You are on page 1of 6

J Oral Maxillofac Surg

59:539-544, 2001

Mandibular Distraction Force: Laboratory
Data and Clinical Correlation
Randolph C. Robinson, MD, DDS,* Patrick J. O’Neal, BS,†
and Ginger H. Robinson, BSN, RN‡
Purpose:

In vitro data were collected to measure torque-force values of an internal distraction device.
The measurements were correlated with in vivo torque readings in an attempt to better understand the
force required to distract the osteogenic bone callus of the human mandible during distraction osteogenesis.
Methods and Materials: Five internal craniofacial distraction devices were mounted on an apparatus
to test load limits and torque measurements. The apparatus aligned the devices so that weight provided
a force opposite and parallel to the vector of distraction. Weights were added in 5-lb increments, and the
devices were activated 0.5 mm for each torque reading. Torque readings were obtained from a calibrated
torque wrench. Measurements were plotted on a graph and correlated with clinical torque readings
obtained from 8 patients undergoing mandibular lengthening.
Results: The average torque for distracting the human mandible 0.5 mm twice a day was 4.2 ⫾ 1.6
Newton-centimeters (N-cm). The average slope of the in vitro data shows that 4.2 N-cm of torque is
equivalent to a force of 35.6 N. The average force of device failure was 235.8 N.
Conclusion: Torque-force diagrams offer an effective means for calibrating safety margins and load
capabilities for internal distraction devices. Quantification of axial forces encountered in mandibular
lengthening will help contribute to the overall understanding and biomechanics of mandibular distraction osteogenesis.
© 2001 American Association of Oral and Maxillofacial Surgeons
change in velocity of an object. The unit of force in
the metric system is the Newton (N). A Newton is that
force which, when applied to a 1 kg mass, gives it an
acceleration of 1 m/s/s. Therefore:
1 N ⫽ 1 kg ⫻ 1 m/s2 ⫽ 1 kg 䡠 m/s2
1 lb ⫽ 4.45 N
Torque is the force needed to cause a rotational
movement and is measured in Newton-meters or
Newton-centimeters (N-cm). Because most distraction devices use a threaded drive shaft to move the
ends apart, clinical measurements of torque are the
easiest to make. However, although torque is reflective of the load on the device, it is not a direct
measure of the distraction force at the osteotomy site.
Torque is a factor of the coefficient of friction of the
materials, the diameter of the drive shaft, and the
pitch angle of the threads in the gears, the surrounding soft tissue, and the bone callus. Therefore, torque
measurements are specific to a particular device, and
so it is necessary to establish the relationship between
the torque and the load for each device design. This
relationship is the slope of the line when a load is
plotted on the x axis and torque is plotted on the y
axis. This linear correlation can be used to indirectly
measure the force of distraction at the bone level for
a given torque observed during activation. This information can then be used in the clinical setting to

Distraction osteogenesis is becoming more common for reconstruction of facial bone deficiencies.
However, it is difficult to quantify the forces necessary to distract the active reparative bone callus
in the human during this process. Therefore, a
study of an internal distraction device is needed to
determine the torque-force values for the facial
bones, failure load limit requirements, and correlation of these in vitro measurements with those
found in clinical cases.
Force is the mass times the acceleration (F ⫽ ma).
In other words, force is the influence to cause a
*Chief of Oral and Maxillofacial Surgery, Saint Joseph Hospital,
Denver, CO.
†Director of Research and Development, Inter-Os Technologies,
Inc, Lone Tree, CO.
‡Nursing Researcher, 3110 Enterprises, Centennial, CO.
Dr Robinson is President of Inter-Os Technologies, Inc and Mr
O’Neal is Director of Research and Development at Inter-Os Technologies, Inc, Lone Tree, CO.
Address correspondence and reprint requests to Mr O’Neal:
7430 E Park Meadows Dr, Suite 300, Lone Tree, CO 80124; e-mail:
patrick.oneal@interos.com
© 2001 American Association of Oral and Maxillofacial Surgeons

