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

Not Applicable

Completed

• Conditions: Gait, Stumbling; Difficulty Walking
• Interventions: Other: Gait analysis on a trendmill

• Registration Number: NCT02484781
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-06-25
• Study First Posted: 2015-06-30
• Study Start: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-14
• Last Update Posted: 2016-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resurfacing Hip Arthroplasty	Gait analysis on a trendmill	Gait analysis on a trendmill of patients with a well functioning resurfacing hip arthroplasty on a trendmill
Total Hip Arthroplasty	Gait analysis on a trendmill	Gait analysis on a trendmill of patients with a well functioning total hip arthroplasty on a trendmill

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Gelderland, Netherlands