NCT03657953

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

9.5 years

First QC Date

August 14, 2018

Last Update Submit

September 3, 2018

Conditions

Osteoarthritis, Hip

Keywords

Total Hip Arthroplastyminimally invasivePatient-relevant outcomes

Outcome Measures

Primary Outcomes (1)

  • Physical function hip - Harris-Hip-Score (HHS)

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

    change from baseline (preoperative) at 8 years after THA

Secondary Outcomes (8)

  • Physical function hip - WOMAC

    change from baseline (preoperative) at 8 years after THA

  • Satisfaction Level

    at 8 years after THA

  • health related Quality of life - Index

    change from baseline (preoperative) at 8 years after THA

  • health related Quality of life - VAS

    change from baseline (preoperative) at 8 years after THA

  • Physical Activity

    change from baseline (preoperative) at 8 years after THA

  • +3 more secondary outcomes

Study Arms (3)

anterior (MI-A) surgical approach

ACTIVE COMPARATOR

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

anterolateral (MI-AL) surgical approach

ACTIVE COMPARATOR

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

direct lateral (DLA) surgical approach

ACTIVE COMPARATOR

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

surgical approachOTHER
anterior (MI-A) surgical approachanterolateral (MI-AL) surgical approachdirect lateral (DLA) surgical approach

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Dresden, Orthopaedic Department

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Maik Stiehler, MD

    University Center for Orthopaedics and Trauma Surgery, University Hospital Carl Gustav

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: single-center prospective randomized study design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2018

First Posted

September 5, 2018

Study Start

January 1, 2006

Primary Completion

June 30, 2015

Study Completion

September 30, 2015

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)