of DBM 28% had complete fusion, 65% had moderate fusion, and 7% had no fusion mass. During the same period on the other side (non DBM side) approx 25% did not show any sign of fusion. There was no correlation with number of levels, age or sex.

Conclusions: Osteoinductive properties of DBM would appear to enhance the consolidation of the lumbar spinal fusion. DBM reduces the amount of harvested autograft graft and also minimises the morbidity of donor site complications.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 481 - 481
1 Sep 2009
Gangone R Lakkireddi P Prasad V Kotrba Marsh G
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Aim: To assess the outcome of patients with chronic discogenic lumbar back pain who underwent intradiscal electro thermal therapy (IDET).

Design: A prospective longitudinal study

Subjects: Patients undergoing IDET in our unit between April 2000 and October 2007 were included in the study after assessment with discography and diagnostic imaging. Discographic concordant symptoms with subsequent abolition with local anaesthetic led to inclusion in the study regardless of discogram volume.

Outcome Measures: Subjects were assessed preoperatively with VAS pain scores, SF36, demographic data and pain diagrams. Then were then reassessed postoperatively with the, VAS pain scores SF36, employment status and subjective outcome at 6, and 12 months.

Results: 83 patients were treated with IDET. We had a follow up rate of 75% leaving a cohort of 65 patients. Mean follow up 7.6 months.

Overall there was a mean improvement in pain VAS scores of 1.9 (p=0.0875).

SF36 scores showed minimal improvement in both physical and mental parameters and there was minimal improvement in subjective outcome in 55% of patients.

However it was observed that a small subgroup of patients (30%) aged less than 40 with low volume positive discography and single level disease mean pain VAS scores improved by 3.78 from 7.52 to 3.74. 72% of these patients reported a subjective improvement in symptoms and SF36 scores improved significantly compared to the overall group.

Further analysis also revealed that the use of pain diagrams when interpreted according to the principles of Mann et al was the predictive value.

Conclusions: Patient selection seems to be crucial in determining a successful outcome using IDET. We still perform this procedure on those patients aged less than 40 with single level disease, positive low volume discography, no facet joint arthritis and an organic pre procedure pain diagram.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 527 - 527
1 Aug 2008
Lakkireddi MP Heilpern G Jones HW Marsh G
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Purpose of Study: To determine whether pre operative psychological assessment can be used to predict the outcome following intradiscal electro thermal therapy (IDET).

Materials and Methods: Patients undergoing IDET at our unit were asked to complete a pain diagram and a Short Form 36 (SF36) (UK Version 1). Patients were followed up after IDET by means of a postal questionnaire. Patients outcome was assessed using a visual analogue pain score (VAS), an SF36 and a subjective outcome assessment. Pain drawings were classified as organic and non-organic according to the principle described by Mann et al.

Results: Forty-six (80.7%) patients were successfully followed up. Mean age was 41.2 years (range 16–76), 27 were female and 19 male. 73.9% of the pain diagrams were classified as organic and 26.1% as non-organic. The pain diagram was a good predictive tool for outcome following IDET. Patients with ‘organic’ pain drawings showed an improvement in mean pain VAS (pre 6.7, post 5.9), high patient satisfaction (Better 67.6%, Same 11.8%, Worse 20.6%), and higher physical component scores of the SF36 (Physical 64.1, Physical Role 45.6, Pain 54.0) compared to the ‘non-organic’ group who demonstrated a deterioration in mean pain VAS (pre 6.5, post 8.2), low patient satisfaction (Better 8.3%, Same 58.3%, Worse 33.3%), and lower physical component scores of the SF36 (Physical 38.3, Physical Role 20.8, Pain 26.5).

Conclusions: Several authors have shown that certain preoperative psychological characteristics are associated with a poor outcome from spinal surgery. Our findings suggest that pre procedure psychological assessment is useful in predicting which patients will have a favourable outcome from IDET. Pain drawings are quick and easy for patients to complete.

