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2016| April-June | Volume 1 | Issue 2
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May 31, 2016
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STUDY PROTOCOL
Isometric muscle strength as a predictor of one repetition maximum in healthy adult females: a crossover trial
Manisha Parai, Pramod Divakara Shenoy, Shalini Velayutham, Choo Kian Seng, Charmaine Yip Fung Yee
April-June 2016, 1(2):71-78
DOI
:10.4103/2468-5674.183005
One repetition maximum (1RM) and maximum voluntary contraction (MVC) with a digital dynamometer are popular methods of measuring muscle strength. The types of muscle contraction involved in both are different, 1RM involves isotonic muscle contraction (ITMC) and MVC with a digital dynamometer involves isometric muscle contraction (IMMC). There are several risks involved in measurement of 1RM, such as delayed onset muscle soreness and being unsafe for pathological joints, all of these can be reduced if we use IMMC in measuring muscular strength. Both cannot be equated as they are different types of contraction, therefore the purpose of this study was to compare and find a relationship between 1RM measurement and isometric MVC in healthy females. Twenty-nine young females (mean age = 20.77 ± 1.28 years) without any weight training experience (mean body mass index = 20.43 ± 1.85) volunteered to participate in the study. It was a crossover trial where 48 hours of rest period was given between each measurement technique. Results showed moderate correlations (
r
= 0.365-0.847) between 1RM and MVC. A simple linear regression analysis revealed a significant estimated regression equation for dominant and non-dominant sides [dominant,
Y
= 0.391
X
+ 1.472; non-dominant,
Y
= 0.251
X
+ 2.629 (
Y
: 1RM,
X
: Isometric)] with low standard error of estimate (dominant, 0.74; non-dominant, 0.80). Results also showed no significant difference between these derived equations and Brzycki 1RM prediction equation. Both prediction equations can be used interchangeably to predict the muscle strength of a healthy female, and thus IMMC can be used to predict 1RM in healthy females.
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Treatment of intertrochanteric femoral fracture with proximal femoral medial sustainable intramedullary nails: study protocol for a randomized controlled trial
Peng-bin Yin, An-hua Long, Jing Shen, Pei-fu Tang
April-June 2016, 1(2):44-50
DOI
:10.4103/2468-5674.183001
Background:
Conservative management of intertrochanteric femoral fracture often yields poor therapeutic outcomes, and surgical fixation is generally warranted. Biomechanical instability of intertrochanteric femoral fracture is a major cause of fixation failure. To increase the stability of intramedullary nails in intertrochanteric femoral fracture, it is critical to strengthen the support between the nail and the cortical bone. Our previously designed proximal femoral medial sustainable intramedullary nail has been proven to be able to provide this internal support and stabilization by finite element analysis. We aim to examine the efficacy and safety of internal fixation with this new type of intramedullary nail in the treatment of stable and unstable intertrochanteric femoral fractures.
Methods/Design:
This will be a single-center, two-arm, parallel, randomized controlled trial conducted at the Chinese PLA General Hospital, China. Seventy-two patients with stable or unstable intertrochanteric femoral fracture diagnosed according to AO/OTA Classification of Fractures and Dislocations will be randomly assigned to receive internal fixation either with proximal femoral medial sustainable intramedullary nails, or proximal femoral nail antirotation. The primary outcome measure will be bone healing condition 6 months postoperatively; secondary outcomes will be requirement for revision surgery, quality of life and complications 1 year postoperatively.
Discussion:
Our findings will provide an evidence base for the use of proximal femoral medial sustainable intramedullary nails for the treatment of intertrochanteric femoral fracture.
Trial registration:
ClinicalTrial.gov identifier: NCT01437176; registered on 1 September 2011.
Ethics:
This protocol was approved by Ethics Committee of Chinese PLA General Hospital of China (approval No. 07/06/2011) and will be performed in accordance with the
Declaration of Helsinki
formulated by the World Medical Association.
Informed consent:
Written informed consent will be obtained prior to involvement in the clinical trial.
