Enrollment of patients to clinical trials in haematological cancer in New South Wales: current status, perceived barriers and opportunities for improvement.

BACKGROUND: Enrolment of cancer patients in clinical trials is associated with significant positive outcomes. There are, however, limited Australian data on enrolment of patients with haematological malignancies to clinical trials. AIM: The aim of this study is to document the number of patients with haematological malignancies enrolled on clinical trials in NSW, to establish the barriers to trial recruitment and to examine possible means by which clinical trials participation may be improved. METHODS: Quantitative data on clinical trial accrual were obtained from all sites participating in clinical trials in haematological malignancies in NSW from 2004 to 2007 and were compared with the cancer incidence data for that period. Qualitative data on barriers and strategies for improvement were gathered using semi-structured interviews with clinical trials professionals from throughout NSW. RESULTS: Between 2004 and 2007 there were significant increases in the number of active centres, clinical trials and trial participation, and by 2007, 10.5% of all eligible patients with haematological malignancies in NSW were enrolled in relevant clinical trials. Resource constraints were the greatest perceived barrier to participation, but the success of clinical trials is also challenged by difficulties associated with communication, ethics review, trial coordination, trial design and support for emerging centres. CONCLUSION: While participation in clinical trials in haematological cancer in NSW improved between 2004 and 2007, participation in clinical trials remains suboptimal. The development of specific strategies to address barriers to participation may facilitate increased enrolment and ultimately improve clinical outcomes in patients with haematological malignancies.

Tenodesis for chronic lateral ankle instability.

The goal of lateral ankle stabilization is restoration and stability without any functional deficit. Obviously, only anatomic reconstruction can prevent deficits in range of motion. As a result, motion loss is unavoidable with tenodesis procedures. Unfortunately, no procedures are available for anatomic reconstruction of subtalar joint instability. Therefore, when there is objective evidence of subtalar joint instability, tenodesis procedures must be considered. The authors believe that stability is more important than range of motion when degenerative changes are present within the ankle joint. Tenodesis results are good for the short term (less than 5 years) but may deteriorate over time (after more than 9 years). Some residual pain is common following tenodesis procedures.

Mosaicplasty for the treatment of osteochondral defects of the ankle joint.

Autogenous osteochondral transplantation is a relatively new procedure for the treatment of osteochondral lesions of the ankle joint. The procedure is reserved for larger stage III and stage IV lesions. The corresponding author has had good preliminary results with a high level of patient satisfaction. The procedure is relatively straightforward and reliable. The need for a second surgical site has not proved to be a great disadvantage of the procedure; no complications have occurred to date at the knee donor site. This procedure, which was first described for use in the knee joint, shows excellent promise for use in the ankle and warrants larger investigational studies to assess outcomes.

Basal cell carcinoma of the nail unit: a case report.

Basal cell carcinomas (BCC) of the foot are rare. A review of the English literature found only 23 cases of BCC reported in the foot, none of which involved the nail unit. The nail unit, which is composed of the nail bed and nail-folds, is an exceedingly atypical site for basal cell carcinomas. A case of BCC of the proximal nail fold of the hallux which was treated with Mohs Micrographic Surgery (MMS) is presented.

Low-molecular-weight heparin for deep vein thrombosis prophylaxis in foot and ankle surgery: a review.

The necessity of prophylaxis for deep vein thrombosis (DVT) in those patients who undergo foot and ankle surgery remains poorly defined. The authors explore and review the low-molecular-weight heparin (LMWH) preparations for use by foot and ankle surgeons. Recent literature has described a low incidence of DVT and pulmonary embolus (PE) following foot and ankle surgery. Nonetheless, it is paramount that foot and ankle surgeons be aware of the potential risk factors and methods of prophylaxis for DVT. Many options are available for prophylaxis. This article presents a review of DVT with particular attention given to distinguishing risk factors, prophylaxis, and LMWH preparations.

Predislocation syndrome: a review and retrospective analysis of eight patients.

Predislocation syndrome is defined as an either an acute, subacute, or chronic inflammatory process involving the lesser metatarsophalangealjoints. If left untreated, this process can lead to plantarplate and capsular attenuation and metatarsophalangeal joint instability. A retrospective analysis were performed on eight patients who were treated with a flexor tendon transfer for this condition. A subjective analysis and chart review were performed to determine the final outcome of these patients. All patients had a chief complaint of a painful second metatarsophalangeal joint with seven of eight patients having an associated hallux valgus deformity. Excellent results were achieved in six patients. Residual stiffness was the primary complaint of two patients following surgery, suggesting that metatarsophalangeal joint stiffness may be a potential problem after flexor digitorum longus tendon transfers. However, we concluded that the flexor digitorum longus tendon transfer remains an excellent procedure for second toe instability and late-stage predislocation syndrome. A literature review describing the epidemiology, symptom complex, physical findings, radiographic signs and therapies used to manage predislocation syndrome were also discussed.

