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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22528
Enrollment
138
Registered
2017-03-13
Start date
2017-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

hip fracture

Interventions

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 experti

Sponsors

Funding for this study was provided by the Science Fund of the foundation HMC department of surgery, HMC, The Hague, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All 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

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.

Design outcomes

Primary

MeasureTime frame
The 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

MeasureTime frame
Clinical 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.

Contacts

Public ContactNicky Nibbeling

Hogeschool van Amsterdam

n.nibbeling@hva.nltel: 0621156503

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)