0278-2391/01/5905-0010$35.00/0
doi:10.1053/joms.2001.22688

539

The device was lubricated with 1 to 2 drops of mineral oil in a similar manner as in the clinical setting and was opened and closed 2 to 3 times to ensure lubrication of the internal gears. which weighed 3 lbs. . Axial loading apparatus. Seebonk. determine the safety margins for device manufacturing and to give immediate clinical feedback regarding what may be happening in the distraction site (eg. Suspension wires from a horizontal steel bar were attached to the movable part of the device so that a vertical load could hang below the device (Fig 3). or incomplete osteotomies). MA) used a spring scale ranging from 0 to 24 inch-ounces. Device closed down with activation pin attached (top). Even though distraction osteogenesis of the mandible is well reported in the literature. It can also indicate if additional radiographs should be taken. Lone Tree. The FIGURE 3. A level was used to confirm the position. or if the device should be replaced. CO) and to correlate the data to clinical cases of mandibular distraction with the same device (Figs 1. Each plate may be removed or manipulated to accommodate bone contour and different vectors of device placement. FIGURE 1. Devices were loaded in 5-lb increments and tested until failure. or distance of distraction should be modified. The purpose of this article is to report laboratory data on the torque-force measurements of an internal craniofacial distractor. Mounted on the end of the torque Methods and Materials IN VITRO STUDY Five Bone Generators (Inter-Os Technologies Inc. 2).1-17 no study has been published describing the force necessary to distract the human mandible. This information can then be used to determine if the rate. Each fixation plate has 3 holes for screw fixation. vertical load provided a force opposite and parallel to the vector of distraction. device failure.540 MANDIBULAR DISTRACTION FORCE FIGURE 2. Bone Generator internal craniofacial distraction device. Device opened with activation pin removed (bottom). The torque wrench (Seebonk Inc. premature consolidation. rhythm. Lone Tree. CO) were mounted on a custom-designed vice and apparatus to hold them in a vertical orientation. The first torque measurements of each device were made with the suspension wire apparatus only. if an exploration should be made. the Bone Generator (Inter-Os Technologies Inc. The distraction device fixed on the mandible. The study also measured device load limits to failure and related the results to an overall margin of safety for internal distraction.