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13,277
1,115
2
Lateral dislocation of the elbow: a report of two cases and literature review
Ganesh Singh Dharmshaktu, Aanshu Singhal
April-June 2016, 1(2):79-82
DOI
:10.4103/2468-5674.183006
Elbow dislocation is the most common dislocation, but most elbow dislocations are posterolateral or posterior. Pure lateral elbow dislocation is rare and often under recognized. It is necessary to assess the radiographic status and clinical features for diagnosis and appropriate management of pure lateral elbow dislocation. The position of the affected extremity at the time of injury and the characteristics and impact of forces over the injured part determine the pattern and direction of subluxation/dislocation of the elbow. We reported two adult cases of lateral elbow dislocation who received closed reduction, splinting and supervised physiotherapy. Lateral ligament complex injury was also managed conservatively. Good functional outcomes with evident limitation of movement were obtained during the follow-up period. No residual instability or re-dislocation was noted.
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Minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws for repair of distal radius fracture: study protocol for a randomized controlled trial
Zhi Li
April-June 2016, 1(2):58-63
DOI
:10.4103/2468-5674.183003
Background:
Conventional open reduction internal fixation and external fixation are not ideal treatment options for distal radius fracture. Minimally invasive surgery for distal radius fracture results in less trauma than other techniques; fully threaded headless cannulated compression screws can increase the stability of fracture fragments and contribute to functional recovery after wrist fracture. In this proposed study, we hypothesize that minimally invasive closed reduction and internal fixation of distal radius fracture with fully threaded headless cannulated compression screws will promote functional recovery of the wrist joint.
Methods/Design:
In this prospective, randomized, controlled trial, we will recruit 60 outpatients with distal radius fracture from the Department of Orthopedic Surgery, Central Hospital Affiliated to Shenyang Medical College, China. Patients will be assigned to one of two treatment groups: C-arm fluoroscopy-assisted minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws (experimental group) or open reduction (palmar and dorsal incisions) and internal fixation with titanium plate (control group). Internal fixation will be maintained for 24 weeks in both groups. Our primary outcome measures will be X-ray and CT examinations 24 weeks after surgery. Secondary outcome measures include patient-rated wrist evaluation scores, used to evaluate wrist joint function; fracture healing time; and Visual Analogue Scale score, used to evaluate the severity of the patient's pain.
Discussion:
With this study we hope to confirm that minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws for distal radius fracture repair has advantages over conventional open reduction internal fixation with titanium plates, providing superior fragment stability and allowing for early rehabilitation exercise of the wrist joint, which improves recovery of function. We hope to show that minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws is the more suitable surgical method for repair of distal radius fracture.
Trial registration:
ClinicalTrial.gov identifier: NCT02784678.
Ethics:
The study protocol was approved by the Ethics Committee of Central Hospital Affiliated to Shenyang Medical College, China. The trial protocol will be performed in accordance with the guidelines of the
Declaration of Helsinki
, formulated by the World Medical Association.
Informed consent:
Prior to the trial, patients and their family members will be informed of the risks and benefits of this trial. Signed informed consent will be obtained from each patient.
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11,812
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2
Minimally invasive treatment of proximal humerus fractures with locking compression plate improves shoulder function in older patients: study protocol for a prospective randomized controlled trial
Tao Wu, Guo-qiu Zhang
April-June 2016, 1(2):51-57
DOI
:10.4103/2468-5674.183002
Background:
Manual reduction or traditional steel plate fixation is commonly used for repair of proximal humerus factures in older patients, making these injuries prone to fracture malunion because of poor stability. While open reduction with steel plate fixation has a better outcome than closed reduction, the stability of internal fixation is still less than satisfactory. Therefore, we hypothesize that use of a locking compression plate will provide better stability and that biocompatibility will potentiate fracture healing and shoulder function recovery in older patients with proximal humerus fractures. This hypothesis is based on the fact that minimally invasive treatment with locking compression plates has presented good clinical results in terms of fixation stability, bone healing, and functional recovery.
