INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia

Tibial Fractures Clinical Trial

— INSURT  

Official title:

INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750072
• Other study ID #: FHREB #: 2016-029
• Status: Completed
• Phase: N/A
• Start date: September 13, 2016
• Est. completion date: October 12, 2023

Study information

• Verified date: September 2023
• Source: Fraser Orthopaedic Research Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: October 12, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• all extra-articular tibial fractures

• simple distal tibial intra-articular fractures amenable to IMN

• open and closed fractures

• bilateral tibiae

• willing and able to consent, follow protocol and attend follow-up visits

• able to read and understand English or have interpreter available

Exclusion Criteria:

• patients with contralateral femur and/or hip fracture requiring retrograde IMN

• patients with contralateral knee injuries that would impair their ability to kneel during the follow-up period

• associated knee injury

• previous symptomatic knee pathology

• ipsilateral injuries to the same limb that would interfere with rehab or outcome

• neurovascular injuries at the level of the knee requiring surgery

• open or closed fractures > 14 days (times of injury to OR)

• non unions

• pathologic fractures

• periprosthetic fractures

• spinal injury

• non-ambulatory patients

• incarceration

• limited life expectancy due to significant medical co-morbidities or medical contra-indication to surgery (pregnancy)

• likely problems, in the judgment of the investigators, with maintaining follow-up

Related Conditions & MeSH terms

• Anterior Knee Pain Syndrome
• Fractures, Bone
• Patellofemoral Pain Syndrome
• Tibial Fractures

Intervention

Procedure:
• Infrapatellar Approach
Infrapatellar approach using the surgeon's incision of choice (i.e. patellar tendon split, tendon retraction medial, tendon retraction lateral)
• Suprapatellar Approach
Semi-extended suprapatellar approach using quadriceps split combined with purpose designed percutaneous instrumentation

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	Royal Columbian Hospital / Fraser Health Authority	New Westminster	British Columbia
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fraser Orthopaedic Research Society

Countries where clinical trial is conducted

Canada,  Spain, 

References & Publications (26)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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