Outcomes 8 Years After Minimal Invasive THA

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Hip
• Intervention / Treatment: Other: surgical approach

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 Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany, 01307
    • University Hospital Dresden, Orthopaedic Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: anterior (MI-A) surgical approach; The minimally invasive anterior surgical approach was carried out using a modified Smith-Petersen access as described by Bender et al. (Bender et al. 2009) with the patient in supine position.	Other: surgical approach
Active Comparator: anterolateral (MI-AL) surgical approach; For the minimally invasive anterolateral surgical approach, a modified Watson-Jones approach according to Röttinger (Rottinger et al. 2006) was applied with the patient in supine position.	Other: surgical approach
Active Comparator: direct lateral (DLA) surgical approach; The direct lateral surgical approach was performed according to the technique described by Hardinge et al. (Hardinge et al. 1982) with the patient positioned supine	Other: surgical approach

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: Stryker Instruments
• Investigators: Principal Investigator: Maik Stiehler, MD, University Center for Orthopaedics and Trauma Surgery, University Hospital Carl Gustav

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2006
• Primary Completion (Actual): June 30, 2015
• Study Completion (Actual): September 30, 2015

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: September 3, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Total Hip Arthroplasty; minimally invasive; Patient-relevant outcomes
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: THA MIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No