Intramedullary Nailing vs External Ring Fixation for the Treatment of Tibial Shaft Fractures

NCT03945669 | Completed DMC

• 1 other identifier: LERG1
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 3

Brief Summary

This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial in which standard intramedullary nailing is compared with external ring fixator for patients with tibial shaft fractures.

Conditions

Tibial Shaft Fracture

Keywords

External ring fixation; Intramedullary nailing; Tibial shaft fracture; patient reported outcome

Outcome Measures

Primary Outcomes (1)

• The Knee Injury and Osteoarthritis Outcome Score - sport (KOOS Sport)

  KOOS-sport is a standardized and validated patient-reported instrument used in order to assess knee and knee associated problems with regards to activity. The subscale sport is one five subscales: pain, ADL, symptoms, sport and QOL in the KOOS questionnaire . A total score of 100 indicates no symptoms, and 0 indicates major symptoms.

  12 month follow up

Secondary Outcomes (13)

• Perceived Pain

  6 weeks, 3+6+12 months

• Patient-reported pain reactions

  6 weeks, 3+6+12 months

• Pain sensitivity

  6 weeks, 3+6+12 months

• Muscle strength

  6+12 months

• Time to bone union

  6 weeks, 3+6+12 months

Other Outcomes (1)

• Adverse events

  6 weeks, 3+6+12 months

Study Arms (2)

Intramedullary Nail

ACTIVE COMPARATOR

Intramedullary Nailing: Alignment will be obtained by closed or limited open reduction of the fracture. A standard reamed intramedullary nail is inserted. Access above the patella, through the patella tendon or parapatellar access is used according to surgeon preferences. One or more cortical screws may be used if deemed appropriate due to fracture pattern. Patients are administered preoperative antibiotics (Dicloxacillin) 15 minutes before surgery commences. Postoperative antibiotics is administered by discretion of the surgeon based on individual patient considerations.

Procedure: Intramedullary Nailing

External Ring fixator

EXPERIMENTAL

External Ring fixation: Closed or limited open reduction of the fracture is performed. A circular frame is attached on both sides of the fracture. Connection to the bone is obtained by hydroxyapatite coated half pins and/or k-wires with olives as needed according to surgeon preferences. One or more cortical screws may be used if deemed appropriate due to fracture pattern. After applying the ring fixator alignment is assessed radiologically and corrected both peri- and postoperatively. Patients are administered preoperative antibiotics (Dicloxacillin) preoperatively 15 minutes before surgery commences. Following surgery antibiotics are continued until wounds, pin- and wire perforations are dry.

Procedure: External Ring fixation

Interventions

Intramedullary Nailing PROCEDURE

fracture fixation of the tibial shaft fracture with an intramedullary nail.

Intramedullary Nail

External Ring fixation PROCEDURE

fracture fixation of the tibial shaft fracture with an external ring fixator.

External Ring fixator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fracture of the tibial shaft
• OTA classification Type: 42-A1-A3, -B1-B3 and -C1-C3
• The fracture type is deemed operable by intramedullary nail

You may not qualify if:

• Below 18 years of age
• Open fracture
• History of severe systemic diseases or cancer
• Bilateral tibial shaft fracture
• Multi fracture patients
• Pregnancy
• Patients without gait function prior to fracture

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Danish Council for Independent Research: collaborator

Study Sites (3)

Aalborg University Hospital, Department of orthopaedic surgery

Aalborg, 9000, Denmark

Location

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Regional Hospital Viborg

Viborg, 8800, Denmark

Location

Related Publications (1)

• Larsen P, Stokholm R, Rolfing JD, Petruskevicius J, Rasmussen MK, Jensen SS, Elsoe R. Intramedullary nailing versus external ring fixation for tibial shaft fractures: an explorative analysis of muscle strength from the IMVEX trial. Arch Orthop Trauma Surg. 2025 Jul 18;145(1):379. doi: 10.1007/s00402-025-05995-6.

  PMID: 40679543 DERIVED

MeSH Terms

Interventions

Fracture Fixation, Intramedullary

Intervention Hierarchy (Ancestors)

Fracture Fixation, Internal; Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Rasmus Elsøe, PhD

  Aalborg University Hospital

  STUDY DIRECTOR

• Rasmus Stokholm, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

• Peter Larsen, PhD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the study participants, care providers and investigator can not be blinded. The outcome assessor will be blinded with regards to the two treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Orthopaedic trauma

Model Details: This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial.

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 10, 2019
• Study Start: November 1, 2019
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)