RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA
ANNEXURE - II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS. / DR. VEERESH PATAGE,
#82, VIVEK HOSTEL,
KIMS, VIDYANAGAR,
HUBLI – 580022
2. / NAME OF THE INSTITUTION. / KARNATAKA INSTITUTE OF MEDICAL SCIENCES, HUBLI
3. / COURSE OF STUDY AND SUBJECT / M.S. ORTHOPAEDICS
4. / DATE OF ADMISSION / 21st JUNE 2012
5. / TITLE OF THE TOPIC / “MANAGEMENT OF DIAPHYSEAL FRACTURES OF BOTH BONES OF FOREARM BY INTERNAL FIXATION USING LOCKING COMPRESSION PLATE AND SCREWS”
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8. / BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR THE STUDY
Forearm bone fractures are commonly encountered in adults today’s modern industrial era. While closed methods of reduction and immobilization by conservative methods may be successful in diaphyseal fractures of radius and ulna in children1, same is not true in case of diaphyseal fractures of radius and ulna in adults. Fractures of the forearm bones may result in severe loss of function unless adequately treated. Severe loss of function may result even though adequate healing of the fractures occurs. Diaphyseal fractures of the radius and ulna present specific problems in addition to the problems common to all fractures of the shafts of long bones. In addition to regaining length, apposition, and axial alignment, achieving normal rotational alignment is necessary if a good range of pronation and supination is to be restored. Mal-union and nonunion occur more frequently because of the difficulty in reducing and maintaining the reduction of two parallel bones in the presence of the pronating and supinating muscles that have angulating and rotational influences2. Because of these factors open reduction and internal fixation with plating is generally accepted as the best method of treatment for displaced diaphyseal fractures of the forearm in the adult. 3Hitherto most commonly used implant for fixation of diaphyseal fractures of ulna and radius has been dynamic compression plate and nonself tapping cortical screws, which is based on principle of interfragmentary compression.The use of bone-implant constructs through interfragmentary compression may result in devascularisation of bone fragments and delayed fracture healing.
In conventional plating, the actual stability results from the friction between the plate and the bone, which in turn may prevent periosteal perfusion4,5. The biologic plating entails a sufficiently stable fixation of the bone fragments, allowing early mobilization without major disturbance of the vascularization6. The limited contact dynamic compression plates (LC-DCP), developed in 1991, was said to reduce the bone-plate contact by approximately 50% to minimize the disruption of periosteal blood vessels beneath the plate. But the LC-DCP still relied on the plate-bone interface for stability and the problem of confluent contact areas was not completely resolved.
Later on, the Point Contact Fixator (PC-Fix), which did not have surface contact with the bone but only point contacts, was developed4. In the point contact fixator (PC-Fix) the unicortical locking head screws can be locked into the screw hole on the plate. No compression of the plate on the bone is required.
Leung et al. in a prospective, randomized trial comparing the LC-DCP with the PC-Fix in the treatment of forearm fractures concluded that the two implants appeared to be equally effective for the treatment of diaphyseal forearm fractures.4 Comparison of the two groups revealed no demonstrable differences in terms of fracture healing, pain, functional results, refracture and infection rates.
Locking compression plate (LCP) was devised by combining the features of a LC-DCP and a PC-Fix.4 Each of the screw holes allows insertion of a conventional screw or a locking head screw, as it has features of both a smooth sliding compression hole and a threaded locking hole. Theoretically, this allows for more rapid bone healing besides decreasing infection, bone resorption, delayed union/non-union and secondary loss of reduction.5 But reports on the results of clinical application of LCP are few, especially on its efficacy, or superiority over other plates in the treatment of diaphyseal fractures of forearm bones.3,8,9,10
Although LCPs have theoretical advantages, there is need for evaluating their efficacy through well-planned trials and accurate documentation. We aim to evaluate the use of LCPs in diaphyseal forearm fractures, as plate fixation remains the most-accepted fixation method.
6.2 REVIEW OF LITERATURE
·  In the year 1852 MATHYSEN introduced plaster of Paris but it was not used in treatment of fractures of forearm bones. Plaster of Paris was popularized by Bohler (1929).
·  Carrel (1938) studied the causes of poor results of management of forearm fractures by splinting and pointed out to the reasons as inadequate immobilization, imperfect reduction and early removal of splints. He claimed that proper traction gave satisfactory results.
