Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-A

NCT04851509 | Recruiting DMC

• 1 other identifier: FHREB#: 2021-015
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate the shortening and collapse of pertrochanteric fractures following surgical management with the TFN-Advanced nailing system. The focus will be on comparing radiographic assessments of nails which have been statically locked versus dynamically locked. This is a randomized control study with the initial invention being randomized to either statically locking or dynamically locking. For a two-month period, all eligible patients will receive the randomized allocated treatment, then treatment will switch to the alternate treatment for the next two months and will continue to alternate treatments for two-month periods until study enrollment has completed.

Conditions

Pertrochanteric Fracture

Outcome Measures

Primary Outcomes (1)

• Radiographic Assessment

  The primary objective of this study will be to investigate how statically locking the TFN-A influences shortening or collapse of pertrochanteric fractures by measuring radiographic shortening or collapse of pertrochanteric fractures treated with the TFN-A implant.

  12 months post treatment

Secondary Outcomes (4)

• Fracture Reduction Quality

  Intra-operatively

• Femoral Offset

  1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months

• Tip-Apex distance

  1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months

• Complications

  intra-operatively, 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months

Study Arms (2)

Dynamic rotational locking

ACTIVE COMPARATOR

Using a fracture table, the affected leg will be placed into traction and the patient will be prepped and draped in the usual fashion. The fracture will be provisionally reduced using closed techniques. A 3cm incision will be used to gain access to the intramedullary canal and the nail (either a short nail or long nail, at the discretion of the treating surgeon) will be introduced to the femur. The screw will be placed across the fracture and into the femoral head, aiming for a tip-to-apex distance less than 25mm. The compression nut will be used to compress the fracture. The screw will be rotationally locked by using the 5mm hex flexible screwdriver by advancing the set screw until it stops completely. The screw will then be turned counterclockwise by a ½ turn.

Procedure: Dynamic Rotational Locking

Static locking

EXPERIMENTAL

Using a fracture table, the affected leg will be placed into traction and the patient will be prepped and draped in the usual fashion. The fracture will be provisionally reduced using closed techniques. A 3cm incision will be used to gain access to the intramedullary canal and the nail (either a short nail or long nail, at the discretion of the treating surgeon) will be introduced to the femur. The screw will be placed across the fracture and into the femoral head, aiming for a tip-to-apex distance of less than 25mm. The compression nut will be used to compress the fracture. The screw will then be statically locked using the 6Nm torque-limiting blue handle with 6mm hex coupling to completely lock the set screw down on the helical screw.

Procedure: Static Locking

Interventions

Dynamic Rotational Locking PROCEDURE

Performed, as per the Synthes technique guide, using the 5mm hex flexible set screwdriver and then loosening the set screw by one-half turn of the screwdriver.

Dynamic rotational locking

Static Locking PROCEDURE

Performed by using the torque-limiting set screwdriver and locking the set screw down onto the helical screw to prevent dynamic sliding of the screw within the nail.

Static locking

Eligibility Criteria

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

You may qualify if:

• Patients \>18 years of age
• AO/OTA 31-A fractures who the surgeon deems eligible for treatment with a cephalomedullary nail
• Open and closed fractures
• Ambulatory prior to injury (with or without walking aides)
• Native (non-fractured, no implant) contralateral hip
• Willing and able to sign consent (substitute decision maker)

You may not qualify if:

• Contralateral hip fracture or hip arthroplasty
• Fracture not amenable to treatment with a cephalomedullary nail
• Non-ambulatory patient
• Fractures \>14 days (time of injury to OR)
• Bilateral pertrochanteric hip fractures
• Non-unions
• Pathologic fractures
• Periprosthetic fractures
• Patients with spinal injury
• Incarceration
• Pregnancy
• Limited life expectancy due to significant medical co-morbidities or medical contra-indications to surgery
• Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support).

