Does osteoporosis increase complication risk in surgical fracture treatment? A protocol combining new endpoints for two prospective multicentre open cohort studies

Sabine Goldhahn, Franz Kralinger, Daniel Rikli, Marta Marent, Jörg Goldhahn, Sabine Goldhahn, Franz Kralinger, Daniel Rikli, Marta Marent, Jörg Goldhahn

Abstract

Background: With an ever-increasing elderly population, orthopaedic surgeons are faced with treating a high number of fragility fractures. Biomechanical tests have demonstrated the potential role of osteoporosis in the increased risk of fracture fixation complications, yet this has not been sufficiently proven in clinical practice. Based on this knowledge, two clinical studies were designed to investigate the influence of local bone quality on the occurrence of complications in elderly patients with distal radius and proximal humerus fractures treated by open reduction and internal fixation.

Methods/design: The studies were planned using a prospective multicentre open cohort design and included patients between 50 and 90 years of age. Distal radius and proximal humerus fractures were treated with locking compression 2.4 mm and proximal humerus internal locking plates, respectively. Follow-up examinations were planned for 6 weeks, 3 and 12 months as well as a telephone interview at 6 months. The primary outcome focuses on the occurrence of at least one local bone quality related complication. Local bone quality is determined by measuring bone mineral density and bone mineral content at the contralateral radius. Primary complications are categorised according to predefined factors directly related to the bone/fracture or the implant/surgical technique. Secondary outcomes include the documentation of soft tissue/wound or general/systemic complications, clinical assessment of range of motion, and patient-rated evaluations of upper limb function and quality of life using both objective and subjective measures.

Discussion: The prospective multicentre open cohort studies will determine the value of local bone quality as measured by bone mineral density and content, and compare the quality of local bone of patients who experience a complication (cases) following surgery with that of patients who do not (controls). These measurements are novel and objective alternatives to what is currently used.

Trial registration numbers: Clinical Trials.gov NCT01144208 and NCT01143675.

Figures

Figure 1
Figure 1
Flow chart of the study protocol.

