Clinical trial NCT02484781: 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
Overall status: COMPLETED
Phase: NA
Conditions: Difficulty Walking
Gait, Stumbling
Keywords: Gait disorder
Resurfacing Hip Arthroplasty
Total Hip Arthroplasty
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: RMC Groot Klimmendaal
First posted: 2015-06-30
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Top walking speed
timeFrame: 5 years postoperative
measure: Walking cadence
timeFrame: 5 years postoperative
measure: Step length
timeFrame: 5 years postoperative
measure: Maximum Push off force (N/kg) per cycle
timeFrame: 5 years postoperative
measure: Maximum weight acceptance (N/kg) per cycle
timeFrame: 5 years postoperative
measure: Mid-stance force (N/kg) per cycle
timeFrame: 5 years postoperative
measure: Hip maximum flexion/extension per cycle
timeFrame: 5 years postoperative
measure: Hip maximum internal/external rotation per cycle
timeFrame: 5 years postoperative
Secondary outcomes:
measure: Postoperative hip functionality after hip arthroplasty.
timeFrame: 5 years postoperative
measure: General Health according EurQol-5D
timeFrame: 5 years postoperative
measure: Physical activity level according the UCLA-activity score
timeFrame: 5 years postoperative
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
Study officials:
affiliation: Rijnstate Hospital, orthopedic surgeon
name: Job LC Susante, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.