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Outcomes 8 Years After Minimal Invasive THA

T

Technische Universität Dresden

Status

Completed

Conditions

Osteoarthritis, Hip

Treatments

Other: surgical approach

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03657953
THA MIC

Details and patient eligibility

About

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.

Full 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?

Enrollment

157 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

157 participants in 3 patient groups

anterior (MI-A) surgical approach
Active Comparator group
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.
Treatment:
Other: surgical approach
anterolateral (MI-AL) surgical approach
Active Comparator group
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.
Treatment:
Other: surgical approach
direct lateral (DLA) surgical approach
Active Comparator group
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
Treatment:
Other: surgical approach

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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