Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will investigate the incidence and severity of anterior knee pain comparing two different approaches to tibial nail fixation; Infrapatellar versus percutaneous semi-extended suprapatellar incisions. Half the patients will be randomized to the gold standard infrapatellar approach with the other half being randomized to treatment with the percutaneous semi-extended suprapatellar approach.
There are a number of ways to approach the tibial canal when using an intramedullary nail for fracture fixation.
The gold standard is the infrapatellar approach (below the knee cap). This approach has the patient positioned with the knee flexed at 90 degrees or greater on the operating table. However, there are challenges with this approach, including imaging, placement of supplemental fixation, conversion to open reduction when necessary and malunion with apex anterior angulation for proximal tibial fractures. The positioning of the patient causes tension on the structures and soft tissues around the knee which can hinder the placement of the nail and can cause damage to the soft tissues that can result in significant long-term anterior knee pain for many patients.
The semi-extended suprapatellar approach has the patient positioned in approximately 15-20 degrees of flexion, putting less tension on the structures and soft tissues about the knee and enables the surgeon to insert the nail in an optimal position with relative ease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infrapatellar approach | Active Comparator | Infrapatellar approach using the surgeon's incision of choice (i.e., patellar tendon split, tendon retraction medial, tendon retraction lateral). |
|
| Semi-extended suprapatellar approach | Experimental | Semi-extended suprapatellar approach using quadriceps split combined with purpose designed suprapatellar percutaneous instrumentation (patellofemoral protection sleeve). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infrapatellar Approach | Procedure | Infrapatellar approach using the surgeon's incision of choice (i.e. patellar tendon split, tendon retraction medial, tendon retraction lateral) |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS (visual analog scale) for pain on kneeling/ability to knee | Participants assessment of their degree/level of pain on kneeling after performing the AKT (Aberdeen Kneeling Weight-Distribution Test) on a 10 cm visual analog scale | 12 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| AKT (Aberdeen Kneeling Weight-Distribution Test) | The AKT involves kneeling on two separate calibrated scales for up to 60 seconds with the patient blinded to the readings. At 15-second intervals the weight distribution, measured in kg, between the two knees is documented. | 4, 6, 12 and 24 months post treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Darius G Viskontas, MD, FRCSC | Royal Columbian Hospital / Fraser Health Authority | Principal Investigator |
| Trevor B Stone, MD, FRCSC | Royal Columbian Hospital / Fraser Health Authority | Principal Investigator |
| Alan Johnstone, Professor | Aberdeen Royal Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | Canada | |||
| Royal Columbian Hospital / Fraser Health Authority |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10831746 | Background | Karachalios T, Babis G, Tsarouchas J, Sapkas G, Pantazopoulos T. The clinical performance of a small diameter tibial nailing system with a mechanical distal aiming device. Injury. 2000 Jul;31(6):451-9. doi: 10.1016/s0020-1383(00)00024-3. | |
| 11940618 | Background | Toivanen JA, Vaisto O, Kannus P, Latvala K, Honkonen SE, Jarvinen MJ. Anterior knee pain after intramedullary nailing of fractures of the tibial shaft. A prospective, randomized study comparing two different nail-insertion techniques. J Bone Joint Surg Am. 2002 Apr;84(4):580-5. doi: 10.2106/00004623-200204000-00011. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| D046788 | Patellofemoral Pain Syndrome |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D007592 | Joint Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Suprapatellar Approach | Procedure | Semi-extended suprapatellar approach using quadriceps split combined with purpose designed percutaneous instrumentation |