·  Cowe (1956) studied 54 cases of fracture forearm bones and concluded that open reduction and plating give excellent results except when severe injury or comminuted fracture or both occurred.
·  In the same year Egger stressed the importance of controlling torque stress and restoration of bony continuity in management of forearm bone fractures. Egger achieved fixation of radius and ulna fractures by medullary fixation in radius and narrow slotted plate in ulna with bone grafts wherever necessary.
·  Anderson LD et al, at the Campbell Clinic and City of Memphis Hospital from 1960 to 1970, also analyzed that out of 244 patients (216 with closed and twenty-eight with open fractures) had 330 acute diaphyseal fractures of the radius and ulna which were treated with ASIF compression plates and followed for from four months to nine years. One hundred and twelve patients had fractures of both bones of the forearm. The over-all rate of union for the radius was 97.9 percent and for the ulna 96.3 per cent. ASIF compression plates, therefore, provided a successful method for obtaining union and restoring optimum function after acute diaphyseal fractures of the forearm.11
·  In 1972 Dodge. S., and Cady, G W. treated fractures of the radius and ulna with compression plates in a retrospective study and analyzed 119 compression plates used in 78 patients with forearm fractures and concluded that the basic objectives of internal fixation namely i)Anatomical reduction ii)Preservation of vascularity iii)Mechanical stable fixation and iv) Rapid mobilization of joints in proximity was best achieved by compression plates.12
·  In 1980 G.GRACE et al of medical corps United States Army have published a paper on treatment of both bone forearm fractures by rigid fixation with early motion. They discussed 64 adults patients with 92 acute diaphyseal fractures of the forearm treated with plate and screw fixation, they analyzed the early post operative motion. Patients with open fractures and those with both bone forearm fractures lost significantly more rotation of forearm irrespective of treatment compared with other groups of patients in the series. A programme of early active motion without immobilization increased range of motion of forearm fractures, however this was not in case of single bone( radius or ulna)fractures 13
·  Hadden WA, Reschauer R, Seggl W. reported a series of 111 forearm fractures in 108 individuals involving 177 individual bones, and treated by AO plating . There were 18 different surgeons. Open fractures occurred in 24 per cent of limbs. Reviews at a mean of 3 years after the accident showed 97 per cent of bones to be solidly united and satisfactory function to be achieved in 80 per cent of limbs. Deep infection occurred 6 times, and non-union in 7 bones. Cross-union developed in 6 patients, all of whom had sustained head injuries. Seven patients sustained operative nerve injuries. It was felt that the implant of choice at the moment is the small fragment Dynamic Compression Plate (DCP).14
·  Chapman MW Gordon GE Zissimoss AG in 1989 reported a retrospective study of eighty-seven patients who had 129 diaphyseal fractures of either the radius or the ulna, or both, and who were treated with fixation using an AO dynamic-compression plate. Open fractures were internally fixed primarily, and both comminuted and open fractures routinely had bone-grafting. Ninety-eight per cent of the fractures united, and 92 per cent of the patients achieved an excellent or satisfactory functional result. The rate of infection was 2.3 per cent. Refracture occurred after removal of a 4.5-millimetre dynamic-compression plate in two patients, but there were no refractures after removal of a 3.5-millimetre plate. The 3.5-millimetre plate system gave excellent results in patients who had a fracture of the forearm, and it minimized the risk of refracture. Our results demonstrated that immediate plate fixation of an open fracture of the forearm, with a low rate of complications, is possible.15
·  Schemitsch EH, Richards RR studied 55 adults who had a fracture of both bones of the forearm managed with plating and were followed for a mean of 6years (range, one year to sixteen years and two months) with functional and radiographic assessment. Mal-union was quantified by measurement of the amount and location of the maximum radial bow in relation to the contra lateral, normal forearm. 54 of the radial and the ulna fractures united. 84%of the patients had an excellent, good, or acceptable functional result, according to the criteria of Grace and Eversmann. Bone-grafting did not affect the rate of union. Restoration of the normal radial bow was related to the functional outcome. A good functional result (more than 80 per cent of normal rotation of the forearm) was associated with restoration of the normal amount and location of the radial bow. Similarly, the recovery of grip strength was associated with restoration of radial bow towards normal16