IN VITRO DATA All devices tolerated the torque measurements up to 28 lbs. After the measurements were made to 28 lbs. except for one. O’NEAL.5 mm of distraction. and an average slope was established.18 11. AND ROBINSON lateral and bilateral lengthening of the mandible. This process was carried out by activating the device for 1 full millimeter or 4 full turns using the activation wrench. or 0.30 13.54 16.2 ⫾ Table 1.14 4.or 10-lb increments until failure. with a mean lengthening distance of 11. and hemifacial microsomia (n ⫽ 1). The average load at failure.54 1. Distraction commenced 6 days postoperatively at a rate of 0. The study involved 8 patients (1 male.06 8. The device was closed back down to its original position after the load was removed.5 mm of distraction while the torque is measured.2 mm.14 4.22 2.3 lbs (SD).10 6. oral-facial-digital syndrome (n ⫽ 1).13 16.72 1.50 9. The measurements were converted from inch-ounces to Newton-centimeters and recorded on a spreadsheet on a laptop computer (Table 1). which was over 24 inch-ounces. Results wrench was an activation wrench used to activate the device in the clinical setting.48 15. mandibular hypoplasia with condylar agenesis (n ⫽ 2). The device was turned 2 full revolutions.24 5. each device was progressively loaded in 5.89 12. whose ages ranged from 6 to 20 years of age at the time of distraction.95 8. was 56.5 mm twice a day was 4. The devices all failed at load limits of 48 lbs or above. The average torque for distracting the human mandible 0.23 1. Patient undergoing 0.8 lbs ⫾ 6.42 1.65 8.48 12.65 9. the weight was removed and the device was closed back to its original position. IN VIVO STUDY IN VIVO DATA The correlative torque data taken from the clinical trials involved patients who underwent mandibular distraction osteogenesis using the Bone Generator.30 14. and one device sustained 63 lbs. The endpoint for torque measurements for the tests was determined by the limits of the torque wrench. A graph was then created using the graphing portion of the spreadsheet program (Fig 5).14 4.95 1. Measurements up to 28 inch-ounces could be made by reasonable continuation of the scale on the torque wrench.72 15.97 *Weight increased in 5-lb increments starting with the weight of the apparatus. Failure occurred at an average load of 53 ⫾ 10 lbs. Loading and torque measurements proceeded in 5-lb increments up to 28 lbs (including the 3 lb suspension apparatus). WEIGHT AND TORQUE MEASUREMENTS FOR DEVICES 1 TO 5 Torque Measurements (N-cm) Devices 1-5 Trial No. After each test.24 7.14 4. which was 3 lbs. The clinical indications for distraction osteogenesis were bilateral mandibular hypoplasia (n ⫽ 4).541 ROBINSON. 7 females). a torque/force line was drawn for each of the 5 devices.14 4.48 9.5 mm twice a day until the desired length was achieved.83 5.77 1.95 1. and the average observed torque measurement was made and recorded.68 8.14 2.26 1. Total distraction distances ranged from 4 to 17 mm. Two of the devices sustained 58 lbs. Care was given to maintain the vertical orientation because of the lateral load limits.48 11. Fourteen distraction devices were used for both uni- Torque measurements from the clinical trials are shown in Table 2.24 5. FIGURE 4.12 0 0. . Torque measurements were taken with the same torque wrench that was used in the in vitro laboratory setting (Fig 4). Weight (lbs)* 1 2 3 4 5 Average Torque SD 1 2 3 4 5 6 3 8 13 18 23 28 1.18 12.72 15. excluding the device that failed because of a loading error. This device failed at 38 lbs because of a lateral shift that occurred during loading of additional weight. The measurements were then plotted.

