Condition category
Musculoskeletal Diseases
Date applied
12/07/2016
Date assigned
21/07/2016
Last edited
20/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://qyfy.cn/

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

Publication citations

Additional files

Editorial Notes