Intramedullary Nail Versus Hip Arthroplasty in Unstable Trochanteric Hip Fractures

NCT ID: NCT04868305

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2025-12-31

Brief Summary

A hip fracture is a large burden to the patient with increased mortality, pain and increased need for daily assistance. Trochanteric fractures of the femur (FTF) represents about 35% of the hip fractures. Today FTFs are mainly treated with internal fixation using sliding hips screws (SHS) or intramedullary nail (IMN), whilst hip arthroplasty (THA/HA) is rarely used. Despite advances in the design of the internal fixation implants there is a high failure rate, in particular in cases of FTFs classified as unstable fractures. Since the introduction of hip arthroplasty in femoral neck fractures there has been a reduction in complication rates, early mobilization and shorter hospital stays.

The primary objective of this project is to investigate if treatment with hip arthroplasty in unstable FTFs will increase the postoperative mobility, give a better general health outcome for the patient, better quality of life and reduce re-operation rate for the patients compared to those operated with the traditional IMN.

Detailed Description

Proximal femoral fractures also termed "hip" fractures are one of the most common fractures among adults over 50 years of age. With increase in life expectancy, the incidence of these fractures is also increasing. By 2040, the number of these fractures are expected to double in Norway. Trochanteric fractures of the femur (Fractura Trochanterica Femoris, FTF) represents about 35% of the hip fractures in Norway . There are many classification systems for FTFs, but The Orthopaedic Trauma Association (OTA) have adopted the system developed by the Arbeitsgemeinschaft Osteosynthese (AO ) group, and is the most commonly used in addition to the Evans Jensens classification.

The mean age of hip fracture patients is 82 years for women and 78 for men. The comorbidity in this patient group is high with large amount of dementia, sarcopenia and osteoporosis. The one-year mortality rate after a hip fractures is 20-35%. According to the Norwegian Hip Fracture Register 15 % of the hip fractures are unstable trochanteric fractures (AO 31A2.2-A3). The prognosis is poor, in particular for unstable (multi fragmented) fractures, with reported complications up to 35-51 %.

Substantial research has established better understanding and best practice guidelines to treat the femoral neck fractures, mostly with hip arthroplasty, however no superior method is established for the unstable trochanteric fractures. 'Getting It Right First Time' is important for these fragile patients, thus post-operative complications are associated with a large increase in the mortality.

Today, most of the FTFs are reduced and fixated with a sliding hip screw (SHS), although the use of intramedullary nails (IMN) is increasing. RCTs have shown better survival of IMN compared to SHS for the more distal FTFs and subtrochanteric fracture. Unstable FTFs (AO 31A2 - A3, EVJ III-V) have high reoperation rates (21-35%) when operated either with SHS or IMN. Unacceptable shortening, external rotation deformity of the limb and long time to recover/mobilization have been the problems with osteosynthesis.

The question is if hip arthroplasty can give a superior treatment outcome for patients suffering from unstable subtypes of trochanteric hip fractures compared to the traditional treatment with IMN. A randomized clinical trial is to be conducted comparing these two treatment methodologies.

Stavanger University Hospital (SUH) receives over 150 FTFs per year. About 1/3 of the FTFs are of unstable fracture morphology. The planned study is a randomized clinical trial. The randomization module will be provided by Klinisk forskningsenhet Midt-Norge (KlinForsk). Patients fulfilling the inclusion criteria will be randomized to one of two treatment groups, IMN versus hip arthroplasty.

Included patients will be treated in accordance to a local operation protocol:

Intramedullary nails will be operated by a resident orthopedic surgeon with at least 2 years' experience in fracture surgery or a consultant orthopedic surgeon (there must always be a consultant orthopedic surgeon present in the surgical team). A long IMN must always be utilized. Anatomical reposition or positive anterior and medial cortical support should be strived to be achieved. If a large antero- or posteromedial fragment is present one should consider an additional cerclage to fix the fragment.

Arthroplasty will be operated by a resident orthopedic surgeon with at least 2 years' experience with hip arthroplasty surgery or by a consultant orthopedic surgeon subspecialized in arthroplasty surgery, with competency within revision or difficult primary hip arthroplasty surgery (there must always be a consultant orthopedic surgeon subspecialized in arthroplasty surgery present in the surgical team). Posterior surgical approach will be used. If a cup is to be utilized it must be a cemented dual-mobility cup.

The patients will have follow-up appointments at 2-, 6 and 12 months postoperative. Following data will be collected:

• Patient reported outcome measures (HOOS and EQ5D)
• Timed up and go test
• Trendelenburg test
• Clinical leg length discrepancy
• Radiological assessment from hip x-rays (AP and lateral)

Conditions

Hip Injuries and Disorders; Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intramedullary nail

Intramedullary nail with proximal lagscrew and distal locking screw(s)

Group Type: ACTIVE_COMPARATOR

Intramedullary nail

Intervention Type: PROCEDURE

Intertan nail (Smith & Nephew)* or Gamma 3 nail (Stryker)*

• All of the above-mentioned products are subjects to change into an equivalent product

Hip arthroplasty

Hemiarthroplasty (HA) or Total hip arthroplasty (THA). A cemented dual-mobility cup will be utilized in THA. Addition of cerclage/trochanter claw plate to fixate trochanter major will be used when suitable.

Group Type: ACTIVE_COMPARATOR

Hip arthroplasty

Intervention Type: PROCEDURE

Total hip arthroplasty:

• Cemented: Lubinus (Link)*, Exeter (Stryker)*
• Uncemented: Restoration Modular (Stryker)*
• Cup: Cemented Avantage dual mobility cup (Zimmer Biomet)*

Hemiarthroplasty:

• Cemented: Lubinus (Link)*, Exeter (Stryker)*
• Uncemented: Restoration Modular (Stryker)*

• All of the above-mentioned products are subjects to change into an equivalent product

Interventions

Intramedullary nail

Intertan nail (Smith & Nephew)* or Gamma 3 nail (Stryker)*

• All of the above-mentioned products are subjects to change into an equivalent product

Intervention Type: PROCEDURE

Hip arthroplasty

Total hip arthroplasty:

• Cemented: Lubinus (Link)*, Exeter (Stryker)*
• Uncemented: Restoration Modular (Stryker)*
• Cup: Cemented Avantage dual mobility cup (Zimmer Biomet)*

Hemiarthroplasty:

• Cemented: Lubinus (Link)*, Exeter (Stryker)*
• Uncemented: Restoration Modular (Stryker)*

• All of the above-mentioned products are subjects to change into an equivalent product

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 65 years
• American Society of Anesthesiology Score (ASA) < 4
• Ambulant with or without aid (preinjury)
• Radiological verified unstable trochanteric hip fracture (AO 31A2.2 - 3.3)
• Written consent obtained by patient or his/her next of kin

Exclusion Criteria

• Previous hip surgery on ipsilateral or contralateral side
• Non-ambulant preinjury
• Patient not living in the area of hospital care

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Stavanger HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ane Djuv, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Jan-Erik Gjertsen, MD., PhD

Role: STUDY_CHAIR

Haukeland University Hospital

Locations

Stavanger University Hospital

Stavanger, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Thomas Abel Woldeyesus, MD

Role: CONTACT

thomas.abel.woldeyesus@sus.no

+4751513488

Ane Djuv, MD., PhD

Role: CONTACT

ane.djuv@sus.no

+4751518284

Facility Contacts

Thomas Woldeyesus, MD

Role: primary

Other Identifiers

140120V1

Identifier Type: -

Identifier Source: org_study_id