Outcomes 8 Years After Minimal Invasive THA

Osteoarthritis, Hip Clinical Trial

Official title:

Patient-relevant Outcomes 8 Years After Minimally Invasive Total Hip Replacement - a Randomized Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657953
• Other study ID #: THA MIC
• Status: Completed
• Phase: N/A
• Start date: January 1, 2006
• Est. completion date: September 30, 2015

Study information

• Verified date: September 2018
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: September 30, 2015
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Other:
• surgical approach

Locations

Country	Name	City	State
Germany	University Hospital Dresden, Orthopaedic Department	Dresden

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	Stryker Instruments

Country where clinical trial is conducted

Germany, 

Outcome

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