Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures

NCT03388879 | Completed

• 1 other identifier: REKC 2010/1706
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomised, bi-centre, prospective, clinical trial in patients with closed tibia shaft fractures. The fracture should be fresh/acute and seen within 3 weeks after the injury. Patients will be randomised to surgery with either a Taylor Spatial Frame (Smith \& Nephew, England) or a reamed intramedullar nail (according to local choice) with locking screws. Primary outcome measure is the physical component summary (PCS) of RAND Short form 36 (SF-36) after 2 years. Among secondary outcomes: Visual Analogue Scale (VAS) for pain, complications, healing, malunion, and resource use.

Conditions

Tibial Fractures

Outcome Measures

Primary Outcomes (1)

• Physical Component summary of RAND SF 36 (Short Form 36)

  Generic Health Related Quality of Life. Mean value 50, standard deviation 10. Higher score better.

  24 months

Secondary Outcomes (21)

• Vitality Subscore of RAND (SF) 36

  6, 12, 24 months

• Physical functioning, subscore of RAND (SF) 36

  6, 12, 24 months

• Bodily pain, subscore of RAND (SF) 36

  6, 12, 24 months

• General health perceptions, subscore of RAND (SF) 36

  6, 12, 24 months

• Physical role functioning, subscore of RAND (SF) 36

  6, 12, 24 months

Study Arms (2)

Circular frame external fixator

EXPERIMENTAL

A Taylor Spatial Frame should consist of 2 rings with 4 half pins/K-wire attached to each ring. If possible 3, not hydroxyapatite-coated, half pins and one K-wire should be attached to each ring. The half pins/K-wire should be spread in distance and direction for optimum stability.

Device: Taylor Spatial Frame

Intramedullary nail

ACTIVE COMPARATOR

Nailing technique according to Karladani and Styf published technique (ref: Karladani AH, Styf J. Percutaneous intramedullary nailing of tibial shaft fratures: a new approach for prevention of anterior knee pain. Injury, Int. J. Care Injury 32 (2001) 736-39)

Device: Intramedullary nail

Interventions

Taylor Spatial Frame DEVICE

Circular external fixator

Also known as: Circular frame

Circular frame external fixator

Intramedullary nail DEVICE

Antegrade intramedullary nail

Intramedullary nail

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Closed tibia shaft fractures suited for both study treatments.
• A patient who is informed of the purpose of the investigation and who has given informed consent and willingness to accept randomisation either to Taylor Spatial Frame or intramedullary nailing.
• Willingness and ability to comply with all investigation procedures
• Age between 18 to 70 years
• Skeletally mature
• Previous unaided walking

You may not qualify if:

• Participation in other clinical investigations that will interfere with this study
• Mental illness or other conditions that preclude ring fixator in the judgment of the investigator
• Any other concurrent condition(s) that, in the judgment of the investigator, would prohibit the patient from participation in the study
• No other injury or previous disease that would be likely to seriously influence the long term outcome (this will exclude e.g. osteomyelitis, vascular or neurological disorder of the lower extremities, rheumatoid artist, malignancy that could influence on bone healing)
• Compartment syndrome before randomisation
• Pathologic fracture
• Ongoing or previous use the last year of drugs that can be bone anabolic (e.g. anabolic steroids, growth hormone, parathyroid hormone)

Sponsors & Collaborators

• Oslo University Hospital: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Orthopedic Center, Ulleval University Hospital

Oslo, 0408, Norway

Location

MeSH Terms

Conditions

Tibial Fractures

Interventions

Fracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jan E Madsen, PhD

  Professor, head of research group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher doing the statistical analyses will be masked for treatment Group (i.e. Group 1 or 2) in a databse blinded for treatment grioups and without variables indirectly revealing treatmnet arm. These will be analyzed later.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: Prospective randomized two-group clinical trial with block randomization.

Study Record Dates

• First Submitted: December 17, 2017
• First Posted: January 3, 2018
• Study Start: October 31, 2010
• Primary Completion: June 16, 2015
• Study Completion: June 21, 2016
• Last Updated: January 3, 2018

Record last verified: 2017-12

Locations

NO (1)