Sponsors & Collaborators

• Fraser Orthopaedic Research Society: lead
• DePuy Synthes: collaborator

Study Sites (1)

Royal Columbian Hospital/Fraser Health Authority

New Westminster, British Columbia, V3L 3W7, Canada

RECRUITING

Related Publications (8)

• Kanis JA, Oden A, McCloskey EV, Johansson H, Wahl DA, Cooper C; IOF Working Group on Epidemiology and Quality of Life. A systematic review of hip fracture incidence and probability of fracture worldwide. Osteoporos Int. 2012 Sep;23(9):2239-56. doi: 10.1007/s00198-012-1964-3. Epub 2012 Mar 15.

  PMID: 22419370 BACKGROUND

• Zickel RE. A new fixation device for subtrochanteric fractures of the femur: a preliminary report. Clin Orthop Relat Res. 1967 Sep-Oct;54:115-23. No abstract available.

  PMID: 5589594 BACKGROUND

• Stapert JW, Geesing CL, Jacobs PB, de Wit RJ, Vierhout PA. First experience and complications with the long Gamma nail. J Trauma. 1993 Mar;34(3):394-400. doi: 10.1097/00005373-199303000-00015.

  PMID: 8483181 BACKGROUND

• Lecerf G, Fessy MH, Philippot R, Massin P, Giraud F, Flecher X, Girard J, Mertl P, Marchetti E, Stindel E. Femoral offset: anatomical concept, definition, assessment, implications for preoperative templating and hip arthroplasty. Orthop Traumatol Surg Res. 2009 May;95(3):210-9. doi: 10.1016/j.otsr.2009.03.010. Epub 2009 May 6.

  PMID: 19423418 BACKGROUND

• Paul O, Barker JU, Lane JM, Helfet DL, Lorich DG. Functional and radiographic outcomes of intertrochanteric hip fractures treated with calcar reduction, compression, and trochanteric entry nailing. J Orthop Trauma. 2012 Mar;26(3):148-54. doi: 10.1097/BOT.0b013e31821e3f8c.

  PMID: 21918483 BACKGROUND

• Yoo JH, Kim TY, Chang JD, Kwak YH, Kwon YS. Factors influencing functional outcomes in united intertrochanteric hip fractures: a negative effect of lag screw sliding. Orthopedics. 2014 Dec;37(12):e1101-7. doi: 10.3928/01477447-20141124-58.

  PMID: 25437085 BACKGROUND

• Gausden EB, Sin D, Levack AE, Wessel LE, Moloney G, Lane JM, Lorich DG. Gait Analysis After Intertrochanteric Hip Fracture: Does Shortening Result in Gait Impairment? J Orthop Trauma. 2018 Nov;32(11):554-558. doi: 10.1097/BOT.0000000000001283.

  PMID: 30239477 BACKGROUND

• Bishop JA, Palanca AA, Bellino MJ, Lowenberg DW. Assessment of compromised fracture healing. J Am Acad Orthop Surg. 2012 May;20(5):273-82. doi: 10.5435/JAAOS-20-05-273.

  PMID: 22553099 BACKGROUND

Study Officials

• Bertrand Perey, MD, FRCSC

  Royal Columbian Hospital/Fraser Health Authority

  PRINCIPAL INVESTIGATOR

• David Cinats, MD

  Orthopaedic Surgeon, Fraser Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyrsten Butterfield, BSc

CONTACT

604-553-3247; kyrsten.butterfield@fraserhealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Surgeons cannot be blinded to the treatment allocation of the surgical intervention due to having to perform the static or dynamic rotational lock. Participants will be blinded to the form of locking they receive. Research personnel completing the outcome measures will be blinded. Data analyst(s) and the radiographic reviewer(s) will be blinded to the treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Randomized trial design utilizing alternating treatment allocation to assign patients to treatment arms, treatment allocations will last for two months at a time.

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 20, 2021
• Study Start: May 17, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)