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There is debate over the best management for acetabular (hip) fractures that occur within the geriatric population. Geriatric patients, 60 years or older, are at greater risk for operative complications because they tend to have poorer bone quality, complicated fractures, and multiple health problems. Physicians currently have no guidelines as to the best surgical management for these particular fractures, because there is little data on the long-term outcomes of these injuries. The use of internal fixation (a nail or plate) is a standard method for repairing these injuries, however when the injuries are complicated it is predicted to have a poorer outcome than performing internal fixation along with total hip arthroplasty (joint reconstruction). Given the significant problems that result from hip fractures in this population, our study is designed to determine the best method for treatment of acetabular fractures and to clarify the criteria for treatment with guidelines assisting the physician in selecting the appropriate treatment.
This is a pilot randomized controlled study conducted at Shock Trauma and University of Maryland Medical Center of patients 60 years and older who have sustained an acetabular fracture. Based on the patient's fracture pattern, dome impaction, posterior wall component and femoral head fracture, the patients will be randomized to their treatment arm. One treatment arm will consist of patients who are treated with ORIF alone. The other treatment will undergo ORIF as well as concomitant total hip arthroplasty in the same surgery.
Furthermore the functional status evaluation of each patient will be standardized using the WOMAC (Western Ontario McMaster Universities OA index), a lower extremity specific outcome score that has been validated for use in patients of similar age to our cohort study in osteoarthritis or after total hip arthroplasty; and the SF-36 (Short Form-36) which is a validated general health outcome measure that calculates mental and physical subcomponent scores. Patients will also be assessed using the Harris Hip Score, which has been used for patients with post-traumatic arthritis undergoing conversion to total hip arthroplasty.
All patients will be followed as standard of care for their follow up visits at 6 month and 1 year. As the patient population at Shock Trauma and University of Maryland Medical Center are all treated by the same orthopaedic group, one dedicated investigator will follow their outcomes. To minimize the risk of bias, I, the individual administering the WOMAC or SF-36 will be blinded to the patient's treatment arm. As the patient will be giving consent for their treatment, they cannot be blinded. Also, the surgeons (and the research coordinator) will know which group the patient is in, but the investigator collecting the data will not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RCT - ORIF | Active Comparator | A patient in this study arm consents to randomization and receives RCT - ORIF as his/her treatment assignment. He/she will have his/her acetabular fracture treated by open reduction internal fixation. |
|
| RCT - (THA) + ORIF | Active Comparator | A patient in this study arm consents to randomization and receives RCT - (THA) + ORIF as his/her treatment assignment. He/she will have his/her acetabular fracture treated by open reduction internal fixation with primary total hip arthroplasty. |
|
| OBS - ORIF | No Intervention | A patient in this study arm does not consent to randomization, but does agree to be involved in the observational study. He/she decides, with input from his/her surgeon, to have his/her acetabular fracture treated by open reduction internal fixation. | |
| OBS (THA) + ORIF | No Intervention | A patient in this study arm does not consent to randomization, but does agree to be involved in the observational study. He/she decides, with input from his/her surgeon, to have his/her acetabular fracture treated by open reduction internal fixation with primary total hip arthroplasty. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Reduction internal Fixation | Procedure | A surgeon uses hardware, such as plates and screws, to restore structural integrity and alignment of an acetabular fracture. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure for this study is the proportion of complications in the first 12 months following surgery | Researchers will assess treatment success using a two-group comparison of proportion of complications between the treatment groups during the first 12 months following treatment. Complications will be identified by radiographic and clinical evaluation during standard follow-up appointments with the treating surgeon. Complications include postoperative infections, non-union, mal-union, development of heterotopic bone, development of osteoarthritis, osteolysis, hardware failure, hip dislocations, surgical revisions, and any other condition related to surgical treatment of the study injury. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| A secondary outcome for this study is to evaluate patient reported outcomes using the WOMAC Questionnaire. | All enrolled patients complete WOMAC questionnaire 6 and 12 months after surgical treatment. Patient reported outcomes are based on scores on the WOMAC questionnaire. Using a mean of 50 and a standard deviation of 10, this study will have 80% power to detect a 10% change in the patient satisfaction questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theodore Manson, MD | Associate Professor of Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Department of Orthopaedics | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14574190 | Background | Anglen JO, Burd TA, Hendricks KJ, Harrison P. The "Gull Sign": a harbinger of failure for internal fixation of geriatric acetabular fractures. J Orthop Trauma. 2003 Oct;17(9):625-34. doi: 10.1097/00005131-200310000-00005. | |
| 19047701 | Background | Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures Investigators; Bhandari M, Guyatt G, Tornetta P 3rd, Schemitsch EH, Swiontkowski M, Sanders D, Walter SD. Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures. J Bone Joint Surg Am. 2008 Dec;90(12):2567-78. doi: 10.2106/JBJS.G.01694. |
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Patients will be randomized t wo treatment groups : 1. Open reduction internal fixation (ORIF) 2. Acute primary total hip athroplasty (THA) +ORIF. These are both two standard accepted treatments for this injury. Participants who do not consent to being randomized will be asked if they would consent to participating in an observational arm. In this case, type of surgery would be planned and chosen by clinical decision making from the surgeon and patient. As these procedures are both standard of care, partipants could end up in either group as well. All follow up will be the same.
