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Surgical treatment of osteoporotic hip fractures

Prospective, randomized, clinical study of single screw cephalomedullary nailing vs integrated dual interlocking screw fixation for unstable (AO/OTA A21-3) intertrochanteric fractures in patients >70 years old

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15588442
Enrollment
200
Registered
2022-04-19
Start date
2022-05-01
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Interthcohanteric hip fractures in the elderly Injury, Occupational Diseases, Poisoning Fracture of neck of femur

Interventions

Patients will be randomised via a computerised generation system managed by the Orthopaedic Department of Patras University Hospital allocating patients to two study groups of equal weights using rand

Sponsors

General University Hospital of Patras
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Traumatic closed intertrochanteric femur fracture (A2 AO/OTA) 2. Patients aged over 70 years 3. Presentation to hospital within 7 days of injury 4. No concomitant injuries or prior operations to the unaffected hip

Exclusion criteria

Exclusion criteria: 1. Patients with concomitant injuries affecting treatment and rehabilitation of the affected limb 2. Patients with associated neurovascular injuries requiring immediate surgery 3. Patients with limited Greek proficiency including family members 4. Patients where consent is refused 5. Patients with severe dementia, non-ambulated and with severe associated diseases prohibiting operative intevention

Design outcomes

Primary

MeasureTime frame
1. Radiological measurements (cut-out, varus displacement, loss of reduction, malunion, nonunion) at the 24 weeks follow-up evaluation 2. Functional status assessed using patient-reported disease-specific scores (Harris Hip score HHS and Oxford hip score-OHS) at 6, 12 and 24 weeks follow up

Secondary

MeasureTime frame
1. Perioperative and intraoperative surgical data (delay for surgery, age-adjusted Carlson Comorbidity Index, operation time, fluoroscopy time and dosage, blood loss, length of hospital stay, prescription of pain-killers, osteoporosis assessment using postoperative DEXA of the unaffected hip, union time and intraoperative surgeon related complications, including lag screw malposition, propagation of the fracture, non-anatomical reduction, varus/valgus deformity, rotational deformity and tip-apex distance (TAD) using postoperative CT of the pelvis). All measurements are done during hospital stay except for union time which usually happens at 8-10 weeks post-surgery 2. Pain level measured using the visual analogue scale (VAS) Pain Score in the perioperative period and at 6, 12 and 24 weeks postoperatively 3. Patient-reported general health status measured using the SF-36 form, the EQ-5D-3L Questionnaire, the SARC-F Index and the Elderly Mobility Scale (EMS) prior to surgery and at 6-, 12- and 24-weeks post-surgery

Countries

Greece

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 10, 2026