Outcomes 8 Years After Minimal Invasive THA

Not Applicable

Completed

• Conditions: Osteoarthritis, Hip

• Registration Number: NCT03657953
• Lead Sponsor: Technische Universität Dresden

Brief Summary

There exists only limited scientific evidence concerning medium- to long-term benefits concerning minimally invasive (MI) total hip arthroplasty (THA). The investigators examined in a randomized study design 157 patients 8 years after THA, which were performed via 3 different surgical approaches.

Detailed Description

In contrast to reported short-term advantages of minimally invasive (MI) total hip arthroplasty (THA) there exists only limited scientific evidence concerning medium- to long-term benefits.

The investigators therefore sought to answer the following questions: Is the functional medium-term outcome in THA patients with MI-anterior(MI-A) and MI-anterolateral (MI-AL) approach superior to those treated by direct lateral approach (DLA)? Is the level of life quality increased by MI-THA? Is patient satisfaction higher by MI-THA? Is the revision rate reduced by MI-THA?

Study Timeline

• Study Start: 2006-01-01
• Primary Completion: 2015-06-30
• Study Completion: 2015-09-30
• Study First Submitted: 2018-08-14
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-03
• Last Update Submitted: 2018-09-03
• Study First Posted: 2018-09-05
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

• clinical and radiologic signs of advanced hip joint Degeneration
• Patients from age 18 to 75

Exclusion Criteria

• osteoporosis and
• osteomalacia,
• preceding surgery or radiation therapy in the proximity of the affected hip joint,
• progressive neoplasia,
• preceding or manifest infection of the affected joint and its surrounding soft tissues,
• rheumatoid arthritis,
• hip dysplasia Hartofilakidis type 2 or 3,
• non-compliance,
• chronic neurological or psychiatric diseases,
• ongoing pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physical function hip - Harris-Hip-Score (HHS)	change from baseline (preoperative) at 8 years after THA	Harris-Hip-Score (worst=0, best=100)

Secondary Outcome Measures

Name	Time	Method
Physical function hip - WOMAC	change from baseline (preoperative) at 8 years after THA	WOMAC Total Score (worst=0, best=100)
Satisfaction Level	at 8 years after THA	Satisfaction scale (worst=0, best=10)
Physical Activity Performance Test: walking	change from baseline (preoperative) at 8 years after THA	25-meter walking time
Physical Activity Performance Test: stair climbing	change from baseline (preoperative) at 8 years after THA	5-step walking time
health related Quality of life - Index	change from baseline (preoperative) at 8 years after THA	EuroQol in 5 dimensions (EQ-5D) Index (worst=0, best=1)
health related Quality of life - VAS	change from baseline (preoperative) at 8 years after THA	EQ-Visual Analogue Scale (worst=0, best=100)
Physical Activity	change from baseline (preoperative) at 8 years after THA	University of California, Los Angeles (UCLA) Activity Scale (worst=1, best=10)
Revision rate	at 8 years after THA	Revision rate using Kaplan-Meier-Survival Analysis

Trial Locations

Locations (1)

University Hospital Dresden, Orthopaedic Department; 🇩🇪 Dresden, Germany