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Knee Exam

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1021. Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant Pain

) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Males and Females between 21 and 75 years of age Females must be of non-child bearing potential or practicing birth control Moderate to severe mechanical low back pain OR moderate to severe OA of the hip or knee pain Require medicine for pain the majority of days in the previous 3 months, AND for at least 4 days per week, during the previous 4 weeks. Pain is not controlled with non-opioid analgesics (...) /reconstruction to the index joint OR Arthroscopic or open surgery to the index joint within the last year OR Any surgery within 3 months of study Osteoporotic compression fracture, traumatic vertebral fracture or invasive intervention for low back pain within the last year. Abnormal neurological exam, or lower extremity symptoms characteristic of neurogenic pain History of inflammatory or infectious arthritis, tumors or infections of spinal cord, spinal stenosis, fibromyalgia or other chronic painful

2005 Clinical Trials

1022. Donepezil in the Prevention of Post-Operative Cognitive Decline

to Brief Summary: The purpose of this study is to evaluate the feasibility of using Donepezil to prevent post-operative cognitive decline (POCD) among individuals aged 65 and older who have a baseline mild cognitive impairment (MCI) and are undergoing elective hip or knee replacement. Condition or disease Intervention/treatment Phase Postoperative Complications Delirium Drug: Donepezil Phase 4 Detailed Description: Up to 65% of elderly patients undergoing hip or knee surgery suffer from declining brain (...) are scheduled to have elective hip or knee replacement surgery at University Hospital. Participants will be randomized to receive either a three to six week supply of Donepezil or a matching placebo approximately 4 weeks prior to surgery. This study will evaluate the effect of Donepezil on delirium incidence and severity during hospitalization, global cognitive function, length of hospitalization, site of discharge, and adverse drug effects. All material to be collected will be from interviews

2005 Clinical Trials

1023. Brace Versus Casting in Pediatric Low Risk Ankle Fractures

of returning to normal activities faster, fewer visits to specialty hospital clinics, and significant cost savings. Condition or disease Intervention/treatment Phase Ankle Fracture Device: Below knee walking cast Device: Removable ankle brace Phase 4 Detailed Description: Objective: To determine if a removable ankle brace is at least as effective as casting in children between 5 and 18 years old with low-risk ankle fractures. Rationale: Ankle injuries are very common among children. The Canadian Health (...) Injury Reporting and Prevention Program reports approximately 5500 ankle injuries per year in children presenting to the 16 participating emergency departments, 35% of which are fractures. The majority of ankle injuries in children, including ankle fractures, have an excellent prognosis with a very low risk for any complications. We have recently shown that a predefined structured 'low-risk' clinical exam reliably identifies these low risk injuries, while simultaneously excluding 100% of high-risk

2005 Clinical Trials

1024. The Effect of Botox on Children With Cerebral Palsy

be seizure-free or seizure controlled Children must have visuoperceptual skills and cognitive/communication skills sufficient to follow multiple step commands and to attend to tasks associated with data collection Children's passive range of motion in lower extremity joints must be less than 20 degrees of flexion contracture at the hips as measured by the Thomas Test, at least 20 degrees of hip abduction bilaterally, les than 0 degrees of knee flexion contracture, popliteal angle less than 55 degrees (...) , and at least 0 degrees of ankle dorsiflexion with the knee extended while the foot is in varus Children who are planning to undergo botulinum toxin injections of the gastrocnemius and/or soleus muscles without serial casting as clinically dictated for the treatment of muscle spasticity Exclusion Criteria: Children who have a diagnosis of "mixed" types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia) Children who have had a selective dorsal rhizotomy, are presently are receiving intrathecal

2007 Clinical Trials

1025. A Longitudinal Study of Osteoarthritis (OA) Disease Progression Measured by MRI, dGEMRIC, and Radiography

of the study knee, neuropathic disorders, avascular necrosis, Paget's disease, or tumors (chondrocalcinosis is acceptable; treated thyroid disease is acceptable) Systemic inflammatory diseases (e.g., Rheumatoid arthritis) Other pain that the principal investigator feels can not be distinguished from knee pain (e.g., lumbar pain, hip pain, trochanteric bursitis) Musculoskeletal pain that may preclude the subject from remaining motionless for the MRI acquisitions Unable to undergo an MRI exam of the knee (...) with potentially rapidly progressing OA. The subject population is selected to have higher likelihood of having rapidly progressing OA (i.e., a more rapid joint space narrowing (JSN) compared to general knee OA population and thus, may be more likely to have changes in GAG content and/or cartilage volume. The results of this study may provide a reasonable means to assess DMOAD activity of drugs in development. The non-OA controls are included to determine the rate of change for subjects of similar age. Ideally