24 5. Measurement No.24 xx 7 14. This increase approaches 8.83 xx xx Right Left Right Left POD xx 12 Right Left POD Right Left POD Right Left 2.20 which found that in the sheep tibia 75% of the necessary distraction force was a result of the callus itself and only 25% to the surrounding tissue.48* * Torque increased with each successive turn. it is necessary to increase the distraction distance at each activation.24 4.75 mm of lengthening (Table 2).24 N-cm (Table 2). 1 (N-cm) Measurement No.06 7. It was discovered 7 days postoperatively that the device on the right side had jammed secondary to an incomplete osteotomy.83 2.5 mm twice per day is approximately 35. The heavy line shows the average of the 5 tested devices. 1.2. The current emphasis calls for greater miniaturization of the internal device.48* 8.2. postoperative day.65 9. It is important to note that the data obtained from the in vitro portion of this study measures only one of FIGURE 5.06 14 4. The slope and average torque values can be used to determine the axial force encountered at the bone level when various torque measurements are made during activation. Discussion The torque force diagram shows that for the Bone Generator.08 4. 7.5 mm. Abbreviations: POD.24 2. rhythm. XX. Torque was measured in Newton-centimeters as a function of force in pounds.13.9. unilateral case or no data obtained.89 1.65 xx 2. The first 3 measurements for both the left and right distraction devices in case number 3 were not used in calculating the average because of skewed data.542 MANDIBULAR DISTRACTION FORCE torque value for distraction is 4.48 N-cm for 0.65 5.6 N-cm.48 N-cm N-cm . Brunner et al18 reported that the percentage of muscle and soft tissue in the long bone that contributes to the total force measured is believed to be very low.06 6 9.83.83 7.5 mm during a regular rate and rhythm of 0. They also commented on studies by Aronson19 and Hollis. and the torque values then returned to expected levels. Graph of torque versus force for the Bone Generator in the in vitro portion of study.17 There is no standard regarding how much of a safety factor should be engineered into the design. The patient was returned to the operating room to complete the osteotomy.83 2. It is conceivable that the force to distract is proportional to the cross-sectional area of the callus.13 2.89 1. Right Left 1st 2. It would seem that this margin is adequate to accommodate most clinical problems.83 21 4. The average force of 35. The measurements of the forces at failure demonstrate that the Bone Generator is capable of withstanding 6 times the required force to distract 0. TORQUE MEASUREMENTS FROM CLINICAL TRIALS Measurement No.83 14 13 1.15.41 9 2. greater miniaturization is possible as long as a safety factor is incorporated into the design.837. which would place a requirement of 15 lbs on the device.2.65 16 2. However.5.83 2.83. torque-force measurements will help establish such standards without compromising device integrity or safety.6 N.83 2nd 4.24 4.83 5.835.24 3rd 8.6 N needed to distract the mandible means that in designing a device.83.24 4.2. Building in a greater margin requires larger designs and possibly greater manufacturing costs and is probably not necessary. 3 (N-cm) 4 (N-cm) 5 (N-cm) 6 (N-cm) Case POD POD POD 1 15 2 20 3 4 5 6 7 8 Right Left 17 5 9 14 6 2. 2 (N-cm) Measurement No.41 2.06 N-cm of torque is equal to a force of 13 lbs.48 8.838. Measurement No. At times. and age of the patient. Measurement No.41 2. This torque value means that the force necessary to move a distraction callus 0. modified by the rate.65 Number of Turns* 11 2.835. The in vivo data also show that the average Table 2.

