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NCT Number: NCT02484781

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

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.

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Key information

Conditions

Difficulty Walking Gait Disorders, Neurologic Gait, Stumbling Mobility Limitation Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate Hospital

Arnhem, Gelderland, 6800WC, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gait analysis on a trendmill

Other

Gait analysis on a trendmill "GRAIL" to analyse spatio-temporal kinetics and kinematics when flat walking and inclining

Other names: Gait realtime analysis interactive lab: MOTEK Medical

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Collaborators

  • RMC Groot Klimmendaal

Registry information

Official study title

Gait Analyses After Resurfacing Hip Arthroplasty Versus Metal on Metal Total Hip

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 30, 2015
Registry last updated
Jul 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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