Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails

NCT01358292 | Completed Phase 4 DMC

• 1 other identifier: R11021-1
• Study Type: interventional
• Target: 95
• Locations: 3 countries
• Sites: 5

Brief Summary

Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for extra-articular tibial fractures treated with Smith\& Nephew's Trigen META intramedullary nailing system; comparing two surgical techniques: Group A=standard technique(90º of knee flexion) and Group B=with the semi-extended surgical technique. (2\*100 patients) Research Objectives: The primary research objectives are to evaluate: i) anterior knee pain and ii) the nail position and overall fracture alignment Outcome Measures:

1. 1.Nail positioning by means of intra-operative fluoroscopy and post operative x-rays.
2. 2.Anterior Knee pain by means of VAS-scores, a Kneeling test and Subjective outcomes by means of Patient questionnaires
3. 3.Knee-related adverse events
4. 4.Overall fracture alignment

Conditions

Tibial Fractures

Keywords

Intramedullary tibia nailing; Anterior Knee Pain; Nail positioning

Outcome Measures

Primary Outcomes (1)

• Anterior Knee Pain

  Anterior Knee pain will be measured through a Kneeling test (time a patient is able to rest on his operated knee)

  4, 6 and 12 months post-operative

Secondary Outcomes (1)

• Nail positioning

  Operation (day 1)

Study Arms (2)

Semi-extended surgical technique

EXPERIMENTAL

The experimental technique for implanting an intramedullary tibia nail is with the knee in 10-20 degrees of flexion.

Procedure: Semi-extended Surgical Technique

Standard Surgical Technique

ACTIVE COMPARATOR

The standard surgical technique in intramedullary tibia nailing is with the knee in almost 90 degrees of flexion.

Procedure: Standard Surgical Technique

Interventions

Semi-extended Surgical Technique PROCEDURE

Surgical technique with the knee in 10-20 degrees of flexion, to implant the intramedullary tibia nail.

Also known as: Trigen META Intramedullray Tibia Nail

Semi-extended surgical technique

Standard Surgical Technique PROCEDURE

Th e Standard surgical techique is implanting the tibia nail with the knee in 90 degrees of flexion.

Also known as: Trigen META intramedullary tibia nailing

Standard Surgical Technique

Eligibility Criteria

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

You may qualify if:

• Patient has sustained a closed (Tscherne Classification) or open tibial fracture (Gustillo-Anderson Classification) that is amendable for operative fixation with an intramedullary nail.
• Patient has an isolated tibia and fibula fracture
• Skeletally mature
• Patients aged between/including 18 to 70 years
• Patient has given formal consent to be involved in the trial and has completed the study consent form
• Patient is likely to comply with study follow-up requirements

You may not qualify if:

• Pathologic fractures
• Other fractures involving the same lower extremity
• Soft tissue injuries/problems that would prevent the surgeon from using both of the surgical techniques to insert an intramedullary nail
• Patient having pre-existing knee joint disease causing anterior knee pain
• Patient likely to have problems with follow-up
• Patient unwilling to give informed consent to be included in the trial

Sponsors & Collaborators

• Smith & Nephew Orthopaedics AG: lead

Study Sites (5)

Medizinisches Zentrum StädteRegion Aachen

Würselen, 52146, Germany

Location

Hoisptal de 12 Octubre

Madrid, 28041, Spain

Location

Hospital La Fe

Valencia, 46009, Spain

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Nottingham University Hospitals

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Alan Johnstone, Professor

  Aberdeen Royal Infirmary

  PRINCIPAL INVESTIGATOR

• Pedro Caba, Dr.

  Hospital de 12 Octubre, Madrid

  STUDY CHAIR

• Markus Graf, Dr.

  Medizinisches Zentrum StädteRegion Aachen

  STUDY CHAIR

• Ismael Escriba, Dr.

  Hospital La Fe de Valencia

  STUDY CHAIR

• Daren Forward, MA, FRCS, DM

  Nottingham University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: May 23, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 17, 2016

Record last verified: 2015-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); GB (2); ES (2)