Univation X Partial Knee Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-29

Study Completion Date

2023-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to investigate the functional and clinical outcome after medial unicompartmental knee replacement using the Aesculap AG Univation X knee prosthesis compared to pre-operative data and a healthy control group.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Univation® X Follow-Up Study

NCT03201172

Unicompartmental Knee Arthroplasty

COMPLETED

Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant

NCT06657248

Gonarthritis Degenerative Disease

NOT_YET_RECRUITING

Univation XM France

NCT04199481

Osteoarthritis, Knee Osteoarthrosis of Knee Arthritis Knee +1 more

WITHDRAWN

Safety and Efficacy of the Oxford Cementless Partial Knee System

NCT01473134

Osteoarthritis, Knee Avascular Necrosis of the Medial Femoral Condyle

COMPLETED NA

Oxford Partial Knee Replacement. A Randomized Clinical Trial of Three Implant Types

NCT00679120

Osteoarthritis, Knee

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

All potential medial uni-compartmental knee arthroplasty patients from consultant orthopaedic surgeons at the Golden Jubilee National Hospital (GJNH) will be screened in relation to the inclusion/exclusion criteria. Invitation letters and participant information sheets (PIS) will be sent out to suitable patients who have been referred to the GJNH for a knee replacement (allocated patients) prior to their pre-operative consultation with their surgeon. They will be approached at their consultation visit to seek consent to take part in the study. Patients who have been referred to the GJNH for assessment for a knee replacement (see and treat patients) will be approached only if they are deemed eligible for uni-compartmental knee replacement by their consultant, and will be given a copy of the participant information sheet along with the invitation letter. They will be approached for consent to take part in the study at their pre-operative assessment. All patients will be contacted by telephone around a day after receiving the participant information sheet to ask for verbal consent. This is necessary to arrange the pre-operative CT scans and biomechanical testing. All patients will be given the opportunity to ask questions about the study before signing the consent form. Consent will be taken by the chief investigator or their delegate, using a signed form.

Thirty patients will be recruited to the study. They will have their surgery performed by one of the participating consultants using the study implant, the Univation X unicondylar knee system manufactured by Aesculap AG.

Participants will receive their standard in-patient care and