Clinical Research Directory

KT Tape for Pediatric Clavicle Fractures

Clavicle fractures in children are mostly managed non-operatively since they have an overall high union rate (95%) and a "good" functional outcome following nonoperative treatment. However, the downside of such a conservative approach is that patients have to live with pain and disability until the fracture heals. To minimize this, fractures are usually immobilized with a sling. There have been no studies looking at clavicle fractures treated with kinesiology (elastic) tape. No adverse effects (skin irritation, redness, etc.) are observed with the application of this tape. Elastic tape has previously been examined regarding muscular advantages rather than for healing fractures. Since this tape should immobilize fractures better than a sling, patients should experience less pain and disability associated with their fracture.

Descriptive Single-center Retrospective Study of a Series of Cases of Clavicle Pseudarthrosis: Epidemiology, Surgical Management, and Functional Outcomes

1. Study identification Study title: PSEUDO-CLAV - Single-center retrospective descriptive study of clavicle nonunion (pseudarthrosis): epidemiology, surgical management, and functional outcomes PSEUDO-clav\_Notice non oppositi… Study type: Observational study (retrospective, single-center) using existing medical records and imaging Study sponsor / data controller: CHU de Brest Scientific lead (principal investigator): Dr Agathe YVINOU (Orthopaedic \& Trauma Surgery, CHU de Brest) Data Protection Officer (DPO) contact: protection.donnees@chu-brest.fr 2. Why is this study being done? A clavicle nonunion (pseudarthrosis) is when a broken collarbone does not heal as expected and may cause pain, reduced shoulder function, and lower quality of life. Surgery is often used, but because this condition is uncommon, the investigators want to better understand: who is affected, which surgical strategies are used, how often the bone heals after surgery, what functional recovery and complications look like in real-life practice. 3. Goal of the study (use/keep this "fill-in" format) The goal of this observational study is to describe clavicle nonunion cases treated surgically at CHU de Brest and to estimate how often the clavicle heals after surgery, using information already collected during routine care. The main questions it aims to answer are: How often does the clavicle heal ("consolidate") after surgery? Main measure: union rate at \~6 months after surgery (assessment window approximately 4-8 months). PSEUDO-clav\_Protocole\_scientifi… How do patients recover in terms of function and symptoms, and what complications occur? Examples: shoulder function scores (Constant and/or DASH), pain, return to work/sport, complications and re-operations. PSEUDO-clav\_Protocole\_scientifi… If there is a comparison group (optional wording): Researchers may compare different surgical strategies (for example, plate fixation alone vs. plate fixation plus bone graft, and other techniques when used) to explore whether results differ for healing, recovery, or complications. PSEUDO-clav\_Protocole\_scientifi… 4. Who may be included? (participant population) This study may include adults who: were treated at CHU de Brest, and had surgery for clavicle nonunion between January 1, 2000 and December 31, 2024, and were 18 years or older at the time of the nonunion surgery, and have enough information in the medical record/imaging to evaluate outcomes. PSEUDO-clav\_Protocole\_scientifi… Estimated number of participants: up to about 30 cases in this center (because the condition is rare). PSEUDO-clav\_Protocole\_scientifi… 5. What will participants have to do? Nothing extra. This study: uses existing information already in the medical record and imaging systems, involves no additional visits, no extra tests, and no change to treatment, and does not require direct contact with patients. 6. What information will be used? Information may include (examples): medical history related to the injury and health conditions, details of the surgery (type of fixation, whether a bone graft was used), lab results (including microbiology if relevant), radiology/imaging reports and images, follow-up notes about pain, function, healing, complications, and re-operations. 7. Risks and benefits Risks to for the patients : Since no new procedures are done, the main risk is related to privacy/confidentiality of data. The study team puts protections in place to reduce this risk (see below). Benefits: the patients should not expect a direct personal benefit, because care is not changed. Results may help improve understanding of clavicle nonunion surgery, follow-up practices, and future care decisions. 8. How will privacy be protected? Data used for analysis will be pseudonymized (coded). Name and first name are not included in the research dataset. Only authorized members of the research team can access the data, using secure access (e.g., password-protected files and restricted hospital systems). Study results will be presented as grouped data, so individuals cannot be identified in publications or conference presentations. Data retention: research data are kept and archived for a limited duration (e.g., up to 5 years after the end of the study, per the study documentation). 9. Voluntary nature and patient's rights Because this is a retrospective study using existing records, participation is based on non-opposition (opt-out). The patient can: object to the use of data for this study, and request access, correction, or limitation of processing as permitted by data protection rules. How to object (opt out) of PSEUDO-CLAV: Email the DPO: protection.donnees@chu-brest.fr, or use the CHU Brest transparency portal (as listed in the notice), or contact the study scientific lead, or write to CHU Brest (address listed in the notice). Choosing not to participate will not affect patient's medical care now or in the future

