Clinical Validation of the C-Arm Rotational View (CARV) to Avoid Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures.

NCT05459038 | Unknown

• 1 other identifier: 81191
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief Summary

Tibia shaft fractures are common long bone fractures in the field of Orthopaedic Trauma. In the USA, a total of 492.000 tibial fractures were reported per year by the National Center of Health Statistics (NCHS). Intramedullary nailing (IMN) is the treatment of choice for shaft fractures. However, rotational malalignment (RM) remains an iatrogenic pitfall with a prevalence up to 30%. From a clinical point of view, there is limited knowledge on how to avoid RM during IMN. Clinical estimation of tibial alignment is difficult, resulting frequently in RM following IMN. Low-dose CT-assessment is considered the gold standard to objectify RM, but is performed after surgery when the opportunity for direct revision has passed. Both difficulties in intraoperative clinical judgement of tibial alignment as well as postoperative detection of RM when the possibility for direct revision has passed, do support the need for an easy-to-use intraoperative fluoroscopy protocol to minimize the risk for RM during IMN of tibial shaft fractures. Recently, a standardized intraoperative fluoroscopy protocol named the 'C-Arm Rotational View (CARV)' was determined in order to improve the accuracy of alignment control during IMN of tibial shaft fractures. CARV includes predefined fluoroscopy landmarks of the uninjured side to correct for rotational malalignment of the injured side in which the rotation of the C-Arm Image Intensifier is used. Promising preliminary results were found to reduce the risk on RM following IMN of tibia fractures. However, a prospective trial is needed to determine the performance of CARV in clinical practice. Therefore, a prospective multi-center randomized controlled trial is designed to assess the clinical feasibility and potential benefits of the CARV-protocol. The following primary research question was defined: can the risk for RM following IMN of tibial shaft fractures be minimized by use of the CARV-protocol?

Conditions

Tibial Fractures; Surgery; Complication,Postoperative

Keywords

Intramedullary nailing; Tibia shaft fractures; Rotational malalignment; C-Arm Rotational View; multi-center randomized controlled trial.

Outcome Measures

Primary Outcomes (1)

• Rotational (mal)alignment

  Determine the incidence of RM using postoperative CT-assessment. In literature, RM is defined as a rotation ≥10 degrees relative to the contralateral side. However, considering the physiological left-right difference of 4 degrees between left and right-sided tibiae, with right-sided tibiae on average 4 degrees more externally rotated, RM is defined as malrotation of \< -6 degrees or \>14 degrees in right-sided tibiae and \< -14 degrees or \>6 degrees in left-sided tibiae. A negative angle represents internal rotation and positive angle external rotation.

  Up to 12 months after initial surgery

Study Arms (2)

Interventional group

EXPERIMENTAL

Patients assigned to the interventional group will undergo an identical surgical procedure as patients assigned to the control group. The only difference with the control group is that tibial alignment will be obtained according to the standardized CARV-protocol.

Diagnostic Test: C-Arm Rotational View (CARV)

Control group

NO INTERVENTION

Patients assigned to the control group will undergo an identical surgical procedure as patients assigned to the interventional group. The only difference with the intervention group is that tibial alignment will be obtained according to present unstandardized clinical standards

Interventions

C-Arm Rotational View (CARV) DIAGNOSTIC_TEST

CARV includes predefined fluoroscopy landmarks of the uninjured side to correct for rotational malalignment of the injured side in which the rotation of the C-Arm Image Intensifier is used

Interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive patients (≥18 years) with an open or closed tibia shaft fracture, who are eligible for IMN, will be asked to enroll in the study

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (2)

Flinders Medical Centre, Flinders University

Adelaide, Australia

Location

University Medical Centers Groningen

Groningen, Netherlands

Location

Related Publications (7)

• Theriault B, Turgeon AF, Pelet S. Functional impact of tibial malrotation following intramedullary nailing of tibial shaft fractures. J Bone Joint Surg Am. 2012 Nov 21;94(22):2033-9. doi: 10.2106/JBJS.K.00859.

  PMID: 23172320 BACKGROUND

• Cain ME, Hendrickx LAM, Bleeker NJ, Lambers KTA, Doornberg JN, Jaarsma RL. Prevalence of Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures: Can We Reliably Use the Contralateral Uninjured Side as the Reference Standard? J Bone Joint Surg Am. 2020 Apr 1;102(7):582-591. doi: 10.2106/JBJS.19.00731.

  PMID: 31977824 BACKGROUND

• Bleeker NJ, Cain M, Rego M, Saarig A, Chan A, Sierevelt I, Doornberg JN, Jaarsma RL. Bilateral Low-Dose Computed Tomography Assessment for Post-Operative Rotational Malalignment After Intramedullary Nailing for Tibial Shaft Fractures: Reliability of a Practical Imaging Technique. Injury. 2018 Oct;49(10):1895-1900. doi: 10.1016/j.injury.2018.07.031. Epub 2018 Jul 29.

  PMID: 30097311 BACKGROUND

• Puloski S, Romano C, Buckley R, Powell J. Rotational malalignment of the tibia following reamed intramedullary nail fixation. J Orthop Trauma. 2004 Aug;18(7):397-402. doi: 10.1097/00005131-200408000-00001.

  PMID: 15289683 BACKGROUND

• Bleeker NJ, Reininga IHF, van de Wall BJM, Hendrickx LAM, Beeres FJP, Duis KT, Doornberg JN, Jaarsma RL, Kerkhoffs GMMJ, IJpma FFA. Difference in Pain, Complication Rates, and Clinical Outcomes After Suprapatellar Versus Infrapatellar Nailing for Tibia Fractures? A Systematic Review of 1447 Patients. J Orthop Trauma. 2021 Aug 1;35(8):391-400. doi: 10.1097/BOT.0000000000002043.

  PMID: 34267147 BACKGROUND

• Shih YC, Chau MM, Arendt EA, Novacheck TF. Measuring Lower Extremity Rotational Alignment: A Review of Methods and Case Studies of Clinical Applications. J Bone Joint Surg Am. 2020 Feb 19;102(4):343-356. doi: 10.2106/JBJS.18.01115. No abstract available.

  PMID: 31743239 BACKGROUND

• Bleeker NJ, Doornberg JN, Ten Duis K, El Moumni M, Jaarsma RL, IJpma FFA. Clinical validation of the 'C-arm rotational view (CARV)': study protocol of a prospective randomised controlled trial. BMJ Open. 2023 Nov 22;13(11):e064802. doi: 10.1136/bmjopen-2022-064802.

  PMID: 37993156 DERIVED

MeSH Terms

Conditions

Tibial Fractures; Postoperative Complications

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nils Jan Bleeker, MD

CONTACT

050 361 6161; n.j.bleeker@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-center randomized controlled trial

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: July 14, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); AU (1)