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Comparing Two Patient Positions During Surgery for Thighbone Fractures: Which Position Helps Bone Heal Straighter

ROMANOFF - Rotational Malalignment in Nailing of Femur Fractures - A Comparative Randomized Study between Supine and Lateral Position

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090344
Enrollment
80
Registered
2025-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S723- Fracture of shaft of femur Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Lateral position nailing: Nailing of femur Fractures which will be done in lateral position on radiolucent table Control Intervention1: Supine position nailing: Nailing of femur Fractur

Sponsors

Christian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult aged 18 years of age or older presenting to casualty or OPD Diaphyseal femur fractures A0 32 appropriate for antegrade nail fixation Ability to obtain perioperative imaging (CT scans) Provision of informed consent Enrolled within 3 weeks of femoral shaft fixation Open fractures Gustilo Anderson type 1, 2, 3A Bilateral femur fractures

Exclusion criteria

Exclusion criteria: Ipsilateral neck of femur fractures Distal femur shaft fractures amenable to retrograde nail fixation Ipsilateral tibia fractures Ipsilateral acetabular fractures Periprosthetic fractures Pathological fractures Open fractures Gustilo Anderson type 3B, 3C Inability to be positioned in lateral decubitus because of a concomitant injury Contraindications to CT imaging including impaired kidney/liver function, or lack of timely availability Pregnancy (due to decubitus positioning)

Design outcomes

Primary

MeasureTime frame
To compare post-operative rotational alignment of operative limb with CT scan axial images after surgery using 2 positions Timepoint: 1st postoperative day—

Secondary

MeasureTime frame
Pain score at 6 weeks, 3 months & 6 months using VAS score Functional score by a LEFS (Lower Extremity Functional Scale) score at 6 weeks, 3 months & 6 months. Knee ROM at 6 weeks, 3 months & 6 months. Time to union Operative time between two groups Number of open reductions Intraoperative complications such as perineal skin & soft tissue compromise Timepoint: 6 weeks, 3 months & 6 months—

Countries

India

Contacts

Public ContactGokulprasath S

Christian medical College vellore

gokulprasath92@gmail.com9994390198

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026