A.L.P.S. Clavicle Plating System PMCF

A commercially available product clinical study which aims to confirm the safety, performance, and clinical benefits to the patient of the ALPS Clavicle Plating system for both the implant itself and the instrumentation used during surgery.

Randomized Study of an Analgesic Device Enabling Local Anesthetic Delivery and Neuromodulation After Shoulder/Foot Surgery

Postoperative pain remains undertreated with inadequate analgesic options. Opioids have well-known limitations for both individuals and society; single-injection and continuous peripheral nerve blocks provide intense analgesia but are limited in duration to 24-72 hours; and current neuromodulation options-with a duration measured in weeks and not hours-are prohibitively expensive and require an additional procedure. One possible solution is a device currently under investigation to treat postoperative pain. The RELAY system (Gate Science, Moultonborough, New Hampshire) is comprised of a basic catheter-over-needle device to allow administration of a single-injection of local anesthetic via the needle (or catheter) followed by a perineural local anesthetic infusion via the remaining catheter (when desired). Subsequent to the local anesthetic administration, instead of removing the catheter as with all previous continuous peripheral nerve block equipment, electric current may be delivered via the same catheter and an integrated pulse generator for up to 28 days. This is potentially revolutionary because it would allow an anesthesiologist to deliver (1) a single-injection peripheral nerve block; (2) a continuous peripheral nerve block; and (3) neuromodulation using a single device that can theoretically be placed in the same amount of time required for a single-injection peripheral nerve block. Instead of providing fewer than 24 hours of postoperative analgesia, up to 28 days of pain control could be delivered without disruption of existing practice patterns. The ultimate objective of the proposed investigation is to investigate the post-operative analgesic potential of this investigational device and prepare for a pivotal multicenter clinical trial.

The Scandinavian Displaced Lateral Clavicle Trial

A multicentre multinational RCT to investigate whether non-surgical treatment is non-inferior to surgical treatment for displaced extraarticular lateral clavicle fractures in adults.

Digital Aftercare for Wrist and Clavicle Fractures

This prospective, two-arm, open-label clinical trial compares digital aftercare with traditional follow-up in adult patients after surgical treatment of uncomplicated distal radius or clavicle fractures. The primary objective is to assess functional recovery at three months, using the Patient-Rated Wrist Evaluation (PRWE) for wrist fractures and the QuickDASH for clavicle fractures. Secondary outcomes include range of motion, patient satisfaction, quality of life, complication rates, healthcare costs, and work disability. In the digital aftercare group, program adherence and user experience will also be evaluated through app usage data and a structured questionnaire. The study aims to determine whether digital aftercare is a clinically and economically equivalent alternative to standard in-person care.

