39 Clinical Trials for Various Conditions
This study is an observational "change from baseline" outcome measures design. Data is collected for the sake of evaluating treatment (fusion surgery) performed as standard medical care, but the investigator does not assign specific interventions to any participants in this study.
To assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib compared to placebo on the first post-operative day in patients with moderate or severe pain following bunionectomy surgery.
The goal of this clinical trial is to determine if performing a lateral soft tissue release during a Chevron osteotomy (or Akin osteotomy when appropriate) for bunions leads to better correction without added complications in 200 patients over the age of 18 years old with the capacity to consent and mild to moderate bunions that are determined to benefit from Chevron osteotomies by one of the IRB approved study physicians. The main questions it aims to answer are: How does the addition of a lateral soft tissue release (LSTR) in a Chevron osteotomy bunion surgery affect hallux valgus alpha angle (HVA) correction? How does the addition of an LSTR in a Chevron osteotomy bunion surgery affect intermetatarsal angle (IMA) degrees of correction? Researchers will compare Chevron osteotomy bunion surgeries with and without LSTR to see if LSTRs lead to better correction without added complications. Participants will: * Be randomized to a control group where they receive a typical Chevron osteotomy bunion surgery or to the experimental group where they receive a Chevron osteotomy bunion surgery with an LSTR. * Complete surveys preoperatively and at 3, 6, and 12 months after surgery. * Receive routine x-rays pre and postoperatively to compare hallux valgus angle (HVA).
Subjects receive study drug during bunionectomy and are followed for pain and opioid use, with the hypothesis that those who receive CPL-01 will have less pain and less opioid use than either control arm.
PRF-110 is a viscous, yellowish clear oily solution of ropivacaine intended for administration into surgical sites to provide post-operative analgesia. The pharmacokinetic profile for PRF-110 suggests that its effect could last up to 72 hours. This is A Phase 3, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study to Evaluate the Analgesic Efficacy and Safety of Intra-operative Administration of PRF-110 Following Unilateral Bunionectomy
This is a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b will evaluate escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 will be a dose-expansion phase to evaluate additional subjects treated with the HTX-034 dose selected based on Phase 1b compared with bupivacaine HCl.
This is a pilot, open label, single center study in 40 subjects undergoing bunionectomy. The study will assess and collect information on pharmacokinetics, pharmacodynamics, safety and efficacy of EXPAREL administered as a sciatic nerve block (in popliteal fossa). A total of 10 subjects will be enrolled in each of the 4 cohorts.
Exparel is an FDA-approved local anesthetic (bupivacaine), in a long-release formulation. In this study the investigators plan to determine the ability of Exparel to control post-operative pain in common first metatarsophalangeal (MTP) joint procedures (bunion surgery, 1st MTP fusion, and cheilectomy).
The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.
This will be a randomized double-blind placebo-controlled clinical trial that will accept all eligible consecutive patients undergoing elective Kalish bunionectomies. Patients will be randomized into either receiving ketorolac (30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days) plus standard of care or placebo plus standard of care. The purpose of this study is to evaluate the effects of ketorolac plus standard of care on post-operative pain control and radiographic osseous healing. Patients will be assessed for pain via a validated pain questionnaire and for delayed unions via a radiographic scoring system shown to have both high inter- and intra-observer reliability by a blinded board certified radiologist. Additional outcomes of bunionectomy procedures will also be evaluated including adverse events and time to regular shoe gear and activities.
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.
This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing bunionectomy.
Orthopedic surgeons frequently prescribe and over-prescribe narcotic pain medications during the postoperative period, despite the ongoing opioid crisis in the United States. While opioid-free multimodal pathways have shown promising results, there remains a lack of published literature evaluating opiate-free multimodal pain protocols for elective outpatient foot and ankle surgeries. This study aims to evaluate post-operative pain following the use of an opioid-free pain treatment plan for patients undergoing foot and ankle surgeries.
Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery. Up to 200 subjects will be treated in this study at up to 20 clinical sites. Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.
This two-part study will be conducted in male and female patients 18 to 65 years of age undergoing bunionectomy. Part I - three-step, single ascending dose study design in which two drug loads (low drug load of funapide and high drug load of funapide) and two volumes (high volume and low volume) of FX301 will be explored against placebo in four cohorts of 12 patients each (9 active:3 placebo) for the management of post-surgical pain in patients undergoing bunionectomy. Part II - expansion cohort to further assess safety, tolerability, systemic exposure, and efficacy of a selected drug load/volume of FX301. An additional 36 patients will be randomized in a 1:1 ratio to receive either FX301 or placebo as a single-injection analgesic nerve block adjacent to the sciatic nerve of the popliteal fossa.