Methods/Design:
This prospective, single-center, randomized controlled clinical trial will be completed at the Department of Joint Surgery, Affiliated Hospital of Qinghai University in China. Eighty-two older patients with proximal humerus fractures will be enrolled and equivalently assigned to two groups. In the test group, patients will undergo closed reduction
via
a lateral approach to the shoulder followed by locking compression plate fixation using a minimally invasive technique, and those in the control group will be subjected to closed reduction
via
a lateral approach to the shoulder followed by conventional steel plate fixation using a minimally invasive technique. All patients will be followed up for 6 months. The primary outcome will be recovery of shoulder function as indicated by clinical outcome scores according to the Neer classification system for proximal humeral fractures 6 months after surgery. The secondary outcomes will include the operation time; intraoperative blood loss; postoperative hospital stay; fracture healing time; clinical outcome scores according to the Neer classification system 0.5, 1, and 3 months after surgery; Visual Analogue Scale scores 1 and 3 days and 1 and 2 weeks after surgery to assess pain; scores of the Medical Outcomes Study 36-item Short Form Health Survey 0.5, 1, 3, and 6 months after surgery to assess quality of life; and X-ray examinations 0.5, 1, 3, and 6 months after surgery to assess fracture healing.
Discussion:
This study protocol represents an attempt to objectively choose appropriate methods for internal fixation of proximal humerus fractures in older patients by comparing locking compression plate with conventional steel plate fixation to improve shoulder function.
Trial registration:
ClinicalTrial.gov identifier: NCT02784522.
Ethics:
This study acquired written approval from the Ethics Committee of the Affiliated Hospital of Qinghai University in China (approval No. QHY1005D); this study will be performed in accordance with the guidelines of the
Declaration of Helsinki
, formulated by the World Medical Association.
Informed consent:
Written informed consent will be obtained prior to involvement in the clinical trial.
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10,615
1,068
2
Commentary on "femoral nerve block prevents deep venous thrombosis of the lower extremity after knee arthroplasty: a single-center randomized controlled trial"
Brian Wu, Ido Badash
April-June 2016, 1(2):83-84
DOI
:10.4103/2468-5674.183007
Total knee arthroplasty (TKA) is the most frequently performed surgical remediation for patients with long-standing osteoarthritis, but a variety of negative outcomes following TKA have been noted, including deep vein thrombosis (DVT). It is the aim of Chen et al.'s randomized controlled trial to explore the efficacy of advanced ultra-sounded guided femoral nerve blocks for reducing serum inflammatory cytokine levels associated with DVT. By specifically measuring changes in neurtrophil elastase following use of either an advanced femoral nerve block 30 minutes prior to surgery or conventional femoral nerve block after surgery and intravenous analgesia, Chen et al.'s study will elucidate the most reliable method for preventing DVT occurrence after TKA. While this commentary identifies several limitations to the study that must be addressed, the sound study design, adequate number of participants and the potential impact of the work on improving patient outcomes from a common procedure make it a valuable contribution to the field of orthopedics. With conclusive results from this study, as well as additional studies investigating the benefits of advanced femoral nerve blocks on outcomes like muscle atrophy, the procedure could become an important consideration during TKA surgery.
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The best modern practices to reduce surgical complications after total hip and knee replacement
Amal Elramli, Abdelhaq Elmansori
April-June 2016, 1(2):85-87
DOI
:10.4103/2468-5674.183008
Although there is the use of pharmacological prophylaxis to prevent venous thromboembolic diseases after total hip or knee replacement, venous thromboembolism is considered one of the main and serious complications. Moreover, the incidence of deep venous thrombosis among the patients who have total hip or total knee replacements is still high. The use of regional anaesthesia in arthroplasty has been increasing recently. In addition to its effects in elimination pain, regional anaesthesia may help to reduce the incidence of postoperative thromboembolism. Given this, this paper aims to highlight the role of regional anaesthesia to improve outcomes of hip and knee arthroplasty.
