Active clinical trials for "Spondylolysis"

Spondylolysis, a stress fracture in the pars interarticularis of a lumbar vertebra, is the most common identifiable cause of low back pain (LBP) in adolescent athletes, occurring in 14-30% of athletes who experience LBP. Spondylolysis can cause significant pain and disability and months of exclusion from sports or an active lifestyle. Standard care of spondylolysis in adolescent athletes is primarily based on expert opinion, with dramatic variations in clinical practice, including restrictive bracing, extended rest periods before the intervention, long durations out of sport and activity, and suboptimal long-term clinical outcomes. As the next step towards our research goal, the overall objective of this pilot study is to perform a pilot randomized controlled trial to assess a novel rehabilitation strategy, the immediate functional progression program (IFPP), for treating active spondylolysis in adolescent athletes. Participants randomized to the IFPP group will begin physical therapy immediately (<1 week) after diagnosis. In contrast, those in the standard care group (control) will not start physical therapy until their pain has resolved. Aim 1 will evaluate the effects of the IFPP on outcomes (Function, Pain, Quality of Life, and Edema on MRI) among adolescent athletes with an active spondylolysis. Aim 2 will assess the feasibility of performing a full randomized trial using the novel IFPP to treat athletes ages 10-19 with an active spondylolysis. Aim 3 will compare the tolerability of the IFPP to standard care. This pilot study will lay the necessary groundwork to perform a larger hypothesis-driven randomized controlled trial.

The purpose of this study is to collect clinical and radiological mid-term (min. 1 year) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 60 patients.

This research project compares the clinical performance of the cortical bone trajectory CBT insertion technique with the current clinical Gold standard, the Pedicle screw insertion technique. Both techniques are performed by aid of MySpine patient-specific guide systems.

The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.

The purpose of this study is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design.

Low-intensity pulsed ultrasound (LIPUS) is effective in accelerating the healing of fractures, reduction in costs to the state, reduction in the numbers of those patients who progress from out-patient care to long term care who, in the process lose their ability to perform activities of daily living and consequently their independence.

Purpose: To determine the effectiveness of an augmented Pilates program, when combined to a multimodal strengthening program, for patients under the age of 21, who have spondylolysis and/or spondylolisthesis. Significance of the topic: Spondylolysis and spondylolisthesis are often diagnosed in children and adolescents presenting with low back pain. A randomized, clinical trial, test-retest design, with a 3 week and 6 week assessment with functional performance test measures, exercise logs, adherence scale for patient and parent perception, and outcome measures (Global rating of change (GROC) and Modified Oswestry Disability Index (ODI)). This study will attempt to obtain at least 120 subjects that will be randomized into two groups: bracing and a general strengthening program vs. bracing and a Pilates/motor learning program combined with a general strengthening program. This study will begin with an initial examination and continue with treatment sessions 2x/week for 6 weeks. A follow up phone call will be conducted at 3 months after completing the 6-week protocol. The follow up phone call will be an oral conducted GROC and ODI outcome measures.

Lumbar spondylolysis is a relatively common condition that causes severe and perennial back pain in young populations. Conservative treatment of this condition may be futile, and may eventually require surgical treatment such as direct repair of pars defect and a segmental lumbar fusion with an anterior or posterior approach. Recently, of surgical treatment methods for spondylolysis, direct repair surgery of pars defect has been focused due to its inherited strengths. Most importantly, fusion surgery caused the affected segment to lose the nature range of motion and furthermore adjacent segment to be adversely affecting such as adjacent disc disease or degeneration, while direct repair theoretically could preserve the motion of the affected segment, which do not cause the adjacent segment problems as being the fusion surgery, as well as could produce better surgical outcomes with relatively less invasive technique as compared to fusion surgery. Moreover, previous articles have demonstrated that the direct repair surgery for spondylolysis of lumbar spine could achieve great functional and radiological outcomes. However, most of the previous studies was conducted using lower level designed study such as retrospective and small sample size, thereby prior literature does not provide clear information on the therapeutic outcome of direct repair for lumbar spondylolysis, especially for managing spondylolysis of young population. Therefore, The investigators aimed to evaluate and determine the outcomes of direct repair surgery for lumbar spondylolysis in young population. To our knowledge, this is the first report that describes the functional and radiological outcomes of direct repair for spondylolysis in young populations with prospective cohort study design and relatively large sample size.

The purpose of this study is to collect information about how patients feel when doctors manage their pain after lumbar spine surgery using a combination of EXPAREL® and bupivacaine injected into the lumbar spine at the end of surgery, compared to the patients that doctors use only EXPAREL® or bupivacaine to manage their pain. This information will help doctors determine which approach works best for patients who will receive surgery in their lumbar spine in the future.

The goal of the proposed research is to test the feasibility of a functional progression program to reduce cost and possible radiation exposure for adolescent athletes with low back pain. Specifically the investigators plan to test the feasibility of using progression in rehabilitation to pragmatically differentially diagnose and treat adolescent athletes with low back pain, instead of using advanced imaging which is the current practice. The investigators propose to recruit 20 participants, with 10 of usual care (advanced imaging) and 10 of proposed intervention (functional progression) to assess the feasibility of using functional progress to guide treatment. The outcomes measured will be number of days for rest, time to start regular rehabilitation, pain experienced, functional outcomes, ability to return to sport, time needed to return to sport. If this pilot demonstrates the feasibility and a decreased rate of advanced imaging and similar clinical outcomes the investigators plan to progress this work into larger trials.