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Hallux Valgus clinical trials

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NCT ID: NCT01535144 Completed - Hallux Valgus Clinical Trials

Comparative Study of Osteosynthesis for Chevron Osteotomy of Hallux Valgus Using Degradable Versus Non-degradable Metallic Device

Start date: February 2010
Phase: N/A
Study type: Interventional

The purpose of the study is to show the equivalence of a new degradable metallic device to a non-degradable metallic device in patients with Hallux Valgus.

NCT ID: NCT01516008 Completed - Hallux Valgus Clinical Trials

A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy

Start date: January 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy of at least 1 dose of tapentadol IR 50 mg and/or 75 mg versus placebo using the sum of pain intensity difference at 48 hours (SPID48) to measure analgesic effect in Korean patients with acute pain following bunionectomy.

NCT ID: NCT01501500 Completed - Hallux Valgus Clinical Trials

Effect of Botulinum Toxin to Hallux Valgus in Addition to Total Contact Insole

Start date: August 2010
Phase: Phase 4
Study type: Interventional

The investigators propose a new therapeutic approach by injecting Botulinum Toxin Type A (BTA) to the oblique and transverse heads of adductor muscle of the great toe. BTA works by binding presynaptically to high-affinity recognition sites on the cholinergic nerve terminals and decrease the release of acetylcholine, causing a neuromuscular blocking effect. The investigators hypothesize that BTA injection may help to decrease the hallux valgus angle by decrease adductor hallucis muscle activation. Thereby enhance the therapeutic result of hallux valgus treated with total contact insole. The outcome measurement may shed light in treating patient with painful hallux valgus and document evidence for plantar pressure changes in acute, sub-acute and chronic stage.

NCT ID: NCT01445249 Completed - Hallux Valgus Clinical Trials

Medial Forefoot Block for Analgesia After Foot Surgery

Start date: March 2007
Phase: N/A
Study type: Interventional

Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and is very painful. Local anaesthetic nerve blocks are used to provide pain relief after this work. The purpose of this study is to compare two techniques: one using anatomical landmarks alone to guide local anaesthetic infiltration, the other using peripheral nerve stimulation to guide local anaesthetic infiltration (termed medial forefoot block). The two techniques will be compared for reliability of postoperative analgesia.

NCT ID: NCT01284998 Completed - Hallux Valgus Clinical Trials

Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate

Start date: June 2009
Phase: N/A
Study type: Observational

In case of deformities of the forefoot (Hallux-valgus, Hallux-varus), the basal osteotomy may be more indicated than the distal osteotomy as it allows to achieve a greater degree of correction. However, weight bearing forces on the head of the first metatarsal acting at a distance from the osteotomy site subject the construct to an important dorsiflexion stress. Fixation strength being the important consideration led to design the B-BOP® Lock plate, specifically dedicated to basal osteotomy of the first metatarsal, with the following characteristics: - plantar positioning to obtain the best stability and resistance while reducing the implant bulkiness; - anatomical shape adapted to the plantar curve of the first metatarsal. Taking advantages of the most appropriated anatomical site to implant the B-BOP® Lock plate directly on tension, it offers an innovative and unique basal osteotomy fixation solution. The B-BOP® Lock osteosynthesis plate benefits now of the Surfix locking screws technology. The purpose of this study is to collect and publish data from several centers, several users.

NCT ID: NCT01284985 Completed - Osteoarthritis Clinical Trials

Short Term Follow-up of Patient Implanted With the Metatarso-Phalangeal Prosthesis METIS®

Start date: February 2009
Phase: N/A
Study type: Observational

The great toe is vital for normal, pain free ambulation. Decreased function associated with osteoarthritis of the first matatarsal phalangeal joint (MTP I) often called Hallux Rigidis or Hallux Limitus leading to a painful great toe. Patients experience pain during ambulation especially during the push-off phase of gait. When surgery is indicated four techniques are used for hallux rigidis; cheilectomie, resection arthroplasty, arthrodesis and implant surgery (1). Endoprostetic implants are relatively new. Silicone Implants like the arthroplasty developed by Swanson (2) resulted in foreign body reactions and periarticular bone loss. Subsequent implants, in particular the metallic hemi arthroplasty with or without polyethylene articulations, have been more successful (3). Still, implants are prone to wear of the material and show higher rates of loosening and infection compared to other techniques (4;5). In the last decades several new implants are described using two non cemented pressfit components, of titanium alloy or ceramic (6-9). Between 2001 and 2004 the investigators developed a new concept with instrumentation for exact alignment to prevent for wear with loosening of the implant on the long term. The implant has bone-conserving characteristics to enable arthrodesis as a salvage procedure. It is a completely modular two-component press fit titanium alloy implant with polyethylene insert that can be used as either for hemi-, total- or revision arthroplasty. The purpose of this study is to have an overview of clinical status of the patient implanted with the METIS® prosthesis at short term (2 years of follow-up). The objective of this study is to evaluate the safety and efficacy of the Metatarso-Phalangeal prosthesis METIS® at short term follow up.

