Knee Pain After Intramedullary Nailing in the Tibia

Knee Pain Chronic Clinical Trial

Official title:

Knee Pain After Tibial Shaft Fracture Treated With Intramedullary Nailing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03649360
• Other study ID #: IMN Study
• Status: Completed
• Start date: November 1, 2009
• Est. completion date: December 15, 2016

Study information

• Verified date: August 2018
• Source: Copenhagen University Hospital, Hvidovre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to evaluate the long-term outcome after inserting an intramedullary nail in patients with a tibial shaft fracture using an injury-specific questionnaire.

Description:

Introduction

The treatment of choice for unstable diaphyseal fractures in the tibia is reamed insertion of an intramedullary nail (IMN) with the additional placement of interlocking screws. The most common complication after insertion of an IMN as treatment of tibial shaft fractures is chronic knee pain with reported rates between 10 % and 87 % with a mean of 47,4 % in metaanalyses.

Methods

The primary objective of this study is to evaluate the long-term outcome after inserting an IMN in patients with a tibial shaft fracture using an injury-specific questionnaire.

This study includes patients operated on five Danish hospitals. A database search was made using operational codes for insertion of an IMN in a five-year period. Patients aged 18 years or older, alive and residing in Denmark at the time of follow-up could be included in the study. These patients then received a Knee Injury and Osteoarthritis Score (KOOS) questionnaire by mail with questions regarding knee-specific symptoms, stiffness, pain, function and quality of life. Questionnaires were filled out and returned to the corresponding physician for further analyze. Patients who were unable to fill out the questionnaire due to concomitant physical condition or who had undergone amputation or further surgery on the affected limb were excluded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: December 15, 2016
• Est. primary completion date: October 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 years or older, alive and residing in Denmark at the time of follow-up could be included in the study.

Exclusion Criteria:

• Patients who were unable to fill out the questionnaire due to concomitant physical condition or who had undergone amputation or further surgery on the affected limb were excluded.

Related Conditions & MeSH terms

• Knee Pain Chronic
• Tibia Fracture
• Tibial Fractures

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital of Hvidovre	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

References & Publications (22)

Althausen PL, Neiman R, Finkemeier CG, Olson SA. Incision placement for intramedullary tibial nailing: an anatomic study. J Orthop Trauma. 2002 Nov-Dec;16(10):687-90. — View Citation

Bhattacharyya T, Seng K, Nassif NA, Freedman I. Knee pain after tibial nailing: the role of nail prominence. Clin Orthop Relat Res. 2006 Aug;449:303-7. — View Citation

Bone LB, Johnson KD. Treatment of tibial fractures by reaming and intramedullary nailing. J Bone Joint Surg Am. 1986 Jul;68(6):877-87. — View Citation

Bone LB, Sucato D, Stegemann PM, Rohrbacher BJ. Displaced isolated fractures of the tibial shaft treated with either a cast or intramedullary nailing. An outcome analysis of matched pairs of patients. J Bone Joint Surg Am. 1997 Sep;79(9):1336-41. — 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. — View Citation

Demirtas A, Azboy I, Durakbasa MO, Uçar BY, Mercan AS, Cakir IA. [The relationship between the quadriceps muscle strength and the anterior knee pain occurring after locked intramedullary nailing for tibial diaphysis fractures]. Eklem Hastalik Cerrahisi. 2011 Aug;22(2):81-4. Turkish. — View Citation

Hernigou P, Cohen D. Proximal entry for intramedullary nailing of the tibia. The risk of unrecognised articular damage. J Bone Joint Surg Br. 2000 Jan;82(1):33-41. — View Citation

Hiesterman TG, Shafiq BX, Cole PA. Intramedullary nailing of extra-articular proximal tibia fractures. J Am Acad Orthop Surg. 2011 Nov;19(11):690-700. Review. — 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. — View Citation

Karladani AH, Granhed H, Edshage B, Jerre R, Styf J. Displaced tibial shaft fractures: a prospective randomized study of closed intramedullary nailing versus cast treatment in 53 patients. Acta Orthop Scand. 2000 Apr;71(2):160-7. — 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. Review. — View Citation

Lefaivre KA, Guy P, Chan H, Blachut PA. Long-term follow-up of tibial shaft fractures treated with intramedullary nailing. J Orthop Trauma. 2008 Sep;22(8):525-9. doi: 10.1097/BOT.0b013e318180e646. — View Citation

Lottes JO. Medullary nailing of the tibia with the triflange nail. Clin Orthop Relat Res. 1974 Nov-Dec;(105):53-66. — 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. Review. — View Citation

Orfaly R, Keating JE, O'Brien PJ. Knee pain after tibial nailing: does the entry point matter? J Bone Joint Surg Br. 1995 Nov;77(6):976-7. — View Citation

Paradowski PT, Bergman S, Sundén-Lundius A, Lohmander LS, Roos EM. Knee complaints vary with age and gender in the adult population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS). BMC Musculoskelet Disord. 2006 May 2;7:38. — View Citation

Ryan SP, Tornetta P 3rd, Dielwart C, Kaye-Krall E. Knee pain correlates with union after tibial nailing. J Orthop Trauma. 2011 Dec;25(12):731-5. doi: 10.1097/BOT.0b013e318213f587. — View Citation

Toivanen JA, Väistö O, Kannus P, Latvala K, Honkonen SE, Järvinen 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-A(4):580-5. — View Citation

Väistö O, Toivanen J, Kannus P, Järvinen 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

Väistö O, Toivanen J, Kannus P, Järvinen M. Anterior knee pain and thigh muscle strength after intramedullary nailing of a tibial shaft fracture: an 8-year follow-up of 28 consecutive cases. J Orthop Trauma. 2007 Mar;21(3):165-71. — View Citation

Weller S, Kuner E, Schweikert CH. Medullary nailing according to Swiss study group principles. Clin Orthop Relat Res. 1979 Jan-Feb;(138):45-55. — 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 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Pain after Tibial Shaft Fracture Treated with Intramedullary Nailing	The primary objective of this study is to evaluate the long-term outcome after inserting an IMN in patients with a tibial shaft fracture using an injury-specific questionnaire. We used the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire to collect patient data. It is used to assess patient's subjective opinion about symptoms related to the knee and other associated problems. The questionnaire has been translated and validated in Danish and consists of 5 subscales: pain, symptoms, function in daily living (ADL) function in sports and recreation and knee-related QOL. Each subscale has between 4 and 17 questions (a total of 42 questions) with each question having 5 options ranging from no symptoms to severe symptoms. Each question gets a score from 0-4 and a score from 0-100 is calculated. 100 indicating no symptoms and 0 indicates major symptoms.	1st of November 2009 till 30th of October 2014.

External Links

•   Danish Database of Fractures website. Accessed March 25, 2015.
•   KOOS questionnaire [KOOS web site]. Accessed May 20th 2015.