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The individual administering the WOMAC or SF-36 will be blinded to the patient's treatment arm.
| Open Reduction Internal Fixation with Total Hip Arthroscopy | Procedure | A surgeon uses hardware, such as plates and screws, to restore structural integrity and alignment of an acetabular fracture, and replaces the cartilage and bone of the greater trochanter with prosthetic components. |
|
| 6 months and 12 months |
| A secondary outcome for this study is to evaluate patient reported outcomes using the SF36 Questionnaire. | All enrolled patients complete SF36 questionnaire 6 and 12 months after surgical treatment. Patient reported outcomes are based on scores on the SF36 questionnaire. Using a mean of 50 and a standard deviation of 10, this study will have 80% power to detect a 10% change in the patient satisfaction questionnaire. | 6 months and 12 months |
| 19318866 | Background | Boraiah S, Ragsdale M, Achor T, Zelicof S, Asprinio DE. Open reduction internal fixation and primary total hip arthroplasty of selected acetabular fractures. J Orthop Trauma. 2009 Apr;23(4):243-8. doi: 10.1097/BOT.0b013e3181923fb8. |
| 12377902 | Background | Buckley R, Tough S, McCormack R, Pate G, Leighton R, Petrie D, Galpin R. Operative compared with nonoperative treatment of displaced intra-articular calcaneal fractures: a prospective, randomized, controlled multicenter trial. J Bone Joint Surg Am. 2002 Oct;84(10):1733-44. doi: 10.2106/00004623-200210000-00001. |
| 18751805 | Background | Cornell CN. Management of acetabular fractures in the elderly patient. HSS J. 2005 Sep;1(1):25-30. doi: 10.1007/s11420-005-0101-7. |
| 1624491 | Background | Helfet DL, Borrelli J Jr, DiPasquale T, Sanders R. Stabilization of acetabular fractures in elderly patients. J Bone Joint Surg Am. 1992 Jun;74(5):753-65. |
| 20418734 | Background | Herscovici D Jr, Lindvall E, Bolhofner B, Scaduto JM. The combined hip procedure: open reduction internal fixation combined with total hip arthroplasty for the management of acetabular fractures in the elderly. J Orthop Trauma. 2010 May;24(5):291-6. doi: 10.1097/BOT.0b013e3181b1d22a. |
| 9208835 | Background | Jimenez ML, Tile M, Schenk RS. Total hip replacement after acetabular fracture. Orthop Clin North Am. 1997 Jul;28(3):435-46. doi: 10.1016/s0030-5898(05)70300-x. |
| 18784099 | Background | Kirkley A, Birmingham TB, Litchfield RB, Giffin JR, Willits KR, Wong CJ, Feagan BG, Donner A, Griffin SH, D'Ascanio LM, Pope JE, Fowler PJ. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2008 Sep 11;359(11):1097-107. doi: 10.1056/NEJMoa0708333. |
| 11792772 | Background | Mears DC, Velyvis JH. Acute total hip arthroplasty for selected displaced acetabular fractures: two to twelve-year results. J Bone Joint Surg Am. 2002 Jan;84(1):1-9. doi: 10.2106/00004623-200201000-00001. |
| 8934477 | Background | Matta JM. Fractures of the acetabulum: accuracy of reduction and clinical results in patients managed operatively within three weeks after the injury. J Bone Joint Surg Am. 1996 Nov;78(11):1632-45. |
| 12110735 | Background | Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002 Jul 11;347(2):81-8. doi: 10.1056/NEJMoa013259. |
| 12553506 | Background | Mouhsine E, Garofalo R, Borens O, Fischer JF, Crevoisier X, Pelet S, Blanc CH, Leyvraz PF. Acute total hip arthroplasty for acetabular fractures in the elderly: 11 patients followed for 2 years. Acta Orthop Scand. 2002 Dec;73(6):615-8. doi: 10.1080/000164702321039552. |
| 22874118 | Background | Osgood GM, Manson TT, O'Toole RV, Turen CH. Combined pelvic ring disruption and acetabular fracture: associated injury patterns in 40 patients. J Orthop Trauma. 2013 May;27(5):243-7. doi: 10.1097/BOT.0b013e31826c2751. |
| 18519312 | Background | O'Toole RV, Castillo RC, Pollak AN, MacKenzie EJ, Bosse MJ; LEAP Study Group. Determinants of patient satisfaction after severe lower-extremity injuries. J Bone Joint Surg Am. 2008 Jun;90(6):1206-11. doi: 10.2106/JBJS.G.00492. |
