INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia

NCT02750072 | Completed DMC

• 1 other identifier: FHREB #: 2016-029
• Study Type: interventional
• Target: 248
• Locations: 2 countries
• Sites: 6

Brief Summary

This study will investigate the incidence and severity of anterior knee pain comparing two different approaches to tibial nail fixation; Infrapatellar versus percutaneous semi-extended suprapatellar incisions. Half the patients will be randomized to the gold standard infrapatellar approach with the other half being randomized to treatment with the percutaneous semi-extended suprapatellar approach.

Conditions

Tibial Fractures; Anterior Knee Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• VAS (visual analog scale) for pain on kneeling/ability to knee

  Participants assessment of their degree/level of pain on kneeling after performing the AKT (Aberdeen Kneeling Weight-Distribution Test) on a 10 cm visual analog scale

  12 months post treatment

Secondary Outcomes (8)

• AKT (Aberdeen Kneeling Weight-Distribution Test)

  4, 6, 12 and 24 months post treatment

• AST (Aberdeen Standing Weight-Distribution Test)

  4, 6, 12 and 24 months post treatment

• VAS (Visual Analog Scale) at rest, with walking and descending stairs

  4, 6, 12 and 24 months post treatment

• Lysholm Knee Scoring Scale

  4, 6, 12 and 24 months post treatment

• PKPM (Photographic knee pain map)

  4, 6,12 and 24 months post treatment

Study Arms (2)

Infrapatellar approach

ACTIVE COMPARATOR

Infrapatellar approach using the surgeon's incision of choice (i.e., patellar tendon split, tendon retraction medial, tendon retraction lateral).

Procedure: Infrapatellar Approach

Semi-extended suprapatellar approach

EXPERIMENTAL

Semi-extended suprapatellar approach using quadriceps split combined with purpose designed suprapatellar percutaneous instrumentation (patellofemoral protection sleeve).

Procedure: Suprapatellar Approach

Interventions

Infrapatellar Approach PROCEDURE

Infrapatellar approach using the surgeon's incision of choice (i.e. patellar tendon split, tendon retraction medial, tendon retraction lateral)

Infrapatellar approach

Suprapatellar Approach PROCEDURE

Semi-extended suprapatellar approach using quadriceps split combined with purpose designed percutaneous instrumentation

Semi-extended suprapatellar approach

Eligibility Criteria

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

You may qualify if:

• all extra-articular tibial fractures
• simple distal tibial intra-articular fractures amenable to IMN
• open and closed fractures
• bilateral tibiae
• willing and able to consent, follow protocol and attend follow-up visits
• able to read and understand English or have interpreter available

You may not qualify if:

• patients with contralateral femur and/or hip fracture requiring retrograde IMN
• patients with contralateral knee injuries that would impair their ability to kneel during the follow-up period
• associated knee injury
• previous symptomatic knee pathology
• ipsilateral injuries to the same limb that would interfere with rehab or outcome
• neurovascular injuries at the level of the knee requiring surgery
• open or closed fractures \> 14 days (times of injury to OR)
• non unions
• pathologic fractures
• periprosthetic fractures
• spinal injury
• non-ambulatory patients
• incarceration
• limited life expectancy due to significant medical co-morbidities or medical contra-indication to surgery (pregnancy)
• likely problems, in the judgment of the investigators, with maintaining follow-up

Sponsors & Collaborators

• Fraser Orthopaedic Research Society: lead

Study Sites (6)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Royal Columbian Hospital / Fraser Health Authority

New Westminster, British Columbia, V3L 3W7, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8L 8E7, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5C 1R6, Canada

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (26)

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MeSH Terms

Conditions

Tibial Fractures; Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Darius G Viskontas, MD, FRCSC

  Royal Columbian Hospital / Fraser Health Authority

  PRINCIPAL INVESTIGATOR

• Trevor B Stone, MD, FRCSC

  Royal Columbian Hospital / Fraser Health Authority

  PRINCIPAL INVESTIGATOR

• Alan Johnstone, Professor

  Aberdeen Royal Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 25, 2016
• Study Start: September 13, 2016
• Primary Completion: May 31, 2023
• Study Completion: October 12, 2023
• Last Updated: January 30, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); CA (5)