Plain English Summary
Background and study aims
Osteoarthritis of the hip is a common condition that develops with advancing age. It is usually caused by the wear and tear of the cartilage that lines the hip joint, causing bones to rub against each other. This results in pain, stiffness and a loss in mobility. When pain becomes uncontrollable, a total hip replacement (THR) surgery is often performed. This requires for the hip joint to be replaced with a prosthesis (an artificial hip). The prosthesis includes a head and a stem. Typically, the most reliable option is a traiditional stem. However, due to the age of patients requiring hip replacements, a short-stem could allow surgeons to preserve more bone, especially if they need another surgery (revision surgery). There have been a number of short-stem designs. The aim of this study is to review the outcomes of patients who receives a partial neck-retaining short stem and ceramic-on-ceramic bearings in patients younger than 60 to see what the long term impact is.
Who can participate?
Patients younger than 60 years who require hip replacement
What does the study involve?
Eligible participants undergo a hip replacement surgery according to the standard of care. They are given a partial neck-retaining short-stem and either a 32-mm or 36-mm diameter ceramic head is implanted. A ceramic liner is used in all hips. Participants receive the standard postoperative care and are followed up after surgery, one, three, six and 12 months after surgery to assess their symptoms and surgery outcomes and then receive yearly follow up appointments.
What are the possible benefits and risks of participating?
Participants may benefit from receiving the shorter stem prosthesis, which may allow to preserve more bone stock which is helpful for revision surgery. There are risks associated with THR surgery, however there are no additional risks associated with participating in this study in comparison to an identical patient receiving an identical THR.
Where is the study run from?
University of Cagliari (Italy)
When is the study starting and how long is it expected to run for?
January 2006 to December 2012
Who is funding the study?
Smith and Nephew Orthopaedic (UK)
Who is the main contact?
Prof. Antonio Capone
anto.capone@tiscali.it
Trial website
Contact information
Type
Public
Primary contact
Dr Giuseppe Marongiu
ORCID ID
http://orcid.org/0000-0003-2163-454X
Contact details
Orthopaedic Clinic
Department of Surgical Science
University of Cagliari
Ospedale Marino
Lungomare Poetto 12
Cagliari
09126
Italy
Type
Scientific
Additional contact
Prof Antonio Capone
ORCID ID
http://orcid.org/0000-0001-8032-8951
Contact details
Orthopaedic Clinic
Department of Surgical Science
University of Cagliari
Ospedale Marino
Lungomare Poetto 12
Cagliari
09126
Italy
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01_2015
Study information
Scientific title
Short stem total hip arthroplasty for osteonecrosis of the femoral head in patients 60 years or younger: analysis of clinical and radiological results using validated scoring instruments at 3 to 10 year follow-up
Acronym
Study hypothesis
The aim of the study is to evaluate short-stem total hip arthroplasties for osteonecrosis of the femoral head in patients 60 years or younger.
Ethics approval
Institutional Review Board, Surgery Department at Cagliari State University, 24/03/2015, ref: verbale4/24/03/2015_13
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Orthopedics; hip arthroplasty; osteonecrosis of the femoral head
Intervention
Participants undergoing total hip arthroplasties (THAs) due to osteonecrosis of the femoral head as part of their normal surgical care are eligible for this study. Participants have their demographic data recorded (age, sex, cause of osteonecrosis) and their osteonecrosis graded according Steinberg Classification.
All patients receive a partial neck-retaining short-stem (NANOS®; Smith and Nephew, Marl, Germany). Either a 32- or 36-mm diameter ceramic femoral head (BIOLOX-forte; CeramTec, Plochingen, Germany) is implanted. A cementless porous-coated acetabular shell (EP-FIT PLUSTM; Smith and Nephew, Marl, Germany), is used in all hips, ranging from 46 to 58 mm. A ceramic liner (BIOLOX-forte; CeramTec, Plochingen, Germany) is placed in all participants.
All procedures are performed through a modified Hardinge approach, in supine position. After femoral head resection, at least 10mm from the base of the great trochanter and perpendicular to the femoral neck, the femoral path is prepared with cancellous bone compactors. The stem is then inserted with a press-fit technique. In all cases, the acetabulum is reamed line-to-line or 1 mm more than the diameter of the component used. Following surgery, the patients are allowed to stand on the first postoperative day and progress to full weight-bearing with crutches. Patients are recommended to use a pair of crutches for 4 weeks.
Clinical and radiographic follow-up is performed at one months, three months, six months, 12 months and then yearly thereafter using validated scored. Evidence of any clicking or squeaking sound emanating from the ceramic-on-ceramic bearing is recorded. Postoperative radiographs are taken to be evaluated for hip geometry restoration (center of rotation, offset and limb length), bone-implant fixation and osteolysis. The stability of the acetabular component, any site of acetabular osteolysis and migration is assessed. Femoral stem fixation is investigated.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Clinical outcomes are assessed using the Harris hip score (HHS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the UCLA score at baseline, 1, 3, 6, 12 months and yearly for ten years
Secondary outcome measures
Hip geometry restoration (center of rotation, offset and limb length), bone-implant fixation and osteolysis is measured using radiographs at immediately after the surgery and then at 1, 3, 6, 12 months and yearly for ten years
Overall trial start date
25/10/2005
Overall trial end date
01/09/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Indication for implantation of the Nanos short stem due to osteonecrosis of the hip
2. Patients 60 years old or younger
3. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
32
Participant exclusion criteria
1. Older than 60 years
2. Had a follow up of less than 3 years after the operation
Recruitment start date
01/01/2006
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Italy
Trial participating centre
Clinica Ortopedica, Ospedale Marino
Lungomare Poetto 190
Cagliari
09100
Italy
Funders
Funder type
Industry
Funder name
Smith and Nephew Orthopaedics
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal at the end of 2017.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Giuseppe Marongiu (giuse.marongiu@gmail.com).
Intention to publish date
31/12/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28716026