It might be a useful predictor in most of the spine surgery. We have incorporated pain diagrams in the questionnaires of patients undergoing anterior spinal surgery and dynamic stabilisation of spine.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_II | Pages 217 - 217
1 Jul 2008
Trehan R Chan J Helipern G Packham I Marsh G Knibb A
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Objective: This is a prospective, randomised, double blind trial to assess the effectiveness of intrathecal fentanyl in the relief of post-operative pain in patients undergoing lumbar spine surgery.

Method: 60 patients were recruited. All received our standard analgesic regime with morphine PCA via a syringe driver. They were electronically randomised to two groups – one received 15 micrograms of fentanyl intathecally; the other had nothing. The fentanyl was administered by the operating surgeon under direct vision at the end of the procedure.

All patients were monitored in recovery for two hours. Visual Analogue Scale (VAS) pain scores were assessed at 2, 4, 24 and 48 hours post-op. The time to first bolus delivery of PCA was recorded as was the total amount of morphine PCA used. Both patient and assessor were blinded.

Results: The patients randomised to receive fentanyl showed a significant decrease in their mean VAS pain scores for the first 24 hours. Their time to first bolus of PCA was significantly increased. They also used 40% less morphine PCA (p< 0.05 in all cases). None of the patients suffered respiratory compromise requiring treatment and they all left recovery after 2 hours to be nursed on the general ward.

Conclusion: Intrathecal fentanyl is effective at reducing post-operative pain and PCA morphine use after lumbar spinal surgery. We support its use over morphine because of the reduced incidence of respiratory complications and the ability to nurse patients on a general ward.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_II | Pages 320 - 320
1 Jul 2008
Gill IR Hamilton PD Pearce SJ Marsh G
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This is a prospective study of 74 consecutive LCS total knee replacements of which 34 were meniscal-bearing and 40 rotating-platform total knee arthroplasties comparing functional and radiological outcome measures of the New Jersey total knee replacement.

The study is based on a cohort of 96 patients who were followed up over a period of 8.6 to 15.6 years (mean 11.8 years). 49 patients (64 knees) were living and 5 patients were lost to follow-up. At time of follow-up 37 patients were dead. The patients were aged 23 to 81 (mean 64.5) at the time of surgery.

The methods used include a pre- and post-operative New Jersey Orthopaedic Hospital Scoring Scale (NJOHSS). In addition the cohort were assessed postoperatively using the Knee Society Score (KSS) and the Knee Society Radiological Evaluation Form (KSREF).

The results of the study showed that there was a significant overall improvement in the NJOHSS (mean improvement = 22.4 points) with 81% of the cohort scoring ‘good to excellent’ post-operatively. When the two types of arthroplasty were compared there was no significant difference in improvement in the NJOHSS. However, both the ‘Post-op’ and ‘Function’ components of the post-operative KSS were greater in the rotating-platform total knee replacement. The comparison of the post-operative KSREF did not show any significant differences between the two types of arthroplasty.

Revision procedures were carried out in 3 patients with meniscal-bearing arthroplasty and 2 patients with rotating-platform arthroplasty. Of the Meniscal-bearing group two were for sepsis and one required liner exchange. Both of rotating-platform group were revised for aseptic loosening.

We therefore conclude that there was excellent long-term survival of the LCS knee arthroplasty in this cohort and there was no significant difference in functional outcomes for either knee replacement. We also note that there have been no revisions for aseptic loosening in the meniscal-bearing group to date.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_II | Pages 221 - 221
1 May 2006
Chan JHH Heilpern G Packham I Marsh G Knibb A
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Objective To assess the effectiveness of intrathecal fentanyl in the relief of post operative pain in patients undergoing lumbar decompression or fusion.

