Plain English Summary
Background and study aims
Osteoarthritis is the most common disease affecting the joint. It can develop in any joint but it most often affects those that carry weight, such as the hips, spine and knees. It is caused by damage in and around the joint that can’t be fully repaired. Some of the cartilage (the protective layer covering the bones at the joint that ensures the joint moves smoothly) can become damaged or lost, leading to swelling (inflammation), pain and stiffness. Relatively young and more active patients with osteoarthritis (OA) of the isolated medial femorotibial compartment (that is, arthritis of the cartilage between the thigh bone and the shin bone) together with anterior cruciate ligament (ACL) deficiency (tear of the anterior cruciate ligament of the knee) are difficult to treat. The aim of this study was to explore the early clinical outcomes of combined Oxford unicompartmental knee arthroplasty (partial replacement of the knee joint) and ACL reconstruction (tissue graft replacement if the ligament) for patients with ACL deficiency and isolated OA of the medial compartment.
Who can participate?
Adult patients diagnosed of having isolated medial femorotibial compartment OA and ACL deficiency.
What does the study involve?
All patients are treated by combined Oxford UKA and ACL reconstruction. The outcomes of the surgery is then observed over time. This includes the taking of radiographs before and after surgery to look for structural changes of the knee joint. Range of motion is assessed for each patient after surgery and a number of clinical assessments done. This includes testing how stable the knee jpint is, function of the knee and how much pain each patient experiences. All patients are assessed before surgery and then again after 3, 6, 12 and, finally, 24 months.
What are the possible benefits and risks of participating?
The benefits of participating are that the patients with femorotibial OA and ACL deficiency could be treated with the combined procedures of UKA and ACLR within one surgery. It costs the patients less money and the patients could get recovery fast and earlier. The possible risks are that the combined procedures may fail and get complications after surgery.
Where is the study run from?
The Affiliated Hospital of Qingdao University (China)
When is the study starting and how long is it expected to run for?
January 2008 to January 2014
Who is funding the study?
The Affiliated Hospital of Qingdao University (China)
Who is the main contact?
Dr Shaoqi Tian
shaoqi99@aliyun.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Shaoqi Tian
ORCID ID
http://orcid.org/0000-0002-2202-3604
Contact details
No.1677 Wutaishan Road
Huangdao District
Qingdao
266000
China
+8617853290951
shaoqi99@aliyun.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AHQDU267718-6
Study information
Scientific title
Combined unicompartmental knee arthroplasty and anterior cruciate ligament reconstruction in knees with osteoarthritis and deficient anterior cruciate ligament
Acronym
Study hypothesis
Relatively young and more active patients with osteoarthritis (OA) of the isolated medial femorotibial compartment in conjunction with anterior cruciate ligament (ACL) deficiency are difficult to treat. The aim of this study was to explore the early clinical outcomes of combined Oxford unicompartmental knee arthroplasty (UKA) and ACL reconstruction for patients presenting ACL deficiency and isolated OA of the medial compartment.
Ethics approval
Affiliated Hospital of Qingdao University Ethics Committee, 08/10/2007, ref: AHQDU267718-6,
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Unicompartmental knee arthroplasty and anterior cruciate ligament reconstruction
Intervention
All patients were treated by combined Oxford UKA (partial knee replacement) and ACL (anterior cruciate ligament) reconstruction. Plain radiographs in the antero-posterior and lateral view and long-leg standing radiographs were routinely performed prior to and after surgery. Stress radiographs in valgus were additionally available in order to verify the well-preserved lateral compartment. The varus deformity of the knee prior to surgery and the valgus degree after surgery, the posterior slope of the tibial component and the range of motion (ROM) of the knee after surgery were measured and recorded.
Clinical evaluations include Oxford Knee Score (OKS), Knee Society Score (KSS-clinical score; KSS-function score) and Tegner activity score. Follow-up (FU) was done at 1, 3, 6, 12 months after operations and each 1 year thereafter.
Intervention type
Phase
Drug names
Primary outcome measures
1. Patient assessment of levels of, and change in, pain and function of the knee, using the Oxford Knee Score (OKS)
2. Clinical profile (pain intensity, range of motion and stability in the anteroposterior and mediolateral planes, flexion deformities, contractures and poor alignment. ), using KSS-clinical score and KSS-function score
3. Activity levels for daily living, using the Tegner activity score
4. Radiological assessment
Measured before surgery, and then 3, 6, 12 and 24 months after surgery
Secondary outcome measures
Post-operative range of movement, assessed using the KT-2000 arthrometer test, measured before surgery and then 3, 6, 12 and 24 months after surgery
Overall trial start date
01/01/2008
Overall trial end date
01/01/2014
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with isolated medial femorotibial compartment OA secondary to ACL deficiency and primary isolated medial femorotibial OA with acute ACL injury.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
At least 25
Participant exclusion criteria
1. Severe knee OA apart from the femorotibial compartment
2. Multiple ligment injuries
Recruitment start date
05/01/2008
Recruitment end date
30/12/2013
Locations
Countries of recruitment
China
Trial participating centre
The Affiliated Hospital of Qingdao University
No.1677 Wutaishan Road, Huangdao District
Qingdao
266000
China
Sponsor information
Organisation
The Affiliated Hospital of Qingdao University
Sponsor details
No. 16 Jiangsu Road
Qingdao
266000
China
None
shaoqi99@aliyun.com
Sponsor type
Other
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Affiliated Hospital of Qingdao University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary
2016 results in: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4974734