CClinicalTrials.gg
CompletedNCT03657953Updated Sep 5, 2018

Outcomes 8 Years After Minimal Invasive THA

An interventional study of surgical approach in Osteoarthritis, Hip, sponsored by Technische Universität Dresden. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Technische Universität Dresden · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 12 years 7 months after the study started (first participant enrolled Jan 2006, registered Aug 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
157
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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?

02

Conditions studied

  • Osteoarthritis, Hip

Browse trials for

Keywords

  • Total Hip Arthroplasty
  • minimally invasive
  • Patient-relevant outcomes
03

In context

Osteoarthritis, Hip

628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.

This study's enrollment of 157 is above the median of 90 across 450 interventional studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Technische Universität Dresden is the lead sponsor of 237 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
157 participants (actual)

Study arms

  • 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

Interventions

  • Othersurgical approach
06

What researchers measure

Primary outcomes

  1. Physical function hip - Harris-Hip-Score (HHS)

    Harris-Hip-Score (worst=0, best=100)

    Time frame: change from baseline (preoperative) at 8 years after THA

Secondary outcomes

  1. Physical function hip - WOMAC

    WOMAC Total Score (worst=0, best=100)

    Time frame: change from baseline (preoperative) at 8 years after THA

  2. Satisfaction Level

    Satisfaction scale (worst=0, best=10)

    Time frame: at 8 years after THA

  3. health related Quality of life - Index

    EuroQol in 5 dimensions (EQ-5D) Index (worst=0, best=1)

    Time frame: change from baseline (preoperative) at 8 years after THA

  4. health related Quality of life - VAS

    EQ-Visual Analogue Scale (worst=0, best=100)

    Time frame: change from baseline (preoperative) at 8 years after THA

  5. Physical Activity

    University of California, Los Angeles (UCLA) Activity Scale (worst=1, best=10)

    Time frame: change from baseline (preoperative) at 8 years after THA

  6. Revision rate

    Revision rate using Kaplan-Meier-Survival Analysis

    Time frame: at 8 years after THA

  7. Physical Activity Performance Test: walking

    25-meter walking time

    Time frame: change from baseline (preoperative) at 8 years after THA

  8. Physical Activity Performance Test: stair climbing

    5-step walking time

    Time frame: change from baseline (preoperative) at 8 years after THA

07

Study locations

1 site
  • University Hospital Dresden, Orthopaedic Department
    Dresden, 01307, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03657953
Lead sponsor
Technische Universität Dresden
Collaborators
Stryker Instruments
Responsible party
Sponsor
First posted
Sep 5, 2018
Start date
Jan 1, 2006
Primary completion
Jun 30, 2015
Completion
Sep 30, 2015
Last update
Sep 5, 2018

Study contacts

Maik Stiehler, MD
principal investigator · University Center for Orthopaedics and Trauma Surgery, University Hospital Carl Gustav

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion