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

Sponsor

Rijnstate Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02484781

Collaborator

RMC Groot Klimmendaal (Other)

Enrollment

Location

Arms

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Dec 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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