NCT01229293

Brief Summary

This study is conducted at Odense University Hospital(OUH) in collaboration with Institute of Clinical Biomechanics and Sport Science, University of Southern Denmark and Clinical Institute, University of Southern Denmark Aim: To evaluate the effect of implant design on postoperative total leg muscle function recovery and gait in hip replacement patients. Design: A prospective randomized controlled clinical trial where patients are randomized into (A) total hip arthroplasty surgery (THA) or (B) resurfacing total hip replacement surgery (RTHA). Pre-surgery assessment and follow-up will be conducted at 8, 26 and 52 wks post-surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2007

Longer than P75 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

February 1, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

September 25, 2012

Status Verified

September 1, 2012

Enrollment Period

3.1 years

First QC Date

October 25, 2010

Last Update Submit

September 21, 2012

Conditions

Osteoarthritis

Keywords

Mechanical muscle functionMuscle strengthHip replacementOsteoarthritisHip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Maximal muscle strength (Peak torque, Nm)

    Maximal muscle strength (peak torque, Nm) during maximal voluntary unilateral knee extension-flexion (seated), hip extension-flexion, and hip adduction-abduction (standing), respectively. Both the affected (AF) and non-affected (NA) leg

    52 wks post-surgery (primary endpoint)

Secondary Outcomes (3)

  • Rapid force capacity (Rate of torque development, Nm/sec)

    52 wks post-surgery (primary endpoint)

  • Gait parameters

    26 wks post-surgery (primary endpoint)

  • Postural Control

    52 wks post-surgery (primary endpoint)

Study Arms (2)

Resurfacing Total Hip Arthroplasty

EXPERIMENTAL

A hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint. Articular surface replacement ASR, DePuy posterolateral approach used (RTHA)

Procedure: Articular Surface Replacement (ASR)

Standard Total Hip Arthroplasty (THA)

ACTIVE COMPARATOR

A standard 28 mm head uncemented THA

Procedure: Standard Total Hip Arthroplasty (THA)

Interventions

Articular Surface Replacement (ASR)PROCEDURE

Articular surface replacement, DePuy, posterolateral approach used

Resurfacing Total Hip Arthroplasty
Standard Total Hip Arthroplasty (THA)PROCEDURE

Device: Biomet 28mm

Standard Total Hip Arthroplasty (THA)

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary arthrosis

You may not qualify if:

  • Osteoporosis, (T-score \< 2.5 SD) of proximal femur
  • BMI \> 35
  • Severe acetabulum dysplasia (AP centre edge \< 15-20°)
  • Femur anteversion \> 25°
  • Severe caput deformity
  • Leg length discrepancy \> 1 cm
  • Off-set problems
  • Earlier fracture of the ipsilateral proximal femur
  • Rheumatoid arthritis
  • Neuromuscular or vascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Research Unit, Dept. of Orthopaedic Surgery and Traumatology, Odense University Hospital, Inst. of Clinical Research - University of Southern Denmark

Odense, 5000, Denmark

Location

Related Publications (2)

  • Jensen C, Rosenlund S, Nielsen DB, Overgaard S, Holsgaard-Larsen A. The use of the Gait Deviation Index for the evaluation of participants following total hip arthroplasty: An explorative randomized trial. Gait Posture. 2015 Jun;42(1):36-41. doi: 10.1016/j.gaitpost.2015.02.009. Epub 2015 Apr 28.

    PMID: 25957650DERIVED

  • Jensen C, Aagaard P, Overgaard S. Recovery in mechanical muscle strength following resurfacing vs standard total hip arthroplasty - a randomised clinical trial. Osteoarthritis Cartilage. 2011 Sep;19(9):1108-16. doi: 10.1016/j.joca.2011.06.011. Epub 2011 Jun 28.

    PMID: 21749928DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Søren Overgaard, Prof., MD., PhD

    Odense University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD-fellow

Study Record Dates

First Submitted

October 25, 2010

First Posted

October 27, 2010

Study Start

February 1, 2007

Primary Completion

March 1, 2010

Study Completion

November 1, 2011

Last Updated

September 25, 2012

Record last verified: 2012-09

Locations

DK(1)