NCT01616667

Brief Summary

The aim of this study is to investigate the clinical outcome of the two different, but widely used, surgical approaches (Posterior approach and Lateral approach) of primary total hip arthroplasty in patients diagnosed with osteoarthritis. This study is divided into one main study and two sub-studies. The main study investigates the patient-reported outcome measures (questionnaire) within the first year post surgery. The two sub-studies investigate; i) the level of physical function and pain within the first 3 month after surgery, and ii) investigate the potential difference the two approaches have on gait-patterns and maximal isometric hip-muscle-strength, within the first year after surgery. Both approaches are described with potential drawbacks. Posterior approach has a higher risk of dislocation of the prostheses and revision due to dislocation compared with Lateral approach. Contrary, Lateral approach is described with the potential drawbacks of pain, lower physical function, gait abnormalities and muscle weakness, leading to less satisfied patients. However, according to a Cochrane analysis from 2004 concludes, more investigation is needed to determine the extent of differences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2012

Typical duration for phase_2

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

May 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

3 years

First QC Date

May 30, 2012

Last Update Submit

June 3, 2015

Conditions

Unilateral Primary Osteoarthritis of Hip

Keywords

Controlled Clinical TrialOperative Surgical ProceduresTreatment OutcomePain MeasurementQuality of LifeQuestionnaires/standardsActivities of Daily LivingBiomechanicsGait*Hip Joint/physiology*Hip Joint/surgery*Recovery of Function/physiology

Outcome Measures

Primary Outcomes (1)

  • Hip Disability and Osteoarthritis Outcome Score (HOOS)-Physical Function Short form(HOOS-PS), 12 month

    Primary study: Hip Disability and Osteoarthritis Outcome Score (HOOS) includes five subscales: 1)Pain 2) Other symptoms 3) Activities of daily living(ADL) 4) Sport and recreation function and 5) Hip related quality of life. HOOS-Physical Function Short form (HOOS-PS) is an aggregation and shortening of the two original subscales of HOOS-ADL and Sport and Recreation. HOOS-PS is a validated instrument. HOOS has been translated to Danish. We will use HOOS-PS as primary outcome.

    Endpoint 12 month

Secondary Outcomes (18)

  • Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 12 month

    Baseline, 3 month, 6 month and endpoint 12 month

  • Hip Disability and Osteoarthritis Outcome Score (HOOS)-Hip related quality of life, 12 month

    Baseline, 3 month, 6 month and endpoint 12 month

  • University of California Los Angeles activity score (UCLA), 12 month

    Baseline, 3 month, 6 month and endpoint 12 month

  • EQ-5D self-rated health index -and EQ VAS scores, 12 month

    Baseline, 3 month, 6 month and endpoint 12 month

  • The 20 meter walk-test (20MeWa)

    Baseline, 3 days, 21 days and endpoint 3 month

  • +13 more secondary outcomes

Study Arms (2)

Modified direct lateral approach

ACTIVE COMPARATOR

The patients included is operated with a total hip arthroplasty using a modified direct lateral approach

Procedure: Total hip arthroplasty

Posterior approach

ACTIVE COMPARATOR

The patients included is operated with a total hip arthroplasty using posterior approach

Procedure: Total hip arthroplasty

Interventions

Total hip arthroplastyPROCEDURE

The patients included is operated with a total hip arthroplasty due to primary osteoarthritis

Modified direct lateral approachPosterior approach

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 45-70 years, both included.
  • Patients schedule for primary cementless total hip arthroplasty.
  • Endstage hip osteoarthritis(OA) or minor dysplasia of the hip(CE-angle \> 20 degrees).

You may not qualify if:

  • more major joint (hip or knee) than the current hip affected with OA, with expected joint replacement surgery within a year.
  • Prior joint replacement surgery on any major joint (hip, knee) in lower limb.
  • BMI above 35.
  • Any physical disability that prevents patients from walking 20 meters without aid.
  • The patients is not suitable for standard cementless prosthetic components.
  • Any neurological disease (ex. cerebral thrombosis, Parkinson) compromising the walking ability.
  • Any severe medical condition compromising walking ability (ex. chronic heart failure, chronic obstructive pulmonary disease).
  • Severe dementia.
  • Inability to read and understand Danish writing and oral instructions.
  • Do not want to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000 C, Denmark

Location

Related Publications (2)

  • Rosenlund S, Broeng L, Overgaard S, Jensen C, Holsgaard-Larsen A. The efficacy of modified direct lateral versus posterior approach on gait function and hip muscle strength after primary total hip arthroplasty at 12months follow-up. An explorative randomised controlled trial. Clin Biomech (Bristol). 2016 Nov;39:91-99. doi: 10.1016/j.clinbiomech.2016.09.011. Epub 2016 Sep 30.

    PMID: 27721093DERIVED

  • Rosenlund S, Broeng L, Jensen C, Holsgaard-Larsen A, Overgaard S. The effect of posterior and lateral approach on patient-reported outcome measures and physical function in patients with osteoarthritis, undergoing total hip replacement: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2014 Oct 27;15:354. doi: 10.1186/1471-2474-15-354.

    PMID: 25345483DERIVED

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Signe Rosenlund, MD

    Odense University Hospital and University of Southern Denmark

    PRINCIPAL INVESTIGATOR

  • Søren Overgaard, MD, Professor

    Odense University Hospital and University of Southern Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, ph.d.-student

Study Record Dates

First Submitted

May 30, 2012

First Posted

June 12, 2012

Study Start

May 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations

DK(1)