Multi-Center Adolescent Clavicle Fracture Trial: Operative vs. Non-Operative Treatment

Investigators from eight tertiary care, level 1 pediatric trauma centers have developed a protocol for the establishment of a formal, prospective multi-center adolescent clavicle registry, with designs for standardized radiographic assessment and the prospective collection of validated outcome measures and complications data, for all patients, ages 10-18, treated for clavicle shaft fractures, operatively and non-operatively. Eventually, the investigators would like to do comparative analysis for the operative and non-operative treatment arms, with additional sub-stratified analyses performed within these treatment arms by age and activity level. Among the primary goals of research projects stemming from the first arm of this registry, FACTS A, is to explore the hypothesis that non-operative treatment is associated with lower costs, greater safety, and equivalent or superior outcomes, compared with operative treatment, despite a national trend towards increasing surgical treatment. The second arm of the registry, FACTS B, will continue to investigate the same hypotheses, excluding cost outcomes, in patients only with completely displaced midshaft clavicle fractures.

Crossed Education in Relation to Muscle Mass in Patients Operated of Clavicular Fracture

The immobilization process after an operation or injury in the upper extremity causes a loss of muscle mass and strength of 0.2% and 1.3% per day, respectively. Currently, the use of cross-education, which is unilateral training in the uninjured limb, during the immobilization period, is expanding, demonstrating a magnitude of strength gain in the immobilized limb from 8% to 77% of the mean of strength of the trained limb. Despite the evidenced benefits of cross-education in unilateral injuries such as distal radius fracture, anterior cruciate ligament injury, and knee replacement, very little is known about this effect in shoulder immobilization after clavicle fracture.

Cervical Plexus Versus Infiltration for Clavicular Operations (CERPICO)

Clavicle fractures are the most common fracture of the shoulder girdle, with young men being the most affected demographic. The incidence of clavicle fracture among military service members is 1.5-3x higher than the general adult population. While many clavicle fractures may be managed non-operatively, surgical intervention for clavicular fractures has shown improved functional outcomes in the active-duty Marine Corps population and an overall satisfactory return-to-duty rate. However, surgical fixation of the clavicle is associated with significant postoperative pain when no local anesthetic techniques are employed. Several regional anesthetic and local infiltrative analgesic regimens have been studied to improve postoperative pain control for clavicle ORIF with the authors concluding that intermediate cervical plexus block is the regional anesthesia therapy of choice for post-operative analgesia. A retrospective study by the same group determined that an intermediate cervical plexus block resulted in lower postoperative pain scores and opioid requirements than surgeon-administered local infiltration analgesia. This retrospective study unfortunately lacked participant blinding, randomization, a standardized anesthetic, consistent block technique, and protocolized postoperative analgesia. To date, no prospective trial has been performed directly comparing these two techniques. We propose, given the significance of clavicle fractures and corrective surgery in the military population, to study the efficacy of ultrasound-guided intermediate cervical plexus blocks as compared to local infiltration analgesia.

Comparison Between Clavipectoral Fascia Block & Interscalene Brachial Plexus Block as Regard Adequacy of Anesthesia in Clavicle Surgeries

A newer technique called clavipectoral fascial plane block (CPB), introduced by Valdés-Vilches in 2017, involves injecting local anesthetic under ultrasound guidance between the clavipectoral fascia and periosteum at the injury site. This method offers a promising alternative for effective regional anesthesia in clavicular fracture surgeries. this study is aim to Comparison Between Use of Ultrasound guided Clavipectroal fascia block ( CPB ) \& interscalene brachial plexus block ( ISBP ) As Regard Adeqacy of Anesthesia in clavicle Fracture

Comparing Dual Mini-fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures Trial

The rate of surgical fixation of fractures of the collarbone (i.e., midshaft clavicle) has exponentially increased in recent years; however, the rate of repeat procedures for removal of these implants (i.e., plates) due to irritation remains high. Despite technological advances in implant design, nearly one in four patients with a surgically fixed collarbone ultimately undergoes removal of their implant. More recently, there has been a growing body of literature demonstrating the effectiveness of using two smaller caliber plates, which have been found to have similar rates of implant removal. As such, the proposed randomized clinical trial seeks to be the first level I study to directly compare dual mini-fragment plating of acute displaced midshaft clavicle fractures to single precontoured plating. The investigators hypothesize that dual mini-fragment plating will result in lower rates of reoperation with similar rates of union and complication.