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

Difficulty Walking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484781
• Other study ID #: LTC 2015-0576
• Status: Completed
• Phase: N/A
• First received: June 9, 2015
• Last updated: July 14, 2016
• Start date: December 2015
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Difficulty Walking
• Gait Disorders, Neurologic
• Gait, Stumbling
• Mobility Limitation

Intervention

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

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	RMC Groot Klimmendaal

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Top walking speed	Mean top walking speed in kilometers / hour assessed on a trendmill	5 years postoperative	No
Primary	Walking cadence	Mean steps / minute at top walking speed assessed on a trendmill	5 years postoperative	No
Primary	Step length	Mean step distance in meters at top walking speed assessed on a trendmill	5 years postoperative	No
Primary	Maximum Push off force (N/kg) per cycle	Mean ground reaction forces in Newton / kilogram on a trendmill	5 years postoperative	No
Primary	Maximum weight acceptance (N/kg) per cycle	Mean ground reaction forces assessed on a trendmill	5 years postoperative	No
Primary	Mid-stance force (N/kg) per cycle	Mean ground reaction forces assessed on a trendmill	5 years postoperative	No
Primary	Hip maximum flexion/extension per cycle	Mean hip kinematics in degrees assessed on a trendmill	5 years postoperative	No
Primary	Hip maximum internal/external rotation per cycle	Mean hip kinematics in degrees assessed on a trendmill	5 years postoperative	No
Secondary	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	No
Secondary	General Health according EurQol-5D	Health outcome on the EQ-5D questionairre	5 years postoperative	No
Secondary	Physical activity level according the UCLA-activity score	The University of California at Los Angeles (UCLA) activity score	5 years postoperative	No