Full Versus Partial Repairing of Soft Tissue Surrounding the Hip in Arthroplasty for Femoral Neck Fractures

• Conditions: Femoral Neck Fracture
• Interventions: Procedure: Full Repairng of soft tissue surrounding the hip; Procedure: Partial Repairng of soft tissue surrounding the hip

• Registration Number: NCT02897440
• Lead Sponsor: First Hospitals affiliated to the China PLA General Hospital

Brief Summary

A prospective cohort study to compare full repairing and partial repairing of soft tissue surrounding the hip joint in anteriorolateral approaching arthroplasty concerning hip function. Patients admitted with a femoral neck fracture operated with a hip arthroplasty through an anteriorolateral approach were screened for inclusion. Patients with altered mental status SPMSQ \<7, pathological fractures, non-walkers were excluded.

Detailed Description

Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 2 months postoperatively by clinical examination. Sample size were estimated to 15 patients in each group. Primary outcome variables were trendelenburg test, abductor strength measured with dynamometry. Secondary outcome variables were WOMAC, EQ-5D, and VAS scores.

Study Timeline

• Study First Submitted: 2016-08-24
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-07
• Last Update Submitted: 2016-09-07
• Study First Posted: 2016-09-13
• Last Update Posted: 2016-09-13
• Study Start: 2016-10
• Primary Completion: 2017-11
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Displaced femoral neck fracture
• Walker
• Hemiarthroplasty or Total Hip Arthroplasty
• Preiffer test >7/10

Exclusion Criteria

• Pathological fracture
• Non-walker
• Pfeiffer test <7/10 indicating mental alteration

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Full Repairing of soft tissue surrounding the hip	Full Repairng of soft tissue surrounding the hip	Full repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting
Partial Repairing of soft tissue surrounding the hip	Partial Repairng of soft tissue surrounding the hip	Partial repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting

Primary Outcome Measures

Name	Time	Method
Trendelenburg Test	At 4 week postoperatively	30 seconds standing on the operated leg
Abductor strength	At 4 week postoperatively	Dynamometry

Secondary Outcome Measures

Name	Time	Method
Pain (Visual analouge scale)	At 2, 4, 6 weeks and 12 months postoperatively	Visual analouge scale (VAS): At rest and during activity
Quality of life (EQ-5D)	At 2, 4, 6 weeks and 12 months postoperatively	EQ-5D
WOMAC	At 2, 4, 6 weeks and 12 months postoperatively	An established hip score