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Outcomes 8 Years After Minimal Invasive THA

Primary Purpose

Osteoarthritis, Hip

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
surgical approach
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Total Hip Arthroplasty, minimally invasive, Patient-relevant outcomes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Dresden, Orthopaedic Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

anterior (MI-A) surgical approach

anterolateral (MI-AL) surgical approach

direct lateral (DLA) surgical approach

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Physical function hip - Harris-Hip-Score (HHS)
Harris-Hip-Score (worst=0, best=100)

Secondary Outcome Measures

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

Full Information

First Posted
August 14, 2018
Last Updated
September 3, 2018
Sponsor
Technische Universität Dresden
Collaborators
Stryker Instruments
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1. Study Identification

Unique Protocol Identification Number
NCT03657953
Brief Title
Outcomes 8 Years After Minimal Invasive THA
Official Title
Patient-relevant Outcomes 8 Years After Minimally Invasive Total Hip Replacement - a Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2006 (Actual)
Primary Completion Date
June 30, 2015 (Actual)
Study Completion Date
September 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
Collaborators
Stryker Instruments

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
Keywords
Total Hip Arthroplasty, minimally invasive, Patient-relevant outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single-center prospective randomized study design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anterior (MI-A) surgical approach
Arm Type
Active Comparator
Arm Description
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.
Arm Title
anterolateral (MI-AL) surgical approach
Arm Type
Active Comparator
Arm Description
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.
Arm Title
direct lateral (DLA) surgical approach
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
surgical approach
Primary Outcome Measure Information:
Title
Physical function hip - Harris-Hip-Score (HHS)
Description
Harris-Hip-Score (worst=0, best=100)
Time Frame
change from baseline (preoperative) at 8 years after THA
Secondary Outcome Measure Information:
Title
Physical function hip - WOMAC
Description
WOMAC Total Score (worst=0, best=100)
Time Frame
change from baseline (preoperative) at 8 years after THA
Title
Satisfaction Level
Description
Satisfaction scale (worst=0, best=10)
Time Frame
at 8 years after THA
Title
health related Quality of life - Index
Description
EuroQol in 5 dimensions (EQ-5D) Index (worst=0, best=1)
Time Frame
change from baseline (preoperative) at 8 years after THA
Title
health related Quality of life - VAS
Description
EQ-Visual Analogue Scale (worst=0, best=100)
Time Frame
change from baseline (preoperative) at 8 years after THA
Title
Physical Activity
Description
University of California, Los Angeles (UCLA) Activity Scale (worst=1, best=10)
Time Frame
change from baseline (preoperative) at 8 years after THA
Title
Revision rate
Description
Revision rate using Kaplan-Meier-Survival Analysis
Time Frame
at 8 years after THA
Title
Physical Activity Performance Test: walking
Description
25-meter walking time
Time Frame
change from baseline (preoperative) at 8 years after THA
Title
Physical Activity Performance Test: stair climbing
Description
5-step walking time
Time Frame
change from baseline (preoperative) at 8 years after THA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maik Stiehler, MD
Organizational Affiliation
University Center for Orthopaedics and Trauma Surgery, University Hospital Carl Gustav
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Dresden, Orthopaedic Department
City
Dresden
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Outcomes 8 Years After Minimal Invasive THA

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