2007 Clinical Trials

1026. Magnetic Resonance Imaging to Identify Characteristics of Plaque Build-Up in People With Peripheral Arterial Disease

through a series of timed walks, leg strength exercises, and muscle power exercises. Questionnaires to assess participants' medical history will be completed by each participant's primary care doctor, and study researchers will review participants' medical records. Participants with knee pain will have a knee x-ray, and participants may wear a small device called an accelerometer for 1 week to monitor physical activity levels. During the second and third study visits, occurring at one and two year (...) than 1 in participants Criteria Inclusion Criteria: For participants with PAD: lowest leg ankle-brachial index (ABI) less than or equal to 0.999 For participants in the control group: lowest ABI between 1.00 to 1.30 Exclusion Criteria: Foot amputation, leg amputation, or gangrene Recent liver transplantation Requires oxygen on ambulation End stage renal disease Confined to a wheelchair Lives in a nursing home Low life expectancy Mini-Mental Status Exam (MMSE) score of less than 23 out of 30

2007 Clinical Trials

1027. X-3 Polyethylene Survival Outcomes Study

Radiographs, questionnaires and an exam will be obtained at key post-surgical follow up dates. 3months, 2years, 5 years, 7 years and 10 years. Other Name: Stryker X3 2 X3 Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty. Device: Stryker X3 crosslink Radiographs, questionnaires and an exam will be obtained at key post-surgical follow up dates. 3months, 2years, 5 years, 7 (...) to Brief Summary: A prospective, randomized, blinded clinical trial is proposed to compare Stryker Orthopaedics N2Vac Polyethylene to their X3 Polyethylene when used with the Triathlon Posterior Stabilized (PS) total knee system. Condition or disease Intervention/treatment Phase Arthroplasty, Replacement, Knee Total Knee Replacement Device: Stryker X3 crosslink Phase 4 Detailed Description: This is a fixed-bearing knee intended for use in patients undergoing cemented total knee arthroplasty

2007 Clinical Trials

1028. Clinical Assessment of Two Manipulative Protocols in Treatment of Hip Osteoarthritis

manipulations per protocol 1) with pre-manipulative static and post manipulative active-assisted stretch of hip muscles after each manipulation. Active Comparator: Group B 2) Group B will receive 9 treatments with manipulative therapy treatments (adjustments) to the entire kinetic chain (five areas): the lumbosacral, sacroiliac, hip, knee, ankle and foot joints with pre-manipulative static and post active-assisted stretch of tight hip muscles. There will be a 3, 6 and 9 month follow up. Procedure: Manual (...) / Manipulative Therapy Active comparator will receive 9 treatments of manual or manipulative therapy to the lumbosacral, sacroiliac, hip and knee, ankle and foot joints (HVLA and Grades I-IV mobilization per protocol 2) stretching and exercise.) Supportive Care Supportive Care 3) Groups A and B will receive supportive care after the 9th visit consisting of (up to a maximum of) 6 visits, PRN or as needed, until the 9 month follow up. This is to see if peak gains may be maintained (as noted in the previous

2007 Clinical Trials

1029. Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury

duration of 6 or more months. Muscle tone sufficient to score at least two (2) on the Ashworth Scale for at least one of the following lower muscle groups: ankle plantar flexors (gastrocnemius), knee extensors (quadriceps), knee flexors (hamstrings) and/or hip adductors (adductors) and seven (7) for the most spastic limb. ASIA Impairment Scale Exam score of B, C or D. Female subjects of childbearing potential must be either surgically sterile or using an effective method of contraception. Female (...) or spinous process. Subjects with corrective surgery to or contracture of the measurable hip, knee, or ankle joints. Subjects known to be Hepatitis B or HIV positive. Female subjects who are pregnant or nursing. Subjects who have received an investigational drug within 30 days before Screening visit. Subjects with any documented episodes of seizures. Subjects requiring use of clinically relevant 2C19 or 2D6 inhibitors, or concomitant use of lidocaine. Use of rescue medication(s) within 48 hours

2007 Clinical Trials

1030. COLOMBES Project:Constitution of a Population-based Cohort of Obese Subjects With Longitudinal Long-term Follow-up

Measures : Rate of follow-up at annual visit [ Time Frame: annual ] Secondary Outcome Measures : Assessment of knee arthrosis (pain and radiological exam), at inclusion and after loss-weight (comparison after one and two years of follow-up of patients that did or did not undergo bariatric surgery). [ Time Frame: one and two years of follow-up ] Biospecimen Retention: Samples With DNA plasma, serum, DNA, RNA, cell blood, for persons undergoing bariatric surgery (specific consentment): samples of liver (...) ) with annual follow-up for 10 years. It aims to improve the physiopathological, epidemiological and prognostic knowledge of obesity and its consequences. Clinical data, biological material, exams and questionaires will be collected and stored, allowing the realisation of research works, initiated by research teams from our hospital or from other settings. Condition or disease Obesity Detailed Description: The objective of this observational study is the follow-up of a cohort of 500 adult persons