NCT ID: NCT01190722 Withdrawn - Postoperative Pain Clinical Trials

A Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain

Start date: November 10, 2010
Phase: Phase 4
Study type: Interventional

The investigators hypothesize that cyclooxygenas-II-selective inhibitors (Coxibs) provide a better patients assessed overall satisfaction when used for pain management after elective hallux valgus surgery as compared to traditional Non-steroidal anti-inflammatory drugs (NSAIDs).

NCT ID: NCT00890682 Completed - Hallux Valgus Clinical Trials

Study of Postoperative Analgesia in Bunionectomy

Start date: April 2009
Phase: Phase 3
Study type: Interventional

After undergoing bunion surgery, patients are given a pain medicine injection that may last for up to several days or a placebo. Their pain and pain medicine use is then monitored.

NCT ID: NCT00733421 Completed - Postoperative Pain Clinical Trials

The Effect of Anti-inflammatory Analgesics on Pain Following Hallux Valgus Surgery

Start date: October 2008
Phase: Phase 4
Study type: Interventional

The effects of none-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase inhibitors (Coxibs) on the formation of bone and fracture healing have been a matter of debate since long. There is, however, limited data in humans and further prospective randomised studies are warranted. Ekman et al studied in a prospective randomised double blind study the effects of celecoxib, a selective cox-II-inhibitor, on pain and bone healing following spine surgery. They found significant effects on reduction of pain and need for opioid analgesics postoperatively but could see no negative effects the numbers of "none-unions" at a 1-year follow up 3. In a similar prospective randomised double-blind study design significant effects in reduction of pain and need for rescue analgesia was seen from the use of celecoxib in the perioperative multi-modal pain strategy for cruciate-ligament reconstruction and no negative effects could bee seen on six month follow-up of the strength of the reconstructed ligament. The aim of the present study is to further study the effects of the perioperative use of etoricoxib, a selective cox-II-inhibitor (Coxibs), in a prospective randomised double-blind study on bone healing, pain and need for rescue analgesia in patients undergoing elective Hallux Valgus surgery with a standardised surgical technique including an osteotomy of metatarsale I and excision of exostosis. Study population 100 American Society of Anesthesiology (ASA) physiological status1-2 patients scheduled for elective hallux valgus (HV) surgery The patients are going to be randomised into 2 groups, 50 patients in each; 1. etoricoxib 90 mg once daily x 5 2. tramadol 100 mg twice daily x 5 First line rescue medication t. paracetamol 1 gr up to 4 gram daily Second line rescue t. oxycodone 10 mg Primary study variables: - X-ray evaluation (computer tomography (CT)-investigation) of bone healing assessed a CT-scan modelling of the osteotomy at twelve weeks after surgery - Number of patients requiring rescue medication - Patient assessment using "brief pain inventory" 24 hours and 2 weeks after surgery Secondary study variables are; - Visual Analogue Scale (VAS) grading Day 1-7 - Compliance to base medication - Need for rescue analgesia Day 1-7 - Adverse Effects - Experience of any emetic symptoms - Experience of any gastrointestinal symptoms - Satisfaction with pain medication Day 20 - Wound dressing Day 20 - Clinical evaluation 17 weeks, final assessment

NCT ID: NCT00683137 Completed - Pain Clinical Trials

Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery

Start date: October 2002
Phase: Phase 3
Study type: Interventional

The study was done to evaluate the pain relief and safety of 2 valdecoxib doses compared to placebo in patients with moderate or severe pain following bunionectomy surgery, and to evaluate the effect of the 2 valdecoxib doses compared to placebo on health outcome measures and on the occurrence of opioid related symptoms.