·  Haas N, Hauke C, Schütz M, Kääb M, Perren SM in 2001 reported treatment of diaphyseal fractures of the forearm using the Point Contact Fixator (PC-Fix): results of 387 fractures of a prospective multicentric study (PC-Fix II); in which fractures of the forearm are considered to be a very good indication for plating. Conventional plating is still technically demanding. Extensive animal studies show that there is potential for improvement. The method consists of using an internal fixator that minimizes implant contact to the bone to reduce biological damage. Furthermore, foregoing the need for precise reduction and inter fragmental compression makes it easier to use and, therefore, it should be safer. The goal of the study was to observe handling qualities, healing, and complications. For this purpose the study was designed to yield a very high follow-up in clinics with adequate experience and with a number of different surgeons performing the internal fixation. The study was designed as a prospective multicentre investigation in 16 trauma centres worldwide. To test the new approach to internal fixation, diaphyseal fractures of the forearm were stabilized surgically with the PC-Fix (Point-Contact Fixator) system, namely, 387 fractured bones involving 277 forearms in 272 patients. Internal fixation was performed using 387 PC-Fixators. 21% of the fractures were open and 25% occurred in poly-traumatized patients. The rate of follow-up was 97%. 355 fractured bones healed uneventfully within four months. Overall, there were 32 complications before bone union occurred; 27 of these bones required re-operation (27 of 387, 7%). All of them subsequently healed without further complications. There were 15 delayed or non-unions and seven implant loosenings, two of which were associated with infection. Two superficial (0.6%) and two deep infections (0.6%) occurred in 306 closed fractures. Deep infection developed in one of 81 osteosynthesis of open fractures (1.2%). Other complications included one synostosis, fractures with the implant in situ with adequate trauma involving three bones, and two secondary correction procedures for postoperative mal alignment. There were seven refractures occurring at a mean of three weeks after the removal of 150 PC-Fixators (4.7%). This study demonstrated that the technique of using an internal fixator is a simple one for the fixation of forearm fractures, resulting in shorter duration of surgery with a low rate of complications compared with the data reported in the literature on conventional techniques for forearm fracture stabilization.17
·  F LEUNG, SP CHOW (2006), studied 45 forearm fractures treated by open reduction and internal fixation with 3.5mm stainless steel LCPs. Radiographic assessment was performed at 3,6,12 and 18 months. Two patients had delayed union but none had nonunion. 33% of the fractures were reduced anatomically. 56% of the fractures healed with no or minimal callus formation and 44% with moderate callus formation. Mean healing time was 16 months. The LCP is an effective bridging device used for treating comminuted fractures. 18
·  SHARMA, H.DANG (2006), conducted a prospective study in 30 adult patients of forearm fractures. Follow up was done at 3, 6, and 12 months. Clinical assessment was done for functional outcome. All the fractures united with mean union time of 12.6 weeks. LCP is a stronger construct and by preventing primary and secondary loss of reduction it does not alter the natural course of healing of fracture, which is not possible with the use of DCP and LC-DCP.19
6.3 OBJECTIVES OF STUDY
1.  To evaluate the results of treatment of displaced fractures of both bones of forearm treated by internal fixation with “locking compression plate and screws”
2.  To note intraoperative and postoperative complications of management.
3.  To assess the efficacy and advantage of this treatment modality.
MATERIALS AND METHODS
7.1 SOURCE OF DATA
The proposed study is a hospital based prospective study centered in Karnataka Institute of Medical Sciences, Hubli during the period between November 2012 to October 2014.
7.2 METHOD OF COLLECTION OF DATA (including sampling procedures if any) :
INCLUSION CRITERIA
1. Age group adults (>18years)
2. Male and female patients. 3. Radiologically diagnosed closed fractures of both bones of forearm (Diaphyseal fractures of radius and ulna)
4. Consent to participate in the study.
EXCLUSION CRITERIA
1. Open fractures of both bones of forearm. 2. Fractures of both bones of forearm with compartment syndrome needing
fasciotomy.
3. Fractures of both bones of forearm needing vascular repair.
4. Fractures of both bones of forearm associated with distal radius/ulna. 5. Refusal to provide informed consent.
Period of follow-up
The follow up would be for one year with evaluation at 1 month, 3 months and 1 year.