Method 60 patients undergoing lumbar spinal surgery were prospectively recruited. All patients received our standard analgesic regime with PCA via a syringe driver. They were also randomised to receive either 15 micrograms of fentanyl intrathecally, or nothing. The fentanyl was administered by the operating surgeon (GM) under direct vision one or two levels above the site of the operation at the end of the procedure. VAS pain scores were taken at 2, 4, 24 and 48 hours post operatively independently. The total dose of morphine required was recorded.

Results The patients randomised to receive fentanyl showed a decrease in their mean VAS scores as well as a 40% reduction in the total morphine dose delivered. There was no increased incidence of side effects in the group receiving fentanyl. No patients suffered respiratory compromise requiring treatment. All patients left recovery after 2 hours to be nursed on an open ward.

Conclusion Intrathecal fentanyl is effective at reducing mean pain VAS scores and morphine use via a PCA after lumbar spinal surgery. We would support its use over intrathecal morphine because of the reduced incidence of respiratory complications and the ability to nurse patients on the open ward.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_II | Pages 300 - 300
1 May 2006
Trehan R Chan J Marsh G
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Giant cell tumour of tendon sheath is usually benign in nature but their tendency to recur is well known, this cause problems for surgeons and there is always a puzzle in determining the appropriate therapy. This study was done to highlight characteristics, differential diagnosis and current options of treatment for giant cell tumour of tendon sheath.

We report two cases treated at our hospital. Both are females, one of 24 years while other was 65 years at the time of diagnosis. First patient had incidental associated benign teratoma of ovary as well. One tumour was of thumb in non dominant hand while in older patient it was at distal interphalangeal joint of ring finger in dominant hand. Both presented with history of slowly growing painful swelling, they were treated with local excision but in both patients there was an aggressive local recurrence. Revision surgery was performed with wider local excision. There was no recurrence this time.

Giant cell tumour of tendon sheath is mostly benign condition but need to be differentiated from serious conditions like clear cell sarcoma. Therapy of choice is local excision. Wider excision after surgery should be reconsidered where microscopic examination reveals a lesion with characteristics suggestive of potential aggressive behaviour. A literature review and discussion of salient diagnostic and treatment issues is included.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_II | Pages 218 - 218
1 May 2006
Chan JHH Heilpern G Marsh G
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Objective A prospective longitudinal study with a mean 22 month follow up (range 6–36 months) to assess the outcome of patients with chronic discogenic lumbar back pain who underwent intradiscal electrothermal therapy (IDET).

Method Patients with a discogenic origin of their back pain confirmed by diagnostic imaging and discography and who underwent IDET were included in the study. Discographic reproduction of symptoms with subsequent abolition with local anaesthetic led to inclusion in the study regardless of discogram volume. Outcome was assessed using VAS pain scores, Oswestry Disability Index (ODI) scores, employment status, subjective outcome and pain diagrams.

Results 68 patients were treated with IDET. 51 patients were successfully followed up for a minimum of one year, of whom 31 had at least 2 year follow up. These patients were divided into two groups. Group 1 consisted of 29 patients aged less than 40 with single level disease, no facet joint arthritis, a low volume positive discogram and an organic pain diagram. Their mean VAS scores decreased from 7.52 to 3.84 (p< 0.001). 70% reported a good or excellent outcome with only 30% fair or poor. Group 2 included the remaining 22 patients. Their mean VAS decreased from 7.41 to 6.13 and only 32% reported a good or excellent outcome with 68% fair or poor.

Conclusion We conclude that with very strict selection criteria, IDET can have a successful outcome.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_II | Pages 300 - 300
1 May 2006
Trehan R Packham I Mehrotra P Marsh G
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Malignant change in existing benign enchondroma of phalanx of hand to chondrosarcoma of hand is extremely rare. Books suggest that chondrosarcoma does not arise in small bones of hands and feet although in literature few cases have been reported but not described comprehensively.