thus enabling rapid distraction.20 will aim to establish the percentage of force for the craniofacial model that is contributed by the callus versus the surrounding muscle and connective tissue. Clinical experience has demonstrated that torque-force values that fall within this range appear to be an acceptable measurement during uneventful lengthening of the human mandible. Case number 3 in the clinical trial demonstrated 2 of the above situations (Table 2). Ann Plast Surg 24:231. which only registered 1.0 N-cm. etiology. However.89. However. Karp NS.29 Future studies. and 14.31 This is of particular concern for internal devices.22. 1995 5. and this has helped to advance the field of long bone distraction osteogenesis. 1990 2. leading to radiologic examination and early detection. These values were higher than expected and considerably higher in comparison with the left side. Plast Reconstr Surg 103:1592. Maull DJ: Review of devices for distraction osteogenesis of the craniofacial complex. Barber JE. other complications are inherent with this technique. Measuring the force required to distract the human mandible is difficult and is not currently reported in the literature. which currently lack the ability for bidirectional control. Premature consolidation may also be anticipated and possibly avoided. Even when multiplanar devices are used. such as forces from the suprahyoid muscles that are frequently encountered during mandibular lengthening. and seventh day.26. No significant difference was noted between torque readings with the varying vectors. device failure may be anticipated with excessive or minimal torque measurements. Rutrick RE. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 86:648.6.543 ROBINSON. References 1. Chin and Toth15 used torque measurements on patients who underwent a Le Fort III advancement to test and monitor the limits of fracture.19 and Hollis et al.32 Nonaxial forces will vary with different vectors of elongation. et al: Lengthening the human mandible by gradual distraction. Torque-force measurements from the clinical portion of this study dealt primarily with vectors that were parallel and oblique to the mandibular rami.41 N-cm. For example.33 The protocol for the current study maintained the standard rate and rhythm of 0. McCarthy JG.25. McCarthy JG: Bone lengthening in the craniofacial skeleton. the in vitro testing neglects to account for lateral forces. with a latency period of 6 days. Chin and Toth used a protocol that deviated from the standard by not observing a latency period and by performing 10 mm of distraction intraoperatively followed by an additional 10 mm of distraction within 2 to 3 days following surgery. This patient maintained torque values on the right side of the mandible of 9.23 device orientation. The ability to anticipate and quantify the force encountered in mandibular distraction enhances the development and design of devices. 1999 6.34-38 Implications for future studies involving the force of mandibular distraction will not only contribute to a better understanding of mandibular distraction. Burstein FD: Distraction osteogenesis of the human craniofacial skeleton: Initial experience with new distraction system. 1992 4.26 Recent studies have demonstrated ways to prevent and augment a faulty distraction vector. but will also offer the surgeon a valuable tool for monitoring the progression of the distraction phase. Semin Orthod 5:64. Karp N.25 and the vector of distraction. In addition. Cohen SR. similar to the previously mentioned studies by Brunner et al. However. J Craniofac Surg 6:368.5 to 7. Torque-force measurements will contribute to manufacturing standards and will help to establish an adequate margin of safety.5 mm twice a day. changing the vector of the distal segment may induce a change in the position of the proximal segment. Plast Reconstr Surg 89:1. an incomplete osteotomy may be detected and resolved at an earlier stage. Calibrating craniofacial distraction devices with torque-force measurements will also allow the surgeon to monitor and exercise more control over the distraction phase. The progressive nature of the torque values for this case prompted radiologic review and surgical exploration.13 N-cm on the fifth. Torque measurements are invaluable for monitoring the distraction phase from a perspective of safety and control.18 Aronson. sixth. postoperatively. Thorne CH.21 device rigidity.22.89. 9.30. The force of distraction has been measured in long bones. AND ROBINSON the variables related to the force encountered in mandibular lengthening. O’NEAL. This rate and rhythm have permitted the establishment of an average torque that falls within a range of 1. Cohen SR: Craniofacial distraction with a modular internal distraction system: Evolution of design and surgical techniques. The multidirectional device allows for a change in the distraction vector. Torque measurements of 14 to 18 N-cm were observed without fracture.13 The exact response and degree to which lateral counteractive forces affect the bone callus will vary with patient age. Surgical exploration confirmed an incomplete osteotomy causing the right distraction device to jam. The axial loads from the laboratory provide a great deal of information about the force required to distract the callus. 1999 3. respectively. Nuveen EJ. Haug RH. 1998 .24. Schrieber J. Device placement and the vector of distraction are of paramount importance when planning craniofacial distraction. the planned distraction vector may differ from the resultant vector because of forces encountered during and after elongation. et al: An in vitro evaluation of distractors used for osteogenesis.26-28 The effects of device orientation have yet to be established in the clinical setting and have thus far been uneventful.

