Comparing Ankle Arthrodesis to Ankle Arthroplasty
End-stage ankle arthritis (ESAA) is a debilitating condition associated with severe pain, dysfunction, and reduced quality of life. Many patients with ESAA have difficulty walking for even 100 feet or up a single flight of stairs. Patients seeking surgery for ESAA have two primary treatment options: ankle arthrodesis (i.e., ankle fusion) and ankle arthroplasty (i.e., ankle replacement). Few studies have directly compared the effectiveness of these two procedures, and no randomized controlled trials (RCTs) have been performed. The investigators will compare the following in subjects undergoing ankle arthrodesis and ankle arthroplasty before surgery, and post-surgery at 3 and 6 months, and on an annual basis up to ten years. 1. Overall physical function and ankle specific function 2. Ankle pain intensity and interference with activities 3. Activity levels 4. Overall general health 5. Post-surgical complication rates The investigators will also identify prognostic factors that are predictive of higher physical function, ankle specific function, reduced pain, improved general health, and overall patient satisfaction.
NCT01620541 — Osteoarthritis (OA)
Status: Active, not recruiting
http://inclinicaltrials.com/osteoarthritis-oa/NCT01620541/
Temporal Profile of Serum Vitamin D Levels and Outcomes After Total Ankle Arthroplasty, Ankle Arthrodesis and First Metatarsophalangeal Joint Arthrodesis
Vitamin D is important for bone health and recent research has emphasized the importance of adequate vitamin D levels for bone healing, wound healing, and possibly preventing infections post-operatively. This study will assess the effect of vitamin D supplementation on patient outcomes following ankle arthrodesis or first metatarsophalangeal joint arthrodesis.
NCT04772196 — Ankle Arthrodesis
Status: Enrolling by invitation
http://inclinicaltrials.com/ankle-arthrodesis/NCT04772196/
A Multi-Center, Randomized, Pivotal Study Evaluating AMPLEX Compared To Autogenous Bone Graft in Subjects Indicated for Arthrodesis Surgery Involving the Hindfoot or Ankle
To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in a population indicated for single, double, or triple hindfoot arthrodesis or ankle arthrodesis surgery with supplemental graft material.
NCT03028415 — Arthrodesis Surgery Involving the Hindfoot or Ankle
Status: Completed
http://inclinicaltrials.com/arthrodesis-surgery-involving-the-hindfoot-or-ankle/NCT03028415/
A Multi-Center, Randomized, Pilot Study Evaluating Amplex Compared To Autograft Bone In Foot and Ankle Fusion Surgery
The current research study evaluates an investigational medical device called Amplex B2A(TM) Peptide Enhanced Ceramic Granules ("Amplex") for use in foot and ankle fusion. Amplex is a synthetic bone graft material. The most frequently used graft material is bone collected from the patient (autograft). Autograft involves a secondary incision with the risks of infection and lasting pain. The purpose of this study is to determine if Amplex is a safe and effective alternative to autograft.
NCT01224119 — Arthritis
Status: Active, not recruiting
http://inclinicaltrials.com/arthritis/NCT01224119/
Prospective, Randomized, Controlled, Multi-Center, Pivotal Clinical Trial to Evaluate the Safety and Effectiveness of Augment™ Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions
Study Objective: To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (ABG) in a representative clinical model (foot and ankle fusions) Study Hypothesis: Augment™ Injectable is an equivalent bone grafting substitute to autologous bone graft in applications as shown by superiority analysis for safety and non-inferiority analysis for effectiveness Study Rationale: Evaluate a fully synthetic bone graft material to facilitate fusion in conditions or injuries requiring bone graft in a representative clinical fusion model and thus the opportunity to provide equivalent union rates as ABG without necessitating an additional invasive procedure to harvest the graft
NCT01008891 — Ankle/Hindfoot Fusion
Status: Completed
http://inclinicaltrials.com/ankle-hindfoot-fusion/NCT01008891/
A Radiographic and Clinical Study Evaluating a Novel Allogeneic, Cancellous, Bone Matrix Containing Viable Stem Cells (Trinity Evolution Matrix) in Subjects Undergoing Foot and Ankle Fusion
The purpose of this study is to utilize Trinity Evolution as a graft source in foot/ankle fusions and to follow the subjects to measure the clinical outcomes and fusion rate. The hypothesis of the study is that Trinity Evolution will result in fusion rates and clinical outcomes similar to those obtained from autograft and other routinely used allograft materials; these include: fusion, improvement in pain, improvement in function, and absence of adverse events related to the use of the graft source.
