Clinical Research Directory

Outcomes From Hyperbaric Oxygen (HBO2) Treatment for Emerging Indications

This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The research team hypothesizes that HBOT will result in improvements of the condition of the various emerging indications.

Clinical-instrumental Evaluation and Assessment of Return to Sports Activity in Patients Surgically Treated for Isolated "Stener-like" Lesions of the Medial Collateral Ligament (MCL) or in the Context of Multiligament Injuries and Articular Fractures

The knee is a complex joint stabilized by four main ligaments: the anterior and posterior cruciate ligaments and the medial and lateral collateral ligaments. Multiligamentous knee injuries involve at least two ligaments and usually result from high-energy trauma, causing significant functional limitations. One specific injury is the "Stener-like" lesion of the medial collateral ligament (MCL), characterized by an avulsion at its distal tibial insertion with interposition of tendons from the pes anserinus, which prevents natural healing. This lesion often occurs with other ligament or bone injuries and requires surgical treatment. Diagnosis is clinical, supported by MRI to confirm the distal lesion and tendon interposition. Despite its importance, literature on this injury is scarce, with only a few studies and case reports, often limited by small sample sizes and lack of standardized follow-up assessments. Due to the rarity and complexity of these injuries, there is a need for a comprehensive clinical study with standardized evaluations to improve understanding and develop standardized surgical treatments for isolated and associated Stener-like MCL lesions.

Arthroscopic Versus Open Brostrom for Ankle Instability

Background: Ankle sprains are among the most prevalent lesions in primary care. A substantial number of these ligament lesions will develop ankle instability and require a surgical procedure. The Brostrom-Gould technique is the standard surgical approach for this condition, providing excellent results over the years. Thru the last decades, the arthroscopic Brostrom has gain popularity and support by several studies. Yet, there is no consensus regarding the best procedure to treat ankle instability nowadays. Hypothesis: The arthroscopic Brostrom technique will present better levels of pain and function when compared to the standard open approach. Design: blinded, in parallel groups, multicentric, randomized, clinical trial. Materials and Methods: 98 patients with a diagnosis of chronic ankle instability, referred from primary or secondary health care services, will be assessed and enrolled in this study. Participants will be divided in two groups (randomized by sequentially numbered identical envelopes, which will be administered serially to participants), one containing the open Brostrom repair technique and the other comprehending the arthroscopic Brostrom approach. The assessments will occur in 3, 6, 12, 24 and 48 weeks. Patients will be evaluated primarily by complications and secondarily the Cumberland Ankle Instability Tool (CAIT), American Orthopedic Foot and Ankle Society (AOFAS), the Visual Analogue Scale (VAS), the Foot Function Index (FFI) and the 36 Item Short Form Health Survey (SF-36). The investigators will use Comparison of Two Proportions via relative frequency analysis, the Pearson Correlation the Chi-Square test and the ANOVA for statistical analyses. Discussion: This study intends to establish if the arthroscopic Brostrom technique can produce excellent and reliable results when treating chronic ankle instability. A shorter surgical time, a better cosmetic appearance and a smaller soft tissue injury would support the choice for this procedure if the outcomes could be compared to the open approach.

Evaluation of Outcomes With Umbilical Cord Allograft for Musculoskeletal Conditions Musculoskeletal Conditions

The aim of the study is to determine the efficacy of an Amniotic Fluid Tissue Product for pain relief and functional improvements for all types of musculoskeletal conditions. The study is prospective, with outcome measures being obtained at numerous time points after the regenerative procedure.

Danish Multicenter Scapholunate Ligament Study

Comparison of two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. A randomized multicenter study.