We report a rare case of chondrosarcoma in distal phalanx of ring finger in a 75- year old healthy female who had cystic lesion for past 25 years with recurrent fractures. Patient came to us with severe pain and tender, hard swelling of distal phalanx of left ring finger. X ray showed pronounced expansion of the terminal phalanx surrounded partially by a shell of bone, with focal spotty calcification with in the lesion. Because of sudden increase in size and pain of swelling, an amputation was performed at distal inter phalangeal joint. Histopathology showed grade II myxoid chondrosarcoma with pre-existing enchondroma. Wound healed nicely. Extensive investigation in form of CT chest and bone scan did not show any metastasis. Five year follow up did not show any local recurrence or distant metastasis.

Clinical suspicion should be aroused in an older individual with a previously relatively quiescent lesion that becomes larger and painful. Usually course of the tumour is slow and metastasis to lungs is late. Treatment of choice is disarticulation a joint proximal to lesion. Prognosis is good if metastasis has not occurred. Once diagnosis is made, patient should be investigated to look for any possible metastasis and must be regularly followed up. A literature review and discussion of salient diagnostic and treatment issues is included.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 153 - 153
1 Mar 2006
Heilpern G Joshy S Marsh G Knibb A
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Objective: To assess the effectiveness of intrathecal fentanyl in the relief of post operative pain in patients undergoing lumbar decompression or fusion. Morphine has been shown to be effective intrathecally in spinal surgery but there is an increased incidence of respiratory complications. Fentanyl has not been formally evaluated in this setting.

Design: This was a prospective randomized double blind trial. All patients received our standard analgesic regime with PCA via a syringe driver. They were also randomized to receive either 15 micrograms of fentanyl intrathecally, or nothing. The fentanyl was administered by the operating surgeon (GM) under direct vision one or two levels above the site of operation at the end of the procedure.

Subjects: 30 patients undergoing lumbar spinal surgery were prospectively recruited.

Outcome measures: VAS pain scores were taken at 2, 4, 24 and 48 hours post operatively. Time to first bolus delivery of morphine from the PCA was also recorded as was the total dose of morphine required.

Results: The patients randomized to receive fentanyl showed a significant increase in the time to first bolus delivery of morphine as well as a 40% reduction in the total morphine dose delivered. There was also a decrease in their mean VAS scores. There was no increased incidence of side effects in the group receiving fentanyl. No patients suffered respiratory compromise requiring treatment and only 2 patients required HDU observation overnight. The rest of the cohort left recovery after 2 hours to be nursed on an open ward.

Conclusion: Intrathecal fentanyl is effective at reducing morphine use via a PCA and mean pain VAS scores after lumbar spinal surgery. We would support its use over intrathecal morphine because of the reduced incidence of respiratory complications and the ability to nurse patients on the open ward.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 293 - 294
1 Sep 2005
Heilpern G Marsh G Knibb A
Full Access

Introduction and Aims: To assess the effectiveness of intrathecal fentanyl in the relief of post-operative pain in patients undergoing spinal surgery.

Method: Sixty patients undergoing lumbar spinal surgery were prospectively recruited. All patients received our standard analgesic regime with PCA via a syringe driver. They were also randomised to receive either 15 micrograms of fentanyl intrathecally, or nothing. The fentanyl was administered by the operating surgeon (GM) under direct vision one or two levels above the site of operation at the end of the procedure. VAS pain scores were then taken at two, four, 24 and 48 hours post-operatively. Time to first bolus delivery of morphine from the PCA was also recorded, as was the total dose of morphine required.

Results: The patients randomised to receive fentanyl showed a significant increase in the time to first bolus delivery of morphine, as well as a 40% reduction in the total morphine dose delivered. There was also a decrease in their mean VAS scores. There was no increased incidence of side effects in the group receiving fentanyl. No patients suffered respiratory compromise requiring treatment and only two patients required HDU observation overnight. The rest of the cohort left recovery after two hours to be nursed in an open ward.