2008 Clinical Trials

1031. Safety and Efficacy Study of ImCOOH Cream in Patients Suffering From Moderate Atopic Dermatitis

. Finally the Eczema Area and Severity Index (EASI) score will be determined for both target areas, predose on Day 1 of treatment and on Days 7 and 15 of treatment. Safety will be assessed by monitoring (S)AEs, performing clinical laboratory tests (hematology, biochemistry, urinalysis) and physical exams and by taking vital signs and recording ECGs on a regular basis. For pharmacokinetic analysis, plasma concentrations of ImCOOH will be determined on Days 1 and 15 up to 12 hours postdose. In addition (...) (armpits [axillas] are also allowed) or both target areas should be located at the hollows of the knee. Topical Atopic Dermatitis Severity Index (toADSI) score of at least 5 for both target areas and the severity of the 2 sites do not differ by more than 3 points. General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial. Exclusion Criteria: Female subject of childbearing potential without use of effective birth control methods

2007 Clinical Trials

1032. Sleep in Osteoarthritis Project

tests of physical function. Subjects will be also asked to complete additional questionnaire and diary items that ask them to rate their emotions during the pain testing procedures and during the days that they keep their electronic diary for the parent project. At Visit 2, participants will undergo pain testing, an in-home sleep study and optional procedures outlined above. At Visit 3, participants with knee osteoarthritis will have an exam by a rheumatologist. Participants in Phase 1 who have both (...) for insomnia in reducing sleep disturbances, thereby reducing clinical pain in people with knee OA. The study will test whether improvement in clinical pain are mediated by changes in certain types of pain processing. Condition or disease Intervention/treatment Phase Sleep Initiation and Maintenance Disorders Osteoarthritis Behavioral: Cognitive behavioral therapy (CBT) for insomnia Behavioral: Behavioral desensitization treatment for insomnia Phase 2 Detailed Description: Sleep disturbance and pain

2007 Clinical Trials

1033. Education/Exercise and Chiropractic for Chronic Back Pain

: Veterans enrolled to receive VA medical care Current low back pain episode present > 6 weeks. LBP pain score > 3 on scale of 0-10. LBP classified using the Quebec Task Force (QTF) system as types 1-4 respectively, patients with LBP, stiffness or tenderness, without radiation; with radiation proximal to knee; with radiation distal to knee; or with radiation and >2 abnormal neurological exam findings. No change in past month in prescription medications affecting musculoskeletal pain. Exclusion Criteria (...) " session involved a 5 minute exam, 5 minutes of hot pack application to the low back, and 5 minutes of light massage to the low back. During these visits, participants did not receive SMT, mobilization or other active chiropractic treatment. The recruitment goal is to generate the potential to randomize 6-10 participants/month. Recruitment feasibility will be assessed by tracking the number of patients who make initial inquiries, undergo screening and in-clinic evaluation, and are randomized. Further

2007 Clinical Trials

1034. A Pilot MRI Study of Osteopathic Manipulative Treatment of Acute Low Back Pain

below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 55 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion criteria: Adult patients (18-55) Patients with LBP with acute symptoms (within last 3 weeks) Test positive for lumbar somatic dysfunction Exclusion criteria: History of any spinal injuries/surgeries Positive findings of frank neurological signs during physical exam Any other orthopedic (...) or neurological impairment Unsuitable for MRI imaging: Cardiac pacemaker or defibrillator Severe Claustrophobia Injured by a metallic object that was not removed Cochlear (ear) implants Surgery involving a metallic implant (e.g. knee replacement) Weight more than 300 lbs/136 kg (weight limit for scanner bed) Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information

2007 Clinical Trials

1035. Initial Graft Tension and ACL Surgery

. Postoperative visits occurred immediately following surgery and at 6, 12, 36, 60, 84, 120 and 144 months following surgery. Strength testing, functional testing, x-rays, questionnaires, and a knee exam will occur at most postoperative visits. MRIs will occur at some postoperative visits. An additional group of participants with no evidence of knee injury will serve as a control. The control group will attend all study visits except for the 12-month visit. All participants may be followed for up to 10 years (...) ): Braden Fleming, Rhode Island Hospital Study Details Study Description Go to Brief Summary: The anterior cruciate ligament (ACL) is one of four strong ligaments connecting the bones of the knee joint. If overstretched, the ACL can tear. Reconstruction of a torn ACL is now a common surgical procedure. The amount of tension applied to the ACL during reconstruction may indirectly affect the possible onset of arthritis over time. The purpose of this study is to determine the effect of initial graft