NCT00988338 — Calcaneocuboid Arthrodesis
Status: Completed
http://inclinicaltrials.com/calcaneocuboid-arthrodesis/NCT00988338/
A Randomized Controlled Trial Comparing a Periarticular Injection to a Popliteal Block for Pain Control in Ankle/Hindfoot Osteotomy or Fusion and Ankle Fractures
This study aims to determine the effectiveness and safety of two standard of care perioperative procedures for controlling pain following ankle and hindfoot osteotomy or fusion or ankle fracture repair.
NCT04575688 — Foot Surgery
Status: Enrolling by invitation
http://inclinicaltrials.com/foot-surgery/NCT04575688/
Exparel Use for Popliteal Nerve Block in Postoperative Pain Control; After Ankle Fracture Fixation or Ankle Fusion Surgery: a Case Series
This study involves a drug called Exparel that has been approved by the US Food and Drug Administration (FDA), for application directly to wound sites. EXPAREL® is a long acting pain reliever. It is being given in this study to see if it provides safe and effective pain relief after ankle surgery. Because it is a long acting drug, it may lessen pain relief for as much as 72 hours after surgery. EXPAREL® has not been approved by the FDA for administration by popliteal block, which is the method the study doctors will use to give the patients the drug. Giving the drug by popliteal block involves inserting a small tube in to the back of the knee to deliver the drug. The study doctors wish to determine if patients undergoing ankle surgery and receiving this drug have less pain and less need for narcotic medication.
NCT02072135 — Ankle Fracture
Status: Completed
http://inclinicaltrials.com/ankle-fracture/NCT02072135/
A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment® Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions
STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold standard" (ABG) in a representative clinical model (hindfoot and ankle fusions) STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone grafting substitute to autologous bone graft in applications as shown by non-inferiority analysis STUDY RATIONALE: Evaluate a fully synthetic growth-factor enhanced bone graft substitute to facilitate fusion in conditions or injuries requiring bone graft in a representative clinical fusion model and thus the opportunity to provide equivalent union rates as ABG without necessitating an additional invasive procedure to harvest the graft REGULATORY PHASE: Investigational Device Exemption (IDE) for Premarket Approval (PMA) Application as a bone regeneration system, pivotal phase
NCT00583375 — Foot Fusion
Status: Completed
http://inclinicaltrials.com/foot-fusion/NCT00583375/
Analysis of Patients Who Underwent Ankle Replacement and Simultaneous Subtalar Fusion by Biomechanical and Clinical Evaluation
Subtalar fusion is commonly performed in post-traumatic subtalar osteoarthritis, rheumatoid arthritis, posterior tibial tendon dysfunction, tarsal coalition and primary subtalar osteoarthritis. Patients with osteoarthritis or severe dysfunction involving both the ankle and the subtalar joint may benefit from an tibiotalocalcaneal fusion (TTC) or an ankle replacement and subtalar fusion. With the development of new prosthetic designs and of surgical techniques, total ankle replacements (TAR) became a reasonable alternative to fusion with functional and quality of life improvements. A gait analysis of patients that underwent TAR and simultaneous subtalar fusion allows to study with precision and reliability the ankle range of motion (ROM). On the contrary, in healthy subjects or in patients that underwent isolated TAR this is not possible because the ankle ROM is influenced by the ROM of the subtalar joint in such a way that it is not possible to analyze the two joints separately. Also, excluding the role of the subtalar joint, it is possible to accurately analyze and compare the consequences on ankle kinematics of two different prosthetic designs.
NCT03356951 — Ankle Osteoarthritis
Status: Completed
http://inclinicaltrials.com/ankle-osteoarthritis/NCT03356951/