NCT01506024

Brief Summary

The aim of the present study is to explore the most efficient surgical approach in total hip replacement in short and long term when concerning strength, functionality and postoperative complications. The objective is to register muscular strength, hip joint functionality/mobilisation and complications after total hip arthroplasty (THA) performed by the direct lateral approach (DLA), the posterior approach (PA) and the anterior approach (AA). The latter is a modified Smith-Petersen approach which follows the principles of minimally invasive surgery (MIS). The primary working hypothesis is that due to a minimal dissection and reduced trauma in the muscles, patients will tolerate early hospital discharge better after the AA than the PA and the DLA. Patients in the AA group are also thought to be more active and maintain muscular strength and hip joint functionality/mobilisation better than patients in the lateral group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration 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

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

2.6 years

First QC Date

December 9, 2011

Last Update Submit

November 14, 2018

Conditions

Hip Osteoarthritis

Keywords

Arthroplasty, Replacement, HipSurgical Procedures, OperativeSurgical Procedures, Minimally Invasive

Outcome Measures

Primary Outcomes (1)

  • Muscle strength

    Measured by 1 repetition maximum (1 RM)

    3 months postoperatively

Secondary Outcomes (2)

  • Hip joint functionality and mobility

    3 months postoperatively

  • activity level

    6 subsequent days postoperatively

Study Arms (3)

THA Direct lateral

ACTIVE COMPARATOR

Total hip arthroplasty (THA) carried out by direct lateral approach (DLA)

Procedure: Total hip arthroplasty direct lateral approach

THA Posterior

EXPERIMENTAL

Total hip arthroplasty (THA) carried out by posterior approach (DLA)

Procedure: Total hip arthroplasty posterior approach

THA Anterior

EXPERIMENTAL

Total hip arthroplasty (THA) carried out by anterior approach (DLA)

Procedure: Total hip arthroplasty, anterior approach

Interventions

Total hip arthroplasty direct lateral approachPROCEDURE
Also known as: Total hip replacement, THA
THA Direct lateral
Total hip arthroplasty posterior approachPROCEDURE
Also known as: Total hip replacement, THA
THA Posterior
Total hip arthroplasty, anterior approachPROCEDURE
Also known as: Total hip replacement, THA
THA Anterior

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for THA
  • Diagnosis of primary osteoarthritis as the main cause for elective THA
  • American Society of Anesthesiologists (ASA) score I, II, and stable III

You may not qualify if:

  • Musculoskeletal diseases
  • Current heart/pulmonary- or malignant diseases likely to influence the physical testing performance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs Hospital

Trondheim, Norway

Location

Related Publications (2)

  • Winther SB, Husby VS, Foss OA, Wik TS, Svenningsen S, Engdal M, Haugan K, Husby OS. Muscular strength after total hip arthroplasty. A prospective comparison of 3 surgical approaches. Acta Orthop. 2016 Feb;87(1):22-8. doi: 10.3109/17453674.2015.1068032. Epub 2015 Aug 27.

    PMID: 26141371RESULT

  • Winther SB, Foss OA, Husby OS, Wik TS, Klaksvik J, Husby VS. Muscular strength and function after total hip arthroplasty performed with three different surgical approaches: one-year follow-up study. Hip Int. 2019 Jul;29(4):405-411. doi: 10.1177/1120700018810673. Epub 2018 Nov 13.

    PMID: 30421633RESULT

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, HipTacrine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis ImplantationAminoacridinesAcridinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Lars Jacob Stovner, prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2011

First Posted

January 9, 2012

Study Start

September 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

November 16, 2018

Record last verified: 2018-11

Locations

NO(1)