2000 30. Tavakoli K. J Craniofac Surg 10: 202. 1998 37. Cope JB. 1998 18. Ann Plast Surg 42:470. 1995 13. Hammer B. A clinical study. Grayson BH: Distraction osteogenesis of the mandible: A ten-year experience. Diner PA. Thomason JJ. et al: In vivo distraction forces in extendible endoprosthetic replacements—a study of 34 patients. The International Society for Fracture Repair. Cope JB. Hanson PR. Plast Reconstr Surg 100:819. Mizrahhi RD. 1998 35. Schweiberer L. Contasti GI. Brunner UH. Chin M. 1999 32. Prein J: Manipulation of callus after linear distraction: A “lifeboat” or an alternative to multivectorial distraction osteogenesis of the mandible? Plast Reconstr Surg 105:674. Grayson B: Force level and strain patterns during bilateral mandibular osteodistraction (discussion). Samchukov ML. et al: Mechanical Induction of osteogenesis: The importance of pin rigidity. Hollis JM. Ahn JG. Semin Orthod 5:3. Mehrara BJ. McCormick SU. et al: Controlled multiplanar distraction of the mandible: Device development and clinical application. Kunz C. Polley JW. Stewart KJ. Am J Orthod Dentofac Orthop 116:264. Bell WH. Martiinez H. Contasti GI. McCarthy JG. 1996 . Harrison B. Gardner TN. Sinn DP: Mandibular distraction osteogenesis with multidirectional extraoral distraction device in hemifacial microsomia patients. Cherkashin AM. 2000 25. 1994 38. Cordey J. Meswania JM. Kollar EM. Simpson H. Walker PS. Wolfson N. et al: Force and stiffness changes during Ilizarov leg lengthening. Poole MD: Distraction osteogenesis in craniofacial surgery: A review. 1999 31. Med Eng Phys 20:708. Toth BA: Distraction osteogenesis in maxillofacial surgery using internal devices: Review of five cases. Rowe NM. J Oral Maxillofac Surg 57:1214. Stelnicki EJ. Semin Orthod 5:25. Williams KJ. 1988 23. 1998 34. Cherkashin AM: The effect of sagittal orientation of the distractor on the biomechanics of mandibular lengthening. McCormick MS. 1989 36. Martiinez H. Guerrero CA. Aronson J. April 1992 20. Toth BA: Le Fort III advancement with gradual distraction using internal devices. J Craniofac Surg 24:92. 1997 8. Samchukov ML. Figueroa AA. 1999 24. 1992 21. 1999 10.544 7. Br J Oral Maxillofac Surg 35:383. Figueroa AA: Commentary on midface advancement by bone distraction on the treatment of cleft deformities and on distraction osteogenesis and its application to the midface and bony orbit in the craniosynostosis syndrome. Aronson J: Experimental and clinical experience with distraction osteogenesis. Diner PA. et al: Vector of device placement and trajectory of mandibular distraction. 1999 28. Hearn TC. 1997 12. et al: Force level and strain patterns during bilateral mandibular osteodistraction. Yamashita J. J Oral Maxillofac Surg 54:45. J Bone Joint Surg Br 78:979. 1999 22. et al: Submerged intraoral device for mandibular lengthening. et al: Biomechanics of mandibular distractor orientation: An animal model analysis. Santiago PE. 1998 17. 1999 27. prediction tracings. Grayson BH. Clin Orthop Rel Res 301:147. Wood RJ. et al: Intraoral distraction for mandibular lengthening: A technical innovation. J Craniomaxillofac Surg 25:116. et al: Distraction osteogenesis of the mandible using a submerged intraoral device: A report of three cases. 1999 9. J Craniofac Surg 9:119. Kenwright J: The forces which develop in the tissue during leg lengthening. and case outcomes. Guerrero CA. 1999 26. Chin M. 2000 33. Semin Orthod 5:35. Aronson J: Mechanical factors generated during distraction osteogenesis. Melugin MB: Orthodontic management of the patient undergoing mandibular distraction osteogenesis. Cunningham JL. Tharanon W. Aldegheri R: Distraction osteogenesis for the lengthening of the tibia in patients who have limb-length discrepancy or short stature. Boyd CM. 1994 19. Cleft Palate Craniofac J 31:473. Plast Reconstr Surg 96: 978. Kollar EM. McCarthy JG. 1996 15. 1996 11. J Pediatr Orthop 8:396. 1997 29. Grayson BH. J Oral Maxillofac Surg 58:178. Aronson J. Three-dimensional treatment planning. et al: Force-displacement behaviour of biological tissue during distraction osteogenesis. et al: Mandibular widening by intraoral distraction osteogenesis. Ottrot. et al: Force required for bone segment transport in the treatment of large bone defects using medullary nail fixation. Luchs JS. Cope JB. Bell WH. Healy S. Clin Orthop Rel Res 250:58. J Oral Maxillofac Surg 58:171. et al: Introduction of an intraoral bone-lengthening device. J Bone Joint Surg 81:624. Fox RM. et al: Angiogenesis during mandibular distraction osteogenesis. France. Trans Orthop Res Soc 38:14. J Oral Maxillofac Surg 57:192. Sneath RS. Simpson AHRW. et al: Biomechanical considerations in distraction of the osteotomized dentomaxillary complex. Hofmann OE: Differential loads in tissues during limb lengthening. Evans M. 1999 14. J Craniofac Surg 8:473. J Craniofac Surg 9:322. J Oral Maxillofac Surg 57:952. Ann Plast Surg 40:88. Braun S. Staffenberg DA. et al: Intraoral mandibular distraction osteogenesis. Proc Inst Mech Eng 212:151. McCarthy JG. 1997 16.