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Prospective comparison of the anterior and lateral approach in hemiarthroplasty for hip fractures


- candidate number26889
- NTR NumberNTR6238
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-mrt-2017
- Secondary IDs16-059 
- Public TitleProspective comparison of the anterior and lateral approach in hemiarthroplasty for hip fractures
- Scientific TitleProspective comparison of the anterior and lateral approach in hemiarthroplasty for hip fractures
- ACRONYM
- hypothesisBackground: The Direct Anterior Approach (DAA) is an alternative approach to the currently most used Lateral Approach (LA) for hip replacement in femoral neck fracture patients. Compared to the LA, the DAA minimalizes soft tissue damage. Sparing muscle tissue may facilitate early and improved postoperative mobility. It may also be associated with fewer complications, increased quality of life and lower mortality. The aim of this study is to compare postoperative complications, hip function and patient mobility after hemiarthroplasty via the anterior or lateral approach following a femoral neck fracture. Methods/design: 138 elderly patients with a dislocated femoral neck fracture will be operated using either the direct anterior approach or the lateral approach for a hemiarthroplasty in a single centre, prospective, comparative cohort study. The choice of surgical approach will depend on the expertise of the surgeon and the duty rotary system of the hospital. The primary outcome of this study will be functionality of the hip measured with the Harris Hip Score at 12 months after surgery during routine outpatient check-ups. Secondary outcomes include surgical and non-surgical complication rates, admission time, postoperative pain, rehabilitation time, performance in activities of daily living using the Katz-ADL index, health-related quality of life measured with the EQ-5D questionnaire, cognitive function and balance.
Discussion: Many approaches are known for hip replacement arthroplasty in trauma patients with little consensus on the preferred method. Identifying a superior approach that leads to a better and quicker recovery could improve patient independency and quality of life and reduce rehabilitation costs, morbidity and mortality rates. The study design will reflect daily clinical practice and therefor present an accurate depiction of true clinical outcomes.
- Healt Condition(s) or Problem(s) studiedHip fractures, Hemiarthroplasty
- Inclusion criteriaAll consecutive patients of 70 years or older admitted to the study hospital with an X-ray proven dislocated femoral neck fracture (AO type 31 B1-B3) that are considered able to rehabilitate will be included in this study.
- Exclusion criteria- Other concomitant traumatic comorbidities restricting long-term rehabilitation.
- Patients incapable of physical therapy for rehabilitation by severe cognitive impairment.
- Patients incapable of physical therapy for rehabilitation by pre-existing physical restrictions.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jan-2017
- planned closingdate1-jan-2019
- Target number of participants138
- Interventionseither the direct anterior approach or the lateral approach for a hemiarthroplasty in a single centre, prospective, comparative cohort study. The choice of surgical approach will depend on the expertise of the surgeon and the duty rotary system of the hospital.
- Primary outcomeThe primary outcome of this study is the long-term functionality of the hip fracture patient in daily life using the Harris Hip Score (HHS) after surgery.
- Secondary outcomeClinical outcomes
Surgical parameters: operation-time (skin-to-skin), total blood loss.
Surgical complications (postoperative bleeding , hematoma formation, implant failure, implant dislocation , implant luxation, femoral head necrosis, periprosthetic fractures , superficial wound infection , deep wound (prosthesis) infection , nerve damage ).
Cognitive status measured with the 6CIT-score[13, 14] before surgery and at 6 weeks, 3 months and 12 months after surgery, and DOS scores during admission[15].
Duration of hospital stay, cause of delayed discharge (considered later than 72 hours after surgery), discharge destination and duration of rehabilitation.
Readmission and operative revision.
1-year mortality .
Non-surgical complications up to one year after surgery (delirium , anaemia , cardiac complications (decompensation and ischaemia, CVA, pressure sores , electrolyte disturbances, pulmonary embolism , pneumonia , renal failure, sepsis , deep venous thrombosis and urinary tract infections ).
The functionality and balance through a series of physiotherapeutic tests (SPPB, TUG, FAC) at 6 weeks, 3 months and 12 months after surgery.
Pain measured using a visual analogue scale (VAS) during admission and at 6 weeks, 3 months and 12 months after surgery.
Patient reported performance in activities of daily living using the Katz-ADL index[16] at 6 weeks, 3 months and 12 months after surgery.
Health-related quality of life using the EQ-5D questionnaire[17, 18] at 6 weeks, 3 months and 12 months after surgery.
- TimepointsAdmission, 6 weeks after surgery, 3 months after surgery and 12 months after surgery
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Nicky Nibbeling
- CONTACT for SCIENTIFIC QUERIES Max P.L. van der Sijp
- Sponsor/Initiator Haaglanden Medical Center, The Hague
- Funding
(Source(s) of Monetary or Material Support)
Haaglanden Medical Center, The Hague
- Publications
- Brief summaryBackground: The Direct Anterior Approach (DAA) is an alternative approach to the currently most used Lateral Approach (LA) for hip replacement in femoral neck fracture patients. Compared to the LA, the DAA minimalizes soft tissue damage. Sparing muscle tissue may facilitate early and improved postoperative mobility. It may also be associated with fewer complications, increased quality of life and lower mortality. The aim of this study is to compare postoperative complications, hip function and patient mobility after hemiarthroplasty via the anterior or lateral approach following a femoral neck fracture.
Methods/design: 138 elderly patients with a dislocated femoral neck fracture will be operated using either the direct anterior approach or the lateral approach for a hemiarthroplasty in a single centre, prospective, comparative cohort study. The choice of surgical approach will depend on the expertise of the surgeon and the duty rotary system of the hospital. The primary outcome of this study will be functionality of the hip measured with the Harris Hip Score at 12 months after surgery during routine outpatient check-ups. Secondary outcomes include surgical and non-surgical complication rates, admission time, postoperative pain, rehabilitation time, performance in activities of daily living using the Katz-ADL index, health-related quality of life measured with the EQ-5D questionnaire, cognitive function and balance.
Discussion: Many approaches are known for hip replacement arthroplasty in trauma patients with little consensus on the preferred method. Identifying a superior approach that leads to a better and quicker recovery could improve patient independency and quality of life and reduce rehabilitation costs, morbidity and mortality rates. The study design will reflect daily clinical practice and therefor present an accurate depiction of true clinical outcomes.
- Main changes (audit trail)
- RECORD13-mrt-2017 - 24-apr-2017


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