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

Primary Purpose

Difficulty Walking, Gait, Stumbling

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Gait analysis on a trendmill

About this trial

This is an interventional basic science trial for Difficulty Walking focused on measuring Gait disorder, Resurfacing Hip Arthroplasty, Total Hip Arthroplasty

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Rijnstate Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Total Hip Arthroplasty

Resurfacing Hip Arthroplasty

Arm Description

Gait analysis on a trendmill of patients with a well functioning total hip arthroplasty on a trendmill

Gait analysis on a trendmill of patients with a well functioning resurfacing hip arthroplasty on a trendmill

Outcomes

Primary Outcome Measures

Top walking speed

Mean top walking speed in kilometers / hour assessed on a trendmill

Walking cadence

Mean steps / minute at top walking speed assessed on a trendmill

Step length

Mean step distance in meters at top walking speed assessed on a trendmill

Maximum Push off force (N/kg) per cycle

Mean ground reaction forces in Newton / kilogram on a trendmill

Maximum weight acceptance (N/kg) per cycle

Mean ground reaction forces assessed on a trendmill

Mid-stance force (N/kg) per cycle

Mean ground reaction forces assessed on a trendmill

Hip maximum flexion/extension per cycle

Mean hip kinematics in degrees assessed on a trendmill

Hip maximum internal/external rotation per cycle

Mean hip kinematics in degrees assessed on a trendmill

Secondary Outcome Measures

Postoperative hip functionality after hip arthroplasty.

Postoperative hip function according the Harris Hip Score and Western Ontario and McMaster Universities Osteoarthritis Index

General Health according EurQol-5D

Health outcome on the EQ-5D questionairre

Physical activity level according the UCLA-activity score

The University of California at Los Angeles (UCLA) activity score

Full Information

NCT ID

NCT02484781

First Posted

June 9, 2015

Last Updated

July 14, 2016

Sponsor

Rijnstate Hospital

Collaborators

RMC Groot Klimmendaal

1. Study Identification

Unique Protocol Identification Number

NCT02484781

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

December 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rijnstate Hospital

Collaborators

RMC Groot Klimmendaal

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Difficulty Walking, Gait, Stumbling

Keywords

Gait disorder, Resurfacing Hip Arthroplasty, Total Hip Arthroplasty

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Non-Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Total Hip Arthroplasty

Arm Type

Active Comparator

Arm Description

Gait analysis on a trendmill of patients with a well functioning total hip arthroplasty on a trendmill

Arm Title

Resurfacing Hip Arthroplasty

Arm Type

Active Comparator

Arm Description

Gait analysis on a trendmill of patients with a well functioning resurfacing hip arthroplasty on a trendmill

Intervention Type

Other

Intervention Name(s)

Gait analysis on a trendmill

Other Intervention Name(s)

Gait realtime analysis interactive lab: MOTEK Medical

Intervention Description

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

Primary Outcome Measure Information:

Title

Top walking speed

Description

Mean top walking speed in kilometers / hour assessed on a trendmill

Time Frame

5 years postoperative

Title

Walking cadence

Description

Mean steps / minute at top walking speed assessed on a trendmill

Time Frame

5 years postoperative

Title

Step length

Description

Mean step distance in meters at top walking speed assessed on a trendmill

Time Frame

5 years postoperative

Title

Maximum Push off force (N/kg) per cycle

Description

Mean ground reaction forces in Newton / kilogram on a trendmill

Time Frame

5 years postoperative

Title

Maximum weight acceptance (N/kg) per cycle

Description

Mean ground reaction forces assessed on a trendmill

Time Frame

5 years postoperative

Title

Mid-stance force (N/kg) per cycle

Description

Mean ground reaction forces assessed on a trendmill

Time Frame

5 years postoperative

Title

Hip maximum flexion/extension per cycle

Description

Mean hip kinematics in degrees assessed on a trendmill

Time Frame

5 years postoperative

Title

Hip maximum internal/external rotation per cycle

Description

Mean hip kinematics in degrees assessed on a trendmill

Time Frame

5 years postoperative

Secondary Outcome Measure Information:

Title

Postoperative hip functionality after hip arthroplasty.

Description

Postoperative hip function according the Harris Hip Score and Western Ontario and McMaster Universities Osteoarthritis Index

Time Frame

5 years postoperative

Title

General Health according EurQol-5D

Description

Health outcome on the EQ-5D questionairre

Time Frame

5 years postoperative

Title

Physical activity level according the UCLA-activity score

Description

The University of California at Los Angeles (UCLA) activity score

Time Frame

5 years postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Job LC Susante, Dr

Organizational Affiliation

Rijnstate Hospital, orthopedic surgeon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rijnstate Hospital

City

Arnhem

State/Province

Gelderland

ZIP/Postal Code

6800WC

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

23443980

Citation

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.

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

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