|
| AST (Aberdeen Standing Weight-Distribution Test) |
The AST involves the patient standing on two separate calibrated scales (one foot on each scale) and the weight in kg recorded with the patient blinded to the readings. |
| 4, 6, 12 and 24 months post treatment |
| VAS (Visual Analog Scale) at rest, with walking and descending stairs | Participants overall assessment of their pain at rest, with walking and descending stairs over the past week on a 10 cm visual analog scale | 4, 6, 12 and 24 months post treatment |
| Lysholm Knee Scoring Scale | Used to evaluate outcomes of knee ligament surgery using 8-items commonly affecting patients with anterior knee pain: Limp, support, locking, instability, pain, swelling, stair climbing and squatting. | 4, 6, 12 and 24 months post treatment |
| PKPM (Photographic knee pain map) | Used to determine the precise location of the knee pain, as indicated and localized by the participant. | 4, 6,12 and 24 months post treatment |
| EQ-5D Health Related Quality of Life Outcome Measure | 5 dimensions: Mobility: self-care, usual activities, pain/discomfort and anxiety/depression | 4, 6,12 and 24 months post treatment |
| WPAI:SHP (Work Productivity and Activity Impairment: Specific Health Problem | A questionnaire pertaining to the effect of the participants tibial fracture on their ability to work and perform regular activities. | 4, 6, 12 and 24 months post treatment |
| Radiographic outcome | Blinded independent reviewer will adjudicate alignment, nail position and determination of union at one year, as well as change of position of the nail. | Intra-operatively and 4, 6,12 and 24 months post treatment |
| New Westminster |
| British Columbia |
| V3L 3W7 |
| Canada |
| Hamilton Health Sciences | Hamilton | Ontario | L8L 8E7 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1Y 4E9 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5C 1R6 | Canada |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| 16645100 | Background | Katsoulis E, Court-Brown C, Giannoudis PV. Incidence and aetiology of anterior knee pain after intramedullary nailing of the femur and tibia. J Bone Joint Surg Br. 2006 May;88(5):576-80. doi: 10.1302/0301-620X.88B5.16875. No abstract available. |
| 19359927 | Background | Weninger P, Schultz A, Traxler H, Firbas W, Hertz H. Anatomical assessment of the Hoffa fat pad during insertion of a tibial intramedullary nail--comparison of three surgical approaches. J Trauma. 2009 Apr;66(4):1140-5. doi: 10.1097/TA.0b013e318169cd4d. |
| 1650401 | Background | Koval KJ, Clapper MF, Brumback RJ, Ellison PS Jr, Poka A, Bathon GH, Burgess AR. Complications of reamed intramedullary nailing of the tibia. J Orthop Trauma. 1991;5(2):184-9. doi: 10.1097/00005131-199105020-00011. |
| 24751605 | Background | Ryan SP, Steen B, Tornetta P 3rd. Semi-extended nailing of metaphyseal tibia fractures: alignment and incidence of postoperative knee pain. J Orthop Trauma. 2014 May;28(5):263-9. doi: 10.1097/BOT.0000000000000083. |
| 24464093 | Background | Jones M, Parry M, Whitehouse M, Mitchell S. Radiologic outcome and patient-reported function after intramedullary nailing: a comparison of the retropatellar and infrapatellar approach. J Orthop Trauma. 2014 May;28(5):256-62. doi: 10.1097/BOT.0000000000000070. |
| 15891539 | Background | Vaisto O, Toivanen J, Paakkala T, Jarvela T, Kannus P, Jarvinen M. Anterior knee pain after intramedullary nailing of a tibial shaft fracture: an ultrasound study of the patellar tendons of 36 patients. J Orthop Trauma. 2005 May-Jun;19(5):311-6. |
| 21962297 | Background | Leliveld MS, Verhofstad MH. Injury to the infrapatellar branch of the saphenous nerve, a possible cause for anterior knee pain after tibial nailing? Injury. 2012 Jun;43(6):779-83. doi: 10.1016/j.injury.2011.09.002. Epub 2011 Oct 1. |
| 17620996 | Background | Cartwright-Terry M, Snow M, Nalwad H. The severity and prediction of anterior knee pain post tibial nail insertion. J Orthop Trauma. 2007 Jul;21(6):381-5. doi: 10.1097/BOT.0b013e3180caa138. |
