Intramedullary Nail Versus Hip Arthroplasty in Unstable Trochanteric Hip Fractures

NCT04868305 | Recruiting

• 1 other identifier: 140120V1
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Injuries and Disorders; Hip Fractures

Keywords

Trochanteric hip fracture; Unstable trochanteric hip fractures

Outcome Measures

Primary Outcomes (2)

• Patient Reported Outcome Measure (PROM)

  Hip disability and Osteoarthritis Outcome Score (HOOS). "HOOS is developed as an instrument to assess the patients' opinion about their hip and associated problems. HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The result can be plotted as an outcome profile. * Above information about HOOS is copied from the authors of www.KOOS.nu * Change in HOOS score will be observed from 2-, 6- and 12 months.

  Collected at 2, 6 and 12 months from primary surgery

• Patient Reported Outcome Measure (PROM)

  EuroQol EQ-5D. "The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement." Change in EQ-5D score will be observed from 2-, 6- and 12 months.

  Collected from 2 to 12 months from primary surgery

Secondary Outcomes (20)

• Mortality

  2, 6 and 12 months from primary surgery

• Complications related to prosthesis

  Collected from 2 to 12 months from primary surgery

• Complications related to osteosynthesis

  Collected from 2 to 12 months from primary surgery

• Somatic postoperative complications

  Collected from 2 to 12 months from primary surgery

• Reoperation rate

  Collected at 2, 6 and 12 months from primary surgery

Study Arms (2)

Intramedullary nail

ACTIVE COMPARATOR

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

Procedure: Intramedullary nail

Hip arthroplasty

ACTIVE COMPARATOR

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.

Procedure: Hip arthroplasty

Interventions

Intramedullary nail PROCEDURE

Intertan nail (Smith \& Nephew)\* or Gamma 3 nail (Stryker)\* \* All of the above-mentioned products are subjects to change into an equivalent product

Intramedullary nail

Hip arthroplasty 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

Hip arthroplasty

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Helse Stavanger HF: lead

Study Sites (1)

Stavanger University Hospital

Stavanger, Norway

RECRUITING

MeSH Terms

Conditions

Hip Injuries; Disease; Hip Fractures

Interventions

Fracture Fixation, Intramedullary; Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Femoral Fractures; Fractures, Bone; Leg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation, Internal; Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative; Arthroplasty, Replacement; Arthroplasty; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Ane Djuv, MD., PhD

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

• Jan-Erik Gjertsen, MD., PhD

  Haukeland University Hospital

  STUDY CHAIR

Central Study Contacts

Thomas Abel Woldeyesus, MD

CONTACT

+4751513488; thomas.abel.woldeyesus@sus.no

Ane Djuv, MD., PhD

CONTACT

+4751518284; ane.djuv@sus.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Patients with an identified unstable trochanteric hip fracture (AO 31A2.2-3.3) who has fulfilled inclusion criteria and given their consent will be randomized into one of two treatments; Intramedullary nail versus hip arthroplasty

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 30, 2021
• Study Start: October 12, 2021
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)