Conclusion: Intrathecal Fentanyl is effective at reducing morphine use via a PCA and mean pain VAS scores after lumbar spinal surgery. We would support its use over intrathecal morphine because of the reduced incidence of respiratory complications and the ability to nurse patients in the open ward


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 238 - 238
1 Sep 2005
Heilpern G Marsh G Knibb A
Full Access

Study Design: Prospective randomized double blind trial.

Objective: To assess the effectiveness of intrathecal fentanyl in the relief of post operative pain in patients undergoing lumbar decompression or fusion.

Summary of Background Data: Morphine has been shown to be effective intrathecally in spinal surgery but there is an increased incidence of respiratory complications. Fentanyl has not been formally evaluated in this setting.

Methods: All patients received our standard analgesic regime with PCA via a syringe driver. They were also randomised to receive either 15 micrograms of fentanyl intrathecally, or nothing. The fentanyl was administered by the operating surgeon under direct vision one or two levels above the site of operation at the end of the procedure.

Subjects: 30 patients undergoing lumbar spinal surgery were prospectively recruited.

Outcome measures: VAS pain scores were taken at 2, 4, 24 and 48 hours post operatively. Time to first bolus delivery of morphine from the PCA was also recorded as was the total dose of morphine required.

Results: The patients randomized to receive fentanyl showed a significant increase in the time to first bolus delivery of morphine as well as a 40% reduction in the total morphine dose delivered. There was also a decrease in their mean VAS scores. There was no increased incidence of side effects in the group receiving fentanyl. No patients suffered respiratory compromise requiring treatment and only two patients required HDU observation overnight. The remainder of the cohort left recovery after 2 hours to be nursed on an open ward.

Conclusion: Intrathecal fentanyl is effective at reducing morphine use via a PCA and mean pain VAS scores after lumbar spinal surgery. We would support its use over intrathecal morphine because of the reduced incidence of respiratory complications and the ability to nurse patients on the open ward.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_I | Pages 35 - 35
1 Mar 2005
Heilpern G Jones HW Marsh G
Full Access

Purpose of Study: To determine whether preprocedure psychological assessment can be used to predict the outcome following intradiscal electrothermal therapy (IDET).

Materials and Methods: Patients undergoing IDET at our unit between April 2000 and March 2002 were asked to complete a pain diagram and a Short Form 36 (SF36) (UK Version 1). Patients were followed up after IDET by means of a postal questionnaire. Patients outcome was assessed using a visual analogue pain score (VAS), an SF36 and a subjective outcome assessment. Pain drawings were classified as organic and non-organic according to the principle described by Mann et al.

Results: Forty-six (80.7%) patients were successfully followed up. Mean age was 41.2 years (range 16–76), 27 were female and 19 male. 73.9% of the pain diagrams were classified as organic and 26.1% as non-organic. The pain diagram was a good predictive tool for outcome following IDET. Patients with ‘organic’ pain drawings showed an improvement in mean pain VAS (pre 6.7, post 5.9), high patient satisfaction (Better 67.6%, Same 11.8%, Worse 20.6%), and higher physical component scores of the SF36 (Physical 64.1, Physical Role 45.6, Pain 54.0) compared to the ‘non-organic’ group who demonstrated a deterioration in mean pain VAS (pre 6.5, post 8.2), low patient satisfaction (Better 8.3%, Same 58.3%, Worse 33.3%), and lower physical component scores of the SF36 (Phsical 38.3, Physical Role 20.8, Pain 26.5).

Conclusions: Several authors have shown that certain preoperative psychological characteristics are associated with a poor outcome from spinal surgery. Some authors have demonstrated a correlation between these characteristics and pain diagrams when they are judged as ‘organic’ and ‘non-organic’. Our findings suggest that preprocedure psychological assessment is useful in predicting which patients will have a favourable outcome from IDET.