Ostectomy for diabetic neuroarthropathy involving the midfoot.

Diabetic neuroarthropathy is a frequent complication of diabetes mellitus that results in instability of the foot, structural deformity, and soft-tissue breakdown secondary to increased plantar pressure. The midfoot is commonly involved in diabetic neuroarthropathy. Collapse of the medial, lateral, or both longitudinal arches may result in increased plantar pressures and subsequent midfoot ulceration. The majority of these wounds can be managed with local wound care, off-loading, and other forms of nonoperative care. Surgical intervention becomes necessary when the wound fails to heal with conservative measures. The authors performed a retrospective review of patients who underwent ostectomy for chronic or recurrent ulceration in the midfoot secondary to diabetic neuroarthropathy. The authors reviewed 27 procedures in 20 patients. There were 18 medial ulcers and 9 lateral ulcers. Wounds had resolved in 20 of 27 cases for 74% healing rate. The majority of failed procedures involved lateral column wounds (six of seven). Revisional surgery was required in five of the nine lateral column wounds for limb salvage. There was a statistically significant difference between the rate of complications by ulcer location (p = .00174). The rate of complications was significantly higher for lateral column ulcers. These results indicate that ostectomy is a reasonable option for medial column ulcers that fail nonoperative care. However, ostectomy for ulcers involving the lateral column is less predictable and failure often requires complex reconstructive soft tissue and osseous procedures for limb salvage.

Posterior calcaneal displacement osteotomy for adult acquired flatfoot.

The authors retrospectively reviewed 24 patients who underwent posterior calcaneal displacement osteotomy (PCDO) for posterior tibial tendon dysfunction and adult acquired flatfoot deformity from 1991 to 1996. The average follow-up was 27 months. Analysis consisted of preoperative and postoperative evaluation of radiographs, as well as postoperative subjective results. Ancillary procedures included flexor digitorum longus tendon transfer (n = 19), tendo Achilles lengthening (n = 21), tibialis anterior tendon transfer (n = 5), naviculocuneiform joint arthrodesis (n = 4), and first metatarsocunieform joint arthrodesis (n = 1). The talo-first metatarsal angle on the lateral view decreased from a preoperative average of 22.13 degrees to a postoperative average of 8.50 degrees. The talo-first metatarsal angle on the anteroposterior view decreased from an average preoperative value of 22.96 degrees to a postoperative average of 11.04 degrees. In all cases, talar head coverage at the talonavicular joint improved. Subjective results were categorized as good (n = 17), satisfactory (n = 5), and poor (n = 2). Complications included sural neuritis (n = 6), Achilles tendon rupture (n = 2), difficulty with fixation (n = 2), and undercorrection of deformity (n = 2). Patients who had higher preoperative and postoperative talo-first metatarsal angles on either the anteroposterior or lateral radiographs had significantly poorer outcomes (p = .0403, p = .002, p = .009, p = .001, respectively). In addition, those patients who had medial column fusions had statistically significant poorer subjective results (p = .015). Patients who had flexor digitorum longus (FDL) tendon transfers did significantly better than those patients who did not have FDL transfer (p = .004). The authors conclude that the posterior calcaneal displacement osteotomy is a reasonable option for management of posterior tibial tendon dysfunction in the adult acquired flatfoot.

Soft-tissue reconstruction for recalcitrant diabetic foot wounds.

Thirty-three consecutive patients with plantar soft-tissue defects were managed by a single surgeon (EDN) with reconstruction by a medial plantar artery (MPA)-based flap. Foot defects resulted from a combination of abnormal weightbearing distribution and neuropathy secondary to diabetes mellitus in all patients. A retrospective study of diabetic patients from 1984 to 1997 with foot defects reconstructed with a MPA-based flap were reviewed. Thirty-three patients (age 55 +/- 9) with an average tissue deficit of 13 +/- 9 cm2 had MPA reconstruction of the heel (n = 8), midfoot (n = 23), and forefoot (n = 2). The mean follow-up was 19 months (range, 3 months-5 years). There were four minor complications, including marginal flap necrosis or localized infection, although all healed uneventfully. There were six major complications resulting in loss of the flap and proximal amputation. Out of seven patients, there were 12 rerotations of the previously rotated flap. Various techniques for reconstruction of plantar foot defects have been described in the literature. Utilizing glabrous skin for reconstruction of these defects is appealing for its unique shear and pressure-resisting properties. Surgical management of diabetic foot defects with the medial plantar artery flap is an effective means of soft tissue reconstruction.

The modified Lapidus arthrodesis: a retrospective analysis.

