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

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

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.

Study Overview

• Status: Completed
• Conditions: Gait, Stumbling; Difficulty Walking
• Intervention / Treatment: Other: Gait analysis on a trendmill

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6800WC
      • Rijnstate Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Gait realtime analysis interactive lab: MOTEK Medical

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Top walking speed	Mean top walking speed in kilometers / hour assessed on a trendmill	5 years postoperative
Walking cadence	Mean steps / minute at top walking speed assessed on a trendmill	5 years postoperative
Step length	Mean step distance in meters at top walking speed assessed on a trendmill	5 years postoperative
Maximum Push off force (N/kg) per cycle	Mean ground reaction forces in Newton / kilogram on a trendmill	5 years postoperative
Maximum weight acceptance (N/kg) per cycle	Mean ground reaction forces assessed on a trendmill	5 years postoperative
Mid-stance force (N/kg) per cycle	Mean ground reaction forces assessed on a trendmill	5 years postoperative
Hip maximum flexion/extension per cycle	Mean hip kinematics in degrees assessed on a trendmill	5 years postoperative
Hip maximum internal/external rotation per cycle	Mean hip kinematics in degrees assessed on a trendmill	5 years postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative hip functionality after hip arthroplasty.	Postoperative hip function according the Harris Hip Score and Western Ontario and McMaster Universities Osteoarthritis Index	5 years postoperative
General Health according EurQol-5D	Health outcome on the EQ-5D questionairre	5 years postoperative
Physical activity level according the UCLA-activity score	The University of California at Los Angeles (UCLA) activity score	5 years postoperative

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: RMC Groot Klimmendaal
• Investigators: Principal Investigator: Job LC Susante, Dr, Rijnstate Hospital, orthopedic surgeon

Publications and helpful links

General Publications

• Aqil A, Drabu R, Bergmann JH, Masjedi M, Manning V, Andrews B, Muirhead-Allwood SK, Cobb JP. The gait of patients with one resurfacing and one replacement hip: a single blinded controlled study. Int Orthop. 2013 May;37(5):795-801. doi: 10.1007/s00264-013-1819-3. Epub 2013 Feb 27.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: June 9, 2015
• First Submitted That Met QC Criteria: June 25, 2015
• First Posted (ESTIMATE): June 30, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): July 15, 2016
• Last Update Submitted That Met QC Criteria: July 14, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Total Hip Arthroplasty; Gait disorder; Resurfacing Hip Arthroplasty
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Gait Disorders, Neurologic; Mobility Limitation
• Other Study ID Numbers: LTC 2015-0576