Pain drawings are quick and easy for patients to complete. Our study demonstrates pain drawings can reliably be used to predict outcome following intradiscal electrothermal therapy.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_I | Pages 39 - 39
1 Mar 2005
Heilpern G Jones HW Marsh G
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Purpose of Study: It has been widely reported that smokers undergoing lumbar spinal surgery are more likely to develop postoperative complications such as pseudarthrosis, superficial and deep wound infection, as well as diminished clinical improvement. New spine instrumentation was developed (SpineLinkTM, Biomet) which enables surgeons to fuse multiple levels by linking single level fusions in series. This is accomplished through titanium links and polyaxialscrews which preserve lordosis without the bending of rods or plates. During an ongoing 5 year prospective investigation on fusion with intrasegmental fixation the authors analysed and compared outcomes in smokers versus non-smokers to determine the impact of this new system on outcomes in smokers.

Materials and Methods: 64 patients who underwent spine fusion with intrasegmental fixation were prospectively studied at Mayday University Hospital beginning in 1997, 54 have sufficient follow-up to be included in the analysis. Patients were assessed pre and postoperatively, both radiographically and clinically, using validated outcome instruments including the SF-36.

Results: There were 54 patients in the analysis (34 patients in the smoker group and 20 patients in the non-smoking group) with an average age of 52 years and an average follow-up of 28 months. 32 patients had multilevel procedures (25 two level, 5 three level, 2 four level). The treatment groups were comparable with respect to demographic, diagnostic (53% spondylolisthesis, 35% degenerative disc disease, 12% other) and surgical variables. No other significant medical problems affected patients in either group. Radiographically there were no pseudarthroses observed in either group. The SF-36 physical health score increased from 22.4 to 40.1 (+18.0) following surgery in smokers compared to an increase from 25.0 to 36.0 (+11.0) in non-smokers. The SF-36 mental health score increased from 36.4 to 45.0 (+8.6) in smokers compared to an increase of 30.8 to 42.7 (+2.9) in non-smokers. Complications included 2 nerve root injuries requiring hardware removal, and 3 deep infections which resolved with appropriate treatment.

Conclusions: There were no differences between smokers and non-smokers in radiographic fusion success or postoperative complications. As expected, smokers had lower SF-36 physical health and mental health scores pre-op, but unexpectedly, smokers had a greater degree of improvement in these scores postoperatively than non-smokers. Thus, from our experience, there is an incremental benefit to the use of intrasegmental fixation in smokers and warrants further investigation.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_I | Pages 38 - 38
1 Mar 2005
Heilpern G Marsh G Jones HW
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Purpose of Study: To prospectively study the outcome of lumbar interbody fusion with an intrasegmental device, and to determine whether smoking, previous surgery and multiple level surgery have an effect on fusion rate.

Methods Used: Between October 1998 and July 2001, 67 patients underwent lumbar interbody fusions using an intrasegmental pedicle screw system (Biomet, Spinelink). Prior to surgery Short Form 36 (UK Version 1) (SF36) scores, pain visual analogue scores (VAS) and patient demographics were recorded. Postoperative follow up was in a specialist spine clinic. Patients were followed up in this clinic until fusion was judged to have occurred both clinically and radiographically. Fusion was judged to have occurred radiographically when there was evidence of a fusion mass at all fused levels and absence of pedicle screw loosening and/or metal work breakage. Patients who were not judged to have fused were classified as either a pseudarthrosis, or indeterminate. Patients completed a questionnaire on attendance at clinic, or by post if discharged. This included an SF36, Oswestry Disability Index, employment status, analgesic use and patient satisfaction assessment.

Results: 67 patients (38 male and 29 female) were successfully followed up. The mean age was 45.2 (range 17–86). Mean follow up was 21.7 months (range 12–43 months). 36 posterolateral fusions and 31 combined posterior lumbar interbody/posterolateral fusions were performed. 22 patients were smokers and 45 non-smokers or ex-smokers at the time of surgery. 18 patients had undergone previous surgery (either discectomy, decompression or fusion). 34 patients had 2 vertebral levels fused, and 33 patients more than 2 vertebral levels.

