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Gait Analyses After Resurfacing Hip Arthroplasty Versus Metal on Metal Total Hip Arthroplasty, an Exploratory Study

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ClinicalTrials.gov Identifier: NCT02484781
Recruitment Status : Completed
First Posted : June 30, 2015
Last Update Posted : July 15, 2016
Sponsor:
Collaborator:
RMC Groot Klimmendaal
Information provided by (Responsible Party):
Job van Susante, Rijnstate Hospital

Brief Summary:
Total hip replacement surgery is a very successful operation with good long-term results. Hip resurfacing arthroplasty is offered as a treatment option for young and active patients with osteoarthritis of the hip. It has been proposed as a treatment option for younger patients because of claims that it preserves femoral bone stock and has better functional outcomes. The assessment of gait after hip replacement surgery may be able to determine functional differences between patients who have undergone total hip replacement / arthroplasty (THA) versus hip resurfacing.

Condition or disease Intervention/treatment Phase
Difficulty Walking Gait, Stumbling Other: Gait analysis on a trendmill Not Applicable

Detailed Description:

A group of 58 patients, part of a ungoing randomized trial comparing resurfacing hip arthroplasty to metal-on-metal total hip arthroplasty, will be invited to a single gait analysis on a trendmill. All patients have reached a follow up of five years. Patient 's gait will be assessed during two walking sessions, in both sessions spatio-temporal, kinetic and kinematic parameters will be recorded.

  • At first when flat walking with increasing speeds to their top walking speed.
  • Secondly: when walking at a fixed speed with an increasing incline to their top walking incline.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Gait Analyses After Resurfacing Hip Arthroplasty Versus Metal on Metal Total Hip
Study Start Date : December 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Active Comparator: Total Hip Arthroplasty
Gait analysis on a trendmill of patients with a well functioning total hip arthroplasty on a trendmill
Other: Gait analysis on a trendmill
Gait analysis on a trendmill "GRAIL" to analyse spatio-temporal kinetics and kinematics when flat walking and inclining
Other Name: Gait realtime analysis interactive lab: MOTEK Medical

Active Comparator: Resurfacing Hip Arthroplasty
Gait analysis on a trendmill of patients with a well functioning resurfacing hip arthroplasty on a trendmill
Other: Gait analysis on a trendmill
Gait analysis on a trendmill "GRAIL" to analyse spatio-temporal kinetics and kinematics when flat walking and inclining
Other Name: Gait realtime analysis interactive lab: MOTEK Medical




Primary Outcome Measures :
  1. Top walking speed [ Time Frame: 5 years postoperative ]
    Mean top walking speed in kilometers / hour assessed on a trendmill

  2. Walking cadence [ Time Frame: 5 years postoperative ]
    Mean steps / minute at top walking speed assessed on a trendmill

  3. Step length [ Time Frame: 5 years postoperative ]
    Mean step distance in meters at top walking speed assessed on a trendmill

  4. Maximum Push off force (N/kg) per cycle [ Time Frame: 5 years postoperative ]
    Mean ground reaction forces in Newton / kilogram on a trendmill

  5. Maximum weight acceptance (N/kg) per cycle [ Time Frame: 5 years postoperative ]
    Mean ground reaction forces assessed on a trendmill

  6. Mid-stance force (N/kg) per cycle [ Time Frame: 5 years postoperative ]
    Mean ground reaction forces assessed on a trendmill

  7. Hip maximum flexion/extension per cycle [ Time Frame: 5 years postoperative ]
    Mean hip kinematics in degrees assessed on a trendmill

  8. Hip maximum internal/external rotation per cycle [ Time Frame: 5 years postoperative ]
    Mean hip kinematics in degrees assessed on a trendmill


Secondary Outcome Measures :
  1. Postoperative hip functionality after hip arthroplasty. [ Time Frame: 5 years postoperative ]
    Postoperative hip function according the Harris Hip Score and Western Ontario and McMaster Universities Osteoarthritis Index

  2. General Health according EurQol-5D [ Time Frame: 5 years postoperative ]
    Health outcome on the EQ-5D questionairre

  3. Physical activity level according the UCLA-activity score [ Time Frame: 5 years postoperative ]
    The University of California at Los Angeles (UCLA) activity score



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient part of randomised controlled trial (RCT) of hip resurfacing versus MoM total hip arthroplasty for symptomatic osteoarthritis of the hip
  • Patient must be able to consent to the study (written informed consent)
  • Patients who are functioning well post-operatively and not under routine follow up
  • Patients who are able to walk without any safety rail assistance on the treadmill

Exclusion Criteria:

  • Patient not originally randomised during an RCT of hip resurfacing versus MoM total hip arthroplasty
  • Patients who suffer from any neurological or musculoskeletal conditions that might make a gait test dangerous.
  • Patients whose cognitive function prevents them from understanding the study
  • Patients who have had or are awaiting revision surgery for their hip

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484781


Locations
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Netherlands
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800WC
Sponsors and Collaborators
Rijnstate Hospital
RMC Groot Klimmendaal
Investigators
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Principal Investigator: Job LC Susante, Dr Rijnstate Hospital, orthopedic surgeon

Publications:
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Responsible Party: Job van Susante, Dr. JLC van Susante, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT02484781     History of Changes
Other Study ID Numbers: LTC 2015-0576
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: July 15, 2016
Last Verified: July 2016

Keywords provided by Job van Susante, Rijnstate Hospital:
Gait disorder
Resurfacing Hip Arthroplasty
Total Hip Arthroplasty

Additional relevant MeSH terms:
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Mobility Limitation
Gait Disorders, Neurologic
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases