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AzTrials

Tibia FractureNCT03649360

Knee Pain After Intramedullary Nailing in the Tibia

An observational study of Tibia Fracture and Knee Pain Chronic, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tibia Fracture, Knee Pain Chronic
How many people
223 participants
Where
1 siteDenmark
Study dates
1 Nov 2009to 15 Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients who underwent surgery with reamed, locked intramedullary nailing after isolated tibial shaft fracture at one of the above mentioned orthopedic departments between 1st of November 2009 and 30th of October 2014 were sought.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Copenhagen University Hospital of Hvidovre

    Hvidovre, 2650

Other trials in Denmark

About this study

Official title: 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 intramedullary nail in patients with a tibial shaft fracture using an injury-specific questionnaire.

Read the detailed 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.

Keywords
Knee pain, Intramedullary tibial nail, KOOS
Medical subject headings
Tibial Fractures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1st of November 2009 till 30th of October 2014.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2018
  2. Study start1 Nov 2009
  3. Primary completion31 Oct 2014
  4. Study completion15 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03649360
Sponsor's protocol ID
IMN Study
Status last verified
Aug 2018
First submitted
23 Aug 2018
Last updated
28 Aug 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan of sharing data.

Publications

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

    PubMed 3733776

  • 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. doi: 10.2106/00004623-199709000-00007.

    PubMed 9314395

  • 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.

    PubMed 9057144

  • 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. doi: 10.5435/00124635-201111000-00005.

    PubMed 22052645

  • 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.

    PubMed 18758282

  • 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.

    PubMed 11940618

  • 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. doi: 10.1080/000164700317413139.

    PubMed 10852322

  • 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.

    PubMed 20205366

  • 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.

    PubMed 10831746

  • 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.

    PubMed 16645100

  • 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.

    PubMed 18545115

  • 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. doi: 10.1097/00005131-200211000-00001.

    PubMed 12439190

  • 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.

    PubMed 19359927

  • 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. doi: 10.1302/0301-620x.82b1.9818.

    PubMed 10697311

  • 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. No abstract available.

    PubMed 7593119

Questions about this trial

What is this clinical trial studying?

An observational study of Tibia Fracture and Knee Pain Chronic, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee Pain after Tibial Shaft Fracture Treated with Intramedullary Nailing (time frame: 1st of November 2009 till 30th of October 2014.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03649360, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.

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