There was radiographic evidence of fusion in 81.3% of patients. There was an improvement in mean pain VAS, and mean scores of all physical components of the SF36. Patient satisfaction was high (71%).

Subgroup analysis demonstrates that the fusion rates in non-smokers versus smokers, and primary fusions versus previous surgery, were the same. The fusion rate following multiple level fusions was lower at 72.2%.

Conclusions: The results of our study suggest that high fusion rates can still be achieved in high risk patients when an intrasegmental device is used.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 354 - 354
1 Mar 2004
Jones HW Marsh G
Full Access

Aims: The aim of our study was assess the outcome following intradiscal electrothermal therapy in patients with chronic discogenic back pain. Methods: 57 patients underwent IDET. All patients had an MRI and provocative discography to conþrm that their pain was of disco-genic origin. Pre-IDET, patients completed: a pain visual analogue score (VAS), an employment assessment and a pain diagram. Post-IDET assessment included a VAS, a subjective outcome assessment, an SF36 and an employment assessment. Results: 46 (80.7%) patients with a mean age of 41.2 years (range 16–76) were successfully followed up. IDET performed at one level in 48 patients and at two levels in 9. The mean follow-up was 19 months (Range 12–32 months). There were 27 males and 19 females. There were no serious complications. The mean pain VAS was 6.6 pre-IDET and 6.3 Post IDET (not signiþcant). 54% of patients stated that they were either Ç much better È or Ç a little better È. Subgroup analysis suggests that neither the presence of mild facet joint arthritis nor undergoing IDET at more than one level has an effect on outcome. Ç Non-organic È preoper-ative pain diagrams (as assessed by principles described by Mann et al) had a signiþcant negative effect on outcome, with patients in this group having a having a deterioration in VAS from 6.75 to 8.3 and only 10% stating that their pain was Ç a little better È and none Ç much better È. Conclusion: We believe that our study demonstrates that IDET can achieve satisfactory results in the treatment of chronic discogenic low back pain, but that patient selection is important in achieving this outcome.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_II | Pages 114 - 114
1 Feb 2004
Jones HW Marsh G
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Objectives: The aim of this study was to determine the outcome of posterior lumbar fusion performed using an intrasegmental pedicle screw device.

Design: Prospective Case Series.

Subjects: 83 consecutive patients underwent posterior lumbar fusion for the intrasegmental pedicle screw device between October 1998 and November 2001. The mean age was 46.8 (range 1786) and 46 were male and 37 female. 40 patients had a single intervertebral level fusion, 34 two level and 7 three level. 23 patients had undergone previous spinal surgery and 29 were smokers.

Outcome Measures: Fusion status was assessed using radiographs (lateral, AP and in the plain if the intervertebral disc). To be judged as fused, there had to be an absence of metalwork failure, no pedicle screw loosening and fusion at all levels if a multi-level fusion.

Patient outcome was assessed by means of a visual analogue scale (VAS) for pain, SF36 health assessment questionnaire, a patient subjective outcome assessment, employment status and analgesic usage.

Results: Patients were followed up for a minimum of one year. Fusion was successfully achieved in 80 (96%) patients.

The mean VAS reduced by 2.2 points from 8.2 to 5.9 (p=0.007). There was a significant improvement in all the physical component scores of the SF36. The subjective outcome was either excellent or good in 65% of patients. Analgesia usage reduced in 71% of patients. 4 patients underwent further surgery. One patient died in the post operative period. There was no significant difference in the fusion rate in smokers compared to non smokers, or those that had undergone previous spinal surgery. The subjective outcome was either excellent or good in 59% of smokers, but only 37% in those that had undergone previous surgery.

Conclusions: We believe that our results demonstrate that the use of an intrasegmental pedicle screw device can facilitate high fusion rates with good clinical outcomes in most patients. The fusion rate does not appear to be effected by smoking, or previous spinal surgery.