NCT02458144

Brief Summary

Aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. The investigation will compare the MIS (minimally invasive surgery) anterior approach with the MIS anterolateral approach to the hip.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

3.6 years

First QC Date

May 26, 2015

Last Update Submit

May 28, 2015

Conditions

Osteoarthritis of the Hip

Outcome Measures

Primary Outcomes (1)

  • MRI evaluation

    Cross-sectional area of gluteus medius and tensor fascia latae muscle (cm2)

    12 months after surgery

Secondary Outcomes (11)

  • Harris Hip Score

    12 months after surgery

  • Tendon defects of the hip abductors (cm) assessed by Ultrasound

    12 months after surgery

  • Gait analysis

    12 months after surgery

  • Serum trauma marker 1

    1 hour preop. to 48 hours postop.

  • Serum trauma marker 2

    1 hour preop. to 48 hours postop.

  • +6 more secondary outcomes

Study Arms (2)

MIS "anterior" group

OTHER

Total Hip Arthroplasty "anterior" surgical approach

Procedure: Total hip arthroplasty

MIS "anterolateral" group

OTHER

Total Hip Arthroplasty "anterolateral" surgical approach

Procedure: Total hip arthroplasty

Interventions

Total hip arthroplastyPROCEDURE

The minimally invasive anterior approach The patient is in supine position. The femoral neck is exposed in the interval between tensor fasciae latae, glutei medius and minimus muscles laterally, and sartorius and rectus femoris muscles medially. After osteotomy of the neck and extraction of the head the acetabulum is reamed to prepare for cup prosthesis. Following peritrochanteric capsulotomy the externally rotated, adducted and elevated femur is broached. The MIS anterolateral approach The MIS anterolateral technique is a modified Watson-Jones Approach. The patient is in supine position. This approach uses the intermuscular plane between the gluteus medius and the tensor fascia latae. After the anterior capsule is excised, a disc of the femoral neck is removed.

MIS "anterior" groupMIS "anterolateral" group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral, noninflammatory end-stage osteoarthritis of the hip
  • willingness and ability to cooperate in the required post-operative therapy
  • willingness and ability to provide written informed consent
  • age 50-80 years

You may not qualify if:

  • inflammatory arthropathies
  • prior hip surgery
  • prior infection of the hip
  • severe morbidity
  • severe osteoporosis
  • inability to tolerate general anesthesia
  • no contraindications to MRI e.g. pacemakers, claustrophobia
  • neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care
  • known alcohol or drug abuse
  • unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Reinhard Windhager, Chairman

    Medical University of Vienna

    STUDY CHAIR

Central Study Contacts

Christoph Stihsen, Registrar

CONTACT

00431 40400christoph.stihsen@meduniwien.ac.at

Bernd Kubista, Consultant

CONTACT

00431 40400bernd.kubista@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. univ.

Study Record Dates

First Submitted

May 26, 2015

First Posted

May 29, 2015

Study Start

January 1, 2013

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

AU(1)