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Consistency of microbiological and pathological tests between infected bone and surrounding deep soft tissues in diabetic foot osteomyelitis: study protocol for a single-center, self-controlled, open-label trial
Jun Xu, Peng-hua Wang, Xue-mei Li, Shu-hong Feng, Min Ding, Xi-wen Li, Wei-jie Yao, Zi-xi Zhao
April-June 2016, 1(2):64-70
DOI
:10.4103/2468-5674.183004
Background:
Diabetic foot osteomyelitis is a mixed bone infection, and early detection and treatment can avoid unnecessary amputation and improve patient survival. However, determining an accurate diagnosis is a difficult and commonly encountered challenge. Most patients fail to exhibit any overt symptoms or hematological characteristics despite the presence of a severe limb infection. The most commonly used clinical standard for diagnosis is histological and microbiological examination of the bone tissue. However, such examinations are not feasible in all patients suspected to have diabetic foot osteomyelitis, and many affected patients have an insufficient understanding of the need to repeatedly collect bone samples and thus exhibit poor compliance. Further, the proper use of antibiotics in the treatment of diabetic foot osteomyelitis is severely hampered by the difficulty of diagnosis. Considering that patients often develop soft tissue infection followed by bone infection, we assume that the histological and microbiological findings of bone tissue are consistent with those of the deep soft tissue around the bone infection. In this study, we will explore whether deep soft tissue specimens are an alternative to bone tissue specimens in histological and microbiological tests for the clinical diagnosis of diabetic foot osteomyelitis.
Methods/Design:
A prospective, single-center, self-controlled, open-label trial will be completed at Tianjin Metabolic Diseases Hospital of Tianjin Medical University in China. A total of 200 patients with diabetic foot osteomyelitis, aged 18 to 80 years, of both sexes, and admitted as outpatients from 1 April 2015 to 30 June 2016 will be recruited and subjected to histological and microbiological examinations of infected bone and surrounding deep soft tissue. The primary outcome will be the sensitivity and specificity of microbial cultures of infected bone and surrounding deep soft tissue at admission for diabetic foot osteomyelitis. The secondary outcomes will be blood biochemical indices, X-ray characteristics of the affected foot, and the blood supply of the affected lower limb. Findings from the microbial cultures of bone and deep soft tissue will be used to calculate the positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio for the diagnosis of diabetic foot osteomyelitis. We will therefore be able to verify whether the histological and microbiological tests exhibit consistent results between infected bone and surrounding deep soft tissue.
Discussion:
Findings from this trial will provide new insight into the early diagnosis and proper use of antibiotics based on repeated diagnoses in patients with diabetic foot osteomyelitis.
Trial registration:
This protocol was registered at Chinese Clinical Trial Registry (identifier: ChiCTR-DCC-15006104) on 12 March 2015.
Ethics:
Written approval for this trial was obtained from the Ethics Committee of the Tianjin Metabolic Diseases Hospital, Tianjin Medical University of China (approval No. DXBXYhMEC2015-7). This study will be performed in accordance with the guidelines of the
Declaration of Helsinki
, formulated by the World Medical Association.
Informed consent:
Written informed consent will be obtained from each participant.
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Polymerase chain reaction for diagnosis of isolated tuberculosis of the wrist joint
Jyoti Prakash, Kumar Neeraj, Kumar Dhirendra
April-June 2016, 1(2):88-89
DOI
:10.4103/2468-5674.183009
A 43-year-old female patient complained of pain, morning stiffness and mild swelling in the right wrist joint for 6 months. She had no history of any constitutional symptom, weight loss or involvement of other joints, but had suffered from pulmonary tuberculosis for 10 years and had completed a full course of directly-observed treatment short course. Nonresponsive management of inflammatory arthritis dragged us to use a highly sensitive test for tuberculosis, that is, polymerase chain reaction (PCR), and PCR findings from this patient were positive. This experience led us to conclude that even though conventional stain for acid fast bacilli comes to be negative, a more sensitive and specific test is needed for better diagnosis at earlier stages of the disease. However, PCR availability and cost is an issue of concern. Also a successful complete course of anti-tubercular therapy never gives the guarantee that there is no recurrence and no possibility of extra pulmonary tuberculosis, though the incidence of osteoarticular tuberculosis is relatively low.
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