References

    1. Raisz LG. Pathogenesis of osteoporosis: concepts, conflicts, and prospects. J Clin Invest. 2005;115:3318–3325. doi: 10.1172/JCI27071.
    1. Aaron JE, Makins NB, Sagreiya K. The microanatomy of trabecular bone loss in normal aging men and women. Clin Orthop Relat Res. 1987. pp. 260–271.
    1. Mittra E, Rubin C, Qin YX. Interrelationship of trabecular mechanical and microstructural properties in sheep trabecular bone. J Biomech. 2005;38:1229–1237. doi: 10.1016/j.jbiomech.2004.06.007.
    1. Johnell O, Kanis J. Epidemiology of osteoporotic fractures. Osteoporos Int. 2005;16:S3–S7. doi: 10.1007/s00198-004-1702-6.
    1. Sambrook P, Cooper C. Osteoporosis. Lancet. 2006;367:2010–2018. doi: 10.1016/S0140-6736(06)68891-0.
    1. Kanis JA, Johnell O, De Laet C, Johansson H, Oden A, Delmas P. et al.A meta-analysis of previous fracture and subsequent fracture risk. Bone. 2004;35:375–382. doi: 10.1016/j.bone.2004.03.024.
    1. Goldhahn J, Suhm N, Goldhahn S, Blauth M, Hanson B. Influence of osteoporosis on fracture fixation--a systematic literature review. Osteoporos Int. 2008;19:761–772. doi: 10.1007/s00198-007-0515-9.
    1. Seebeck J, Goldhahn J, Stadele H, Messmer P, Morlock MM, Schneider E. Effect of cortical thickness and cancellous bone density on the holding strength of internal fixator screws. J Orthop Res. 2004;22:1237–1242. doi: 10.1016/j.orthres.2004.04.001.
    1. Dayer R, Rizzoli R, Kaelin A, Ammann P. Low protein intake is associated with impaired titanium implant osseointegration. J Bone Miner Res. 2006;21:258–264. doi: 10.1359/JBMR.051009.
    1. Hollevoet N, Verdonk R. Outcome of distal radius fractures in relation to bone mineral density. Acta Orthop Belg. 2003;69:510–514.
    1. Barrios C, Brostrom LA, Stark A, Walheim G. Healing complications after internal fixation of trochanteric hip fractures: the prognostic value of osteoporosis. J Orthop Trauma. 1993;7:438–442. doi: 10.1097/00005131-199310000-00006.
    1. Eckstein F, Lochmuller EM, Lill CA, Kuhn V, Schneider E, Delling G. et al.Bone strength at clinically relevant sites displays substantial heterogeneity and is best predicted from site-specific bone densitometry. J Bone Miner Res. 2002;17:162–171. doi: 10.1359/jbmr.2002.17.1.162.
    1. Thiele OC, Eckhardt C, Linke B, Schneider E, Lill CA. Factors affecting the stability of screws in human cortical osteoporotic bone. J Bone Joint Surg Br. 2007;89-B:701–705. doi: 10.1302/0301-620X.89B5.18504.
    1. Goldhahn S, Sawaguchi T, Audigé L, Mundi R, Hanson B, Bhandari M. et al.Complication reporting in orthopaedic trials. A systematic review of randomized controlled trials. J Bone Joint Surg Am. 2009;91:1847–1853. doi: 10.2106/JBJS.H.01455.
    1. Neer CS. Displaced proximal humeral fractures. I. Classification and evaluation. J Bone Joint Surg Am. 1970;52-A:1077–1089.
    1. Henry MH, Griggs SM, Levaro F, Clifton J, Masson MV. Volar approach to dorsal displaced fractures of the distal radius. Tech Hand Up Extrem Surg. 2001;5:31–41. doi: 10.1097/00130911-200103000-00005.
    1. Philos + Philos Long: 2.4 mm LCP Distal Radius Plates: Technique Guide. Synthes (USA) 2004.
    1. Philos + Philos Long: The anatomic fixation system for the proximal humerus with angular stability. Surgical technique: Technique Guide. Synthes (Switzerland) 2005.
    1. Audigé L, Goldhahn S, Daigl Cattaneo M, Goldhahn J, Blauth M, Hanson B. How to document and report orthopedic complications in clinical studies. A proposal for standardization. Arch Orthop Trauma Surg. in press .
    1. Osteoporosis prevention, diagnosis, and therapy. NIH Consens Statement. 2000;17:1–45.
    1. Link TM, Majumdar S. Osteoporosis imaging. Radiol Clin North Am. 2003;41:813–839. doi: 10.1016/S0033-8389(03)00059-9.
    1. Prevention and management of osteoporosis. World Health Organ Tech Rep Ser. 2003;921:1–164.
    1. Sievanen H, Kannus P, Oja P, Vuori I. Precision of dual energy x-ray absorptiometry in the upper extremities. Bone Miner. 1993;20:235–243. doi: 10.1016/S0169-6009(08)80004-9.
    1. Diederichs G, Korner J, Goldhahn J, Linke B. Assessment of bone quality in the proximal humerus by measurement of the contralateral site: a cadaveric analyze. Arch Orthop Trauma Surg. 2006;126:93–100. doi: 10.1007/s00402-006-0103-z.
    1. Ryf C, Weymann A. Range of Motion - AO Neutral-0 Method. Measurement and Documentation. New York: Thieme; 1999.
    1. Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG) Am J Ind Med. 1996;29:602–608. doi: 10.1002/(SICI)1097-0274(199606)29:6<602::AID-AJIM4>;2-L.
    1. EuroQol--a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy. 1990;16:199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. Mathiowetz V, Weber K, Volland G, Kashman N. Reliability and validity of grip and pinch strength evaluations. J Hand Surg Am. 1984;9:222–226.
    1. Lidstrom A. Fractures of the distal end of the radius. A clinical and statistical study of end results. Acta Orthop Scand Suppl. 1959;41:1–118.
    1. MacDermid JC. Development of a scale for patient rating of wrist pain and disability. J Hand Ther. 1996;9:178–183.
    1. Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine. 2000;25:3186–3191. doi: 10.1097/00007632-200012150-00014.
    1. Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987. pp. 160–164.
    1. Constant CR. Assessment of shoulder function. Orthopade. 1991;20:289–294.
    1. Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a shoulder pain and disability index. Arthritis Care Res. 1991;4:143–149. doi: 10.1002/art.1790040403.
    1. Beaton D, Richards RR. Assessing the reliability and responsiveness of 5 shoulder questionnaires. J Shoulder Elbow Surg. 1998;7:565–572. doi: 10.1016/S1058-2746(98)90002-7.
    1. Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993;46:1417–1432. doi: 10.1016/0895-4356(93)90142-N.
    1. Wambacher M, Oberladstätter J, Rieger M. In: Schulterchirurgie. 4. Habermeyer P, Lichtenberg S, Magosch P, editor. Munich: Urban and Fischer; 2010. Konventionelle Radiologie und Computertomographie der Schulter; pp. 114–115.
    1. Hollevoet N, Verdonk R. Outcome of Distal Radius Fractures in Relation to Bone Mineral Density. Acta Orthop Belg. 2003;69:510–514.
    1. Dias JJ, Wray CC, Jones JM. Osteoporosis and Colles' fractures in the elderly. J Hand Surg Br. 1987;12:57–59. doi: 10.1016/0266-7681(87)90058-1.
    1. Hollevoet N, Goemaere S, Mortier F, Van Bouchaute P, Kaufman JM, Verdonk R. The role of osteoporosis in distal radius fractures. Acta Orthop Belg. 2000;66:163–168.
    1. Brunner F, Sommer C, Bahrs C, Heuwinkel R, Hafner C, Rillmann P. et al.Open reduction and internal fixation of proximal humerus fractures using a proximal humeral locked plate: a prospective multicenter analysis. J Orthop Trauma. 2009;23:163–172. doi: 10.1097/BOT.0b013e3181920e5b.
    1. Südkamp N, Bayer J, Hepp P, Voigt C, Oestern H, Kääb M. et al.Open reduction and internal fixation of proximal humeral fractures with use of the locking proximal humerus plate. Results of a prospective, multicenter, observational study. J Bone Joint Surg Am. 2009;91:1320–1328. doi: 10.2106/JBJS.H.00006.

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