Combined unicompartmental knee arthroplasty (UKA) and anterior cruciate ligament (ACLR) study

ISRCTN ISRCTN24663935
DOI https://doi.org/10.1186/ISRCTN24663935
Secondary identifying numbers AHQDU267718-6
Submission date
12/07/2016
Registration date
21/07/2016
Last edited
22/02/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Shaoqi Tian
Scientific

No.1677 Wutaishan Road, Huangdao District
Qingdao
266000
China

ORCiD logoORCID ID 0000-0002-2202-3604
Phone +8617853290951
Email shaoqi99@aliyun.com

Study information

Study designObservational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titleCombined unicompartmental knee arthroplasty and anterior cruciate ligament reconstruction in knees with osteoarthritis and deficient anterior cruciate ligament
Study objectivesRelatively 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(s)Affiliated Hospital of Qingdao University Ethics Committee, 08/10/2007, ref: AHQDU267718-6,
Health condition(s) or problem(s) studiedUnicompartmental knee arthroplasty and anterior cruciate ligament reconstruction
InterventionAll 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
Primary outcome measure1. 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 measuresPost-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 study start date01/01/2008
Completion date01/01/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsAt least 25
Key inclusion criteriaPatients with isolated medial femorotibial compartment OA secondary to ACL deficiency and primary isolated medial femorotibial OA with acute ACL injury.
Key exclusion criteria1. Severe knee OA apart from the femorotibial compartment
2. Multiple ligment injuries
Date of first enrolment05/01/2008
Date of final enrolment30/12/2013

Locations

Countries of recruitment

  • China

Study participating centre

The Affiliated Hospital of Qingdao University
No.1677 Wutaishan Road, Huangdao District
Qingdao
266000
China

Sponsor information

The Affiliated Hospital of Qingdao University
Other

No. 16 Jiangsu Road
Qingdao
266000
China

Phone None
Email shaoqi99@aliyun.com
Website http://qyfy.cn/
ROR logo "ROR" https://ror.org/026e9yy16

Funders

Funder type

Hospital/treatment centre

The Affiliated Hospital of Qingdao University

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination plan
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2016 Yes No

Editorial Notes

22/02/2018: Publication reference added