The authors present a review of 47 modified Lapidus arthrodesis procedures performed between 1985 and 1995. There were 29 females and 10 males. Eight patients underwent bilateral procedures. The average follow-up was 6.3 years (range, 1.5-10.6 years). The patients were evaluated preoperatively and postoperatively using standard weightbearing radiographs, clinical examination, and chart review. The average preoperative intermetatarsal angle was 13.8 degrees degrees, and the average postoperative intermetatarsal angle measured 2.1 degrees degrees, with a mean improvement of 10.8 degrees. The average effective shortening of the first metatarsal was 4.7 mm in those patients without bone graft. In patients whom bone graft was utilized, an average effective increase in first metatarsal length of 2.6 mm was identified. Complications included delayed union (n = 2), nonunion (n = 3), postoperative development of hyperkeratosis beneath the second metatarsal head (n = 4), elevation of the first ray (n = 3), and hallux varus (n = 2). There were no recurrences of hallux abducto valgus at follow-up. The average return to preoperative activity level was 13 weeks. Forty-two of the 47 procedures healed uneventfully. Of the remaining five feet, two required the use of a bone growth stimulator, and three required revisional surgery with autogenous bone graft to promote arthrodesis and restore alignment. In conclusion, the modified Lapidus arthrodesis is both a predictable and durable procedure for the correction of hallux abducto valgus.

Modified lapidus arthrodesis for adolescent hallux abducto valgus.

The Lapidus arthrodesis was originally described for the surgical correction of hallux valgus associated with metatasus primus adductus. It was popularized on the adult patient with moderate to severe hallux valgus deformity. However, the authors present a retrospective review of 23 adolescents between the ages of 13 and 20 who underwent the procedures. Characteristics of adolescent hallux valgus include a smaller dorsal medial eminence, less valgus rotation of the hallux, and certain mechanical influences. These influences may include a generalized increase in motion at the first metatarsocuneiform joint. The modified Lapidus arthrodesis eliminates motion at the first metatarsocuneiform joint and therefore directly addresses an etiology of the deformity. Both preoperative and postoperative radiographs were evaluated for reduction in the 1-2 intermetatarsal angle. Patients were evaluated through either chart review or telephone interview for present activity level, comfortable footgear, and overall satisfaction of the procedure. Twenty-seven out of 30 feet (90%) had either a good or excellent result with only three complications and two recurrences over a mean follow-up of 61 months.

Prophylactic foot surgery in the diabetic patient.

The preoperative and perioperative evaluation of diabetic foot pathologies has been discussed. The effects of vascular and neuropathic alterations in such cases can be devastating. Only through understanding of the underlying mechanisms that contribute to the diabetic foot can progressive, appropriate care be rendered.

Off-loading techniques in the treatment of diabetic plantar neuropathic foot ulceration.

In the individual with diabetes mellitus, foot ulceration represents the single most important risk factor in lower-extremity amputation. The goal of treatment is to obtain a healed and closed wound that (1) eliminates a portal of entry for bacterial invasion and development of limb-threatening infection, and (2) allows for tissue loading. This manuscript reviews current off-loading approaches to the treatment of plantar neuropathic foot ulcers, along with advantages and disadvantages of those techniques.

The application of allograft bone in foot and ankle surgery.

This article presents a synopsis of the classification, processing, basic physiology, clinical applications, complications, and future direction of allogenic bone implantation. Indications and techniques for the use of allogenic bone in the foot and ankle are thoroughly discussed. Additionally, the advantages and disadvantages of allogenic bone as compared with autogenous bone are reviewed.

Graft-enhanced arthrodesis.

This article reviews the various sites in the foot and ankle where the use of a bone graft to enhance arthrodesis may be indicated. Specific indications are reviewed in detail and demonstrated with clinical examples. Bone graft classification is discussed along with a comparison of autografts and allografts. The controversy surrounding the use of allogenic bone in arthrodesis sites is also thoroughly reviewed. Lastly, this article discusses factors influencing selection of fixation devices and surgical techniques that will promote osseous consolidation and enhance primary union when bone grafts are used in arthrodesis sites.

Elective foot and ankle surgery in the diabetic patient.

The philosophy of treating diabetic foot pathology has changed dramatically throughout the years. No longer are old, unfounded fears considered the standard of care. The authors enumerate on their indications and goals of treating this complex entity. Clinical aids, as well as patient evaluations are discussed.

Arthroscopic arthroplasty of the ankle joint.

Anterior ankle impingement syndrome is characterized by pain, edema, and limited ankle dorsiflexion. The article examines this syndrome in detail from a variety of perspectives, including indications and contraindications, physical examination, various diagnostic modalities, surgical anatomy, surgical approach, procedures for arthroscopy, and complications.