| 23719343 | Background | O'Toole RV, Hui E, Chandra A, Nascone JW. How often does open reduction and internal fixation of geriatric acetabular fractures lead to hip arthroplasty? J Orthop Trauma. 2014 Mar;28(3):148-53. doi: 10.1097/BOT.0b013e31829c739a. |
| 9917607 | Background | Pellicci PM, Bostrom M, Poss R. Posterior approach to total hip replacement using enhanced posterior soft tissue repair. Clin Orthop Relat Res. 1998 Oct;(355):224-8. doi: 10.1097/00003086-199810000-00023. |
| 18534534 | Background | Ranawat A, Zelken J, Helfet D, Buly R. Total hip arthroplasty for posttraumatic arthritis after acetabular fracture. J Arthroplasty. 2009 Aug;24(5):759-67. doi: 10.1016/j.arth.2008.04.004. Epub 2008 Jun 4. |
| 2211750 | Background | Romness DW, Lewallen DG. Total hip arthroplasty after fracture of the acetabulum. Long-term results. J Bone Joint Surg Br. 1990 Sep;72(5):761-4. doi: 10.1302/0301-620X.72B5.2211750. |
| 20386286 | Background | Schulman JE, O'Toole RV, Castillo RC, Manson T, Sciadini MF, Whitney A, Pollak AN, Nascone JW. Pelvic ring fractures are an independent risk factor for death after blunt trauma. J Trauma. 2010 Apr;68(4):930-4. doi: 10.1097/TA.0b013e3181cb49d1. |
| 7118986 | Background | Stauffer RN. Ten-year follow-up study of total hip replacement. J Bone Joint Surg Am. 1982 Sep;64(7):983-90. |
| 2584245 | Background | Spencer RF. Acetabular fractures in older patients. J Bone Joint Surg Br. 1989 Nov;71(5):774-6. doi: 10.1302/0301-620X.71B5.2584245. |
| 15517858 | Background | Toro JB, Hierholzer C, Helfet DL. Acetabular fractures in the elderly. Bull Hosp Jt Dis. 2004;62(1-2):53-7. No abstract available. |
| 9759814 | Background | Weber M, Berry DJ, Harmsen WS. Total hip arthroplasty after operative treatment of an acetabular fracture. J Bone Joint Surg Am. 1998 Sep;80(9):1295-305. doi: 10.2106/00004623-199809000-00008. |
| 17119141 | Background | Weinstein JN, Lurie JD, Tosteson TD, Skinner JS, Hanscom B, Tosteson AN, Herkowitz H, Fischgrund J, Cammisa FP, Albert T, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort. JAMA. 2006 Nov 22;296(20):2451-9. doi: 10.1001/jama.296.20.2451. |
| 18287602 | Background | Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):794-810. doi: 10.1056/NEJMoa0707136. |
| 17538085 | Background | Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007 May 31;356(22):2257-70. doi: 10.1056/NEJMoa070302. |
| 28389758 | Background | Walley KC, Appleton PT, Rodriguez EK. Comparison of outcomes of operative versus non-operative treatment of acetabular fractures in the elderly and severely comorbid patient. Eur J Orthop Surg Traumatol. 2017 Jul;27(5):689-694. doi: 10.1007/s00590-017-1949-1. Epub 2017 Apr 7. |
| 27575037 | Background | Shah SB, Manson TT, Nascone JW, Sciadini MF, O'Toole RV. Radiographic Determinants of Early Failure After Posterior Wall Acetabular Fracture Fixation. Orthopedics. 2016 Nov 1;39(6):e1104-e1111. doi: 10.3928/01477447-20160819-03. Epub 2016 Aug 30. |
| 20945123 | Background | Sterling RS, Krushinski EM, Pellegrini VD Jr. THA after acetabular fracture fixation: is frozen section necessary? Clin Orthop Relat Res. 2011 Feb;469(2):547-51. doi: 10.1007/s11999-010-1612-1. |
| 22495529 | Background | Manson TT, Perdue PW, Pollak AN, O'Toole RV. Embolization of pelvic arterial injury is a risk factor for deep infection after acetabular fracture surgery. J Orthop Trauma. 2013 Jan;27(1):11-5. doi: 10.1097/BOT.0b013e31824d96f6. |
| 20938275 | Background | Manson TT, Nascone JW, Sciadini MF, O'Toole RV. Does fracture pattern predict death with lateral compression type 1 pelvic fractures? J Trauma. 2010 Oct;69(4):876-9. doi: 10.1097/TA.0b013e3181e785bf. |
| 20871243 | Background | Manson TT, Nascone JW, O'Toole RV. Traction vertical shear pelvic ring fracture: a marker for severe arterial injury? A case report. J Orthop Trauma. 2010 Oct;24(10):e90-4. doi: 10.1097/BOT.0b013e3181dc2443. |