| 18545115 | Background | Vaisto O, Toivanen J, Kannus P, Jarvinen M. Anterior knee pain after intramedullary nailing of fractures of the tibial shaft: an eight-year follow-up of a prospective, randomized study comparing two different nail-insertion techniques. J Trauma. 2008 Jun;64(6):1511-6. doi: 10.1097/TA.0b013e318031cd27. |
| 8653954 | Background | Tornetta P 3rd, Collins E. Semiextended position of intramedullary nailing of the proximal tibia. Clin Orthop Relat Res. 1996 Jul;(328):185-9. doi: 10.1097/00003086-199607000-00029. |
| 25046413 | Background | Sanders RW, DiPasquale TG, Jordan CJ, Arrington JA, Sagi HC. Semiextended intramedullary nailing of the tibia using a suprapatellar approach: radiographic results and clinical outcomes at a minimum of 12 months follow-up. J Orthop Trauma. 2014 Aug;28 Suppl 8:S29-39. doi: 10.1097/01.bot.0000452787.80923.ee. |
| 20205366 | Background | Morandi M, Banka T, Gaiarsa GP, Guthrie ST, Khalil J, Hoegler J, Lindeque BG. Intramedullary nailing of tibial fractures: review of surgical techniques and description of a percutaneous lateral suprapatellar approach. Orthopedics. 2010 Mar;33(3):172-9. doi: 10.3928/01477447-20100129-22. No abstract available. |
| 20881632 | Background | Kubiak EN, Widmer BJ, Horwitz DS. Extra-articular technique for semiextended tibial nailing. J Orthop Trauma. 2010 Nov;24(11):704-8. doi: 10.1097/BOT.0b013e3181d5d9f4. |
| 9057144 | Background | Court-Brown CM, Gustilo T, Shaw AD. Knee pain after intramedullary tibial nailing: its incidence, etiology, and outcome. J Orthop Trauma. 1997 Feb-Mar;11(2):103-5. doi: 10.1097/00005131-199702000-00006. |
| 22068208 | Background | Song SY, Chang HG, Byun JC, Kim TY. Anterior knee pain after tibial intramedullary nailing using a medial paratendinous approach. J Orthop Trauma. 2012 Mar;26(3):172-7. doi: 10.1097/BOT.0b013e3182217fe6. |
| 26665254 | Background | Courtney PM, Boniello A, Donegan D, Ahn J, Mehta S. Functional Knee Outcomes in Infrapatellar and Suprapatellar Tibial Nailing: Does Approach Matter? Am J Orthop (Belle Mead NJ). 2015 Dec;44(12):E513-6. |
| 15316121 | Background | Garratt AM, Brealey S, Gillespie WJ; DAMASK Trial Team. Patient-assessed health instruments for the knee: a structured review. Rheumatology (Oxford). 2004 Nov;43(11):1414-23. doi: 10.1093/rheumatology/keh362. Epub 2004 Aug 17. |
| 6896798 | Background | Lysholm J, Gillquist J. Evaluation of knee ligament surgery results with special emphasis on use of a scoring scale. Am J Sports Med. 1982 May-Jun;10(3):150-4. doi: 10.1177/036354658201000306. |
| 4028566 | Background | Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9. |
| 20850976 | Background | Elson DW, Jones S, Caplan N, Stewart S, St Clair Gibson A, Kader DF. The photographic knee pain map: locating knee pain with an instrument developed for diagnostic, communication and research purposes. Knee. 2011 Dec;18(6):417-23. doi: 10.1016/j.knee.2010.08.012. Epub 2010 Sep 17. |
| 19386310 | Background | Leighton RK, Trask K. The Canadian Orthopaedic Trauma Society: a model for success in orthopaedic research. Injury. 2009 Nov;40(11):1131-6. doi: 10.1016/j.injury.2008.11.021. Epub 2009 Apr 21. |
| 15129407 | Background | Crossley KM, Bennell KL, Cowan SM, Green S. Analysis of outcome measures for persons with patellofemoral pain: which are reliable and valid? Arch Phys Med Rehabil. 2004 May;85(5):815-22. doi: 10.1016/s0003-9993(03)00613-0. |
| 20216463 | Background | Mills K, Blanch P, Vicenzino B. Identifying clinically meaningful tools for measuring comfort perception of footwear. Med Sci Sports Exerc. 2010 Oct;42(10):1966-71. doi: 10.1249/MSS.0b013e3181dbacc8. |
| 25268438 | Background | Hinman RS, McCrory P, Pirotta M, Relf I, Forbes A, Crossley KM, Williamson E, Kyriakides M, Novy K, Metcalf BR, Harris A, Reddy P, Conaghan PG, Bennell KL. Acupuncture for chronic knee pain: a randomized clinical trial. JAMA. 2014 Oct 1;312(13):1313-22. doi: 10.1001/jama.2014.12660. |
| D009140 |
| Musculoskeletal Diseases |