Prospective, randomized, controlled single-blinded trial comparing liposomal bupivacaine with bupivacaine HCl for postoperative management. Upon completion of the forefoot procedure in the operative room the subject will be entered into the randomization system which will specify whether to inject 10cc (5mg/mL) of bupivacaine HCl or 8cc (13.3 mg/mL) liposomal bupivacaine, both considered routine care procedure. Thereafter, postoperative pain will be assessed and measured using a Visual Analog Scale (VAS) scoring scale post-operatively at 2 hours, 24 hours, 48 hours and 72 hours. In addition, the amount of oral morphine equivalents (OME) required postoperatively and time to first use of OME will be measured. Our hypothesis is that patients who received liposomal bupivacaine will have less post-operative pain and require less OMEs.
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
The goal of this research study is to determine the change in frontal plane rotation of the 1st metatarsal from pre to post arthrodesis of the 1st TMT joint with the Phantom® Intramedullary Nail combined with a supinating reduction technique. The study hypothesis is that multi-planar correction can be achieved with the Phantom® Intramedullary Nail.
The objectives of this study are to evaluate the following outcomes of the Lapiplasty® Procedure for patients in need of hallux valgus surgery: * The study will determine the radiographic recurrence of hallux valgus and the timing of failure following hallux valgus correction with the Lapiplasty® Procedure. * The study will determine whether the Lapiplasty® Procedure effectively corrects anatomical alignment of the 1st metatarsal and sesamoids in all three planes. * The study will assess whether early weight-bearing after the Lapiplasty® Procedure affects the union rates or causes loss of 3-plane correction. * The study will evaluate the quality of life and pain scores following the Lapiplasty® Procedure.
Epidemiology of foot and ankle surgeries that present to the hospitals in the US are often underestimated. However there has been growing emphasis on identification of these injuries and practice patterns.
The goal of this research study is to determine if union rates are affected by early weight-bearing after Lapidus Arthrodesis using the Phantom™ Intramedullary Nail. The study hypothesis is that the union rate for those who undergo a Lapidus Arthrodesis procedure with the Phantom™ Intramedullary Nail and participate in an early weight-bearing protocol will be non-inferior to union rates previously published for this procedure.
This study evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy or post-abdominoplasty pain over a 24 hours period. For subjects undergoing bunionectomy, 2 out of 3 subjects will receive Wafermine™ and 1 out of 3 subjects will receive placebo. For subjects undergoing abdominoplasty, 3 out of 4 subjects will receive Wafermine™ and 1 out of 4 subjects will receive placebo.
A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
The purpose of this study is to show the effectiveness of COV155 compared to placebo in subjects with acute moderate to severe pain following bunionectomy surgery.
The primary objective of this study is to show the effectiveness of repeated doses of COV795 versus placebo, using the summed pain intensity difference over the first 48 hours in subjects with acute moderate to severe pain following bunionectomy.
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have had a bunionectomy.
Postoperative pain is usually treated with opioids that have undesirable and sometimes dangerous side effects (e.g., vomiting and respiratory depression)-and yet over 80% of patients still experience inadequate pain relief. A novel, non-pharmacologic analgesic technique-percutaneous peripheral nerve stimulation (PNS)- holds extraordinary potential to greatly reduce or obviate opioid requirements and concurrently improve analgesia following painful surgery. This technique involves inserting an insulated electric lead adjacent to a target nerve through a needle prior to surgery using ultrasound guidance. Following surgery, a tiny electric current is delivered to the nerve resulting in potent pain control without any cognitive or adverse systemic side effects whatsoever. The electrical pulse generator (stimulator) is so small it is simply affixed to the patient's skin. The leads are already cleared by the US Food and Drug Administration to treat acute (postoperative) pain for up to 60 days; and, since percutaneous PNS may be provided on an outpatient basis, the technique holds the promise of providing potent analgesia outlasting the pain of surgery-in other words, the possibility of a painless, opioid-free recovery following surgery. The current project is a multicenter, randomized, quadruple-masked, placebo/sham-controlled, parallel-arm pragmatic clinical trial to determine the effects of percutaneous PNS on postoperative analgesia and opioid requirements, as well as physical and emotional functioning, the development of chronic pain, and ongoing quality of life.
The goal of the study is to gather sufficient patient data to assess real world postoperative function after a first metatarsophalangeal (MTP) joint arthrodesis done in conjunction with first tarsometatarsal arthrodesis (TMT) (double fusion). Many studies have demonstrated the success of a first MTP joint arthrodesis in eliminating pain and reducing the intermetatarsal angle. Very little research has been published to assess the outcomes of double arthrodesis. Limited research has specifically assessed patients' everyday function and gait following MTP arthrodesis and no studies are available to assess real world function following double arthrodesis. More data that includes patient reported function during activities of daily living is needed to understand the benefits and draw backs of combined first MTP/TMT joint arthrodesis used to treat and correct first ray deformity.
This is a Phase 2, open-label, multi-cohort study to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of a single, individualized dose of HTX-011 administered into the surgical site as a monotherapy or with other medications to enhance analgesia in subjects undergoing unilateral simple bunionectomy.
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in subjects undergoing bunionectomy.