2007 Clinical Trials

1036. Classification-Directed Treatment of Low Back Pain

in performance of modified versions of the direction-specific impairment tests from the exam, with an emphasis on impairments that can be modified to eliminate symptoms. Behavioral: Classification-directed treatment People in the Classification-directed treatment will be treated based on their direction-specific LBP classification. Treatment will consist of 3 primary components. The first component of treatment will be analysis and instruction in modification of the person's direction-specific alignment (...) and movement strategies during symptomatic functional activities and activities in which the person uses similar strategies to those displayed with symptomatic functional activities. The second component is education about the principles of tissue injury and healing and the need to keep active. The third component is exercise prescription that consists of practice in performance of modified versions of the direction-specific impairment tests from the exam, with an emphasis on impairments that can

2008 Clinical Trials

1037. Ultrasound and X-ray in Detecting Articular Cartilage Calcification

of ultrasound with a probe superficial performance. 166 patients will be enrolled in this trial and an echography and a radiography of the 2 knees (front and profile) will be done for each patient. Ih the echography show a calcification, further exams with wrists, hips shoulders echographies will be conducted. In case of liquid epanchement, analysis of the liquid will be carried in order to eliminate the differential diagnostic including septic arthritis Study Design Go to Layout table for study information (...) Study Details Study Description Go to Brief Summary: Prospective study with an echography of the 2 knees and radiography of the 2 knees (front and profile) for each patient. If found calcification on ultrasound further examination with ultrasound wrists, hips and shoulders. Condition or disease Intervention/treatment Phase Chondrocalcinosis Articular Cartilage Calcification Procedure: Echography Not Applicable Detailed Description: Osteo-articular echography is currently recognized as an important

2008 Clinical Trials

1038. Effects of Lumbosacral Joint Mobilization/Manipulation on Lower Extremity Muscle Neuromuscular Response

of quadriceps muscles following lumbopelvic joint manipulation. Determine the effects of lumbopelvic joint manipulation on temporospatial parameters of gait such cadence, step length, velocity and mean peak lower extremity joint moments. Determine if a correlation exists between patellofemoral joint pain and lumbopelvic joint dysfunction. Determine the amount of change in clinical outcome measure scores following lumbopelvic joint manipulation. Condition or disease Intervention/treatment Phase Knee Pain Hip (...) of muscle inhibition is multifaceted. Utilization of manual therapy techniques such as joint manipulation or mobilization directed at the lumbopelvic region have been shown to be successful in disinhibiting lower extremity muscles. Previous studies have demonstrated sacroiliac joint manipulation disinhibited the quadriceps muscle in individuals with anterior knee pain. One of the limitations was these studies only observed an immediate decrease of quadriceps inhibition and the duration of the treatment

2008 Clinical Trials

1039. The Effects of Aplindore on the Treatment of Signs and Symptoms of Restless Legs Syndrome

to quality of life and daytime functioning. Recent surveys indicate that RLS occurs in 10% to 15% of the North American population. A common associated feature of RLS is Periodic Limb Movements during Sleep (PLMS). These are repetitive movements that typically occur as flexions of the foot, knee, and hip at intervals of 5 to 90 seconds. Most commonly, the interval is 20 to 40 seconds. The movements are present during non-rapid-eye-movement (REM) sleep and are less common during REM sleep. Population (...) evidence of substance dependence or abuse as defined by DSM-IV criteria; Regular consumption of large amounts of xanthine-containing substances (i.e. more than 5 cups of coffee or equivalent amounts of xanthine-containing substances per day); Self report of the usual consumption of more than 14 units of alcohol per week; Secondary causes of RLS which will be ruled out by physical exam, medical history and clinical chemistries, including serum ferritin; Use of any investigational drug within 30 days

2008 Clinical Trials

1040. Maraviroc in Rheumatoid Arthritis

, but not analyzed. Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ] Change from baseline at each visit was analyzed for tender/painful joint count. Twenty-eight tender and swollen joint scores included the same joints: shoulders, elbows, wrists, metacarpophalangeal joints (MCP), proximal interphalangeal joints (PIP), and the knees. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 tender (...) /painful joint count data were collected, but not analyzed. Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ] Change from baseline at each visit was analyzed for swollen joint count. Twenty-eight tender and swollen joint scores included the same joints: shoulders, elbows, wrists, MCP joints, PIP joints, and the knees. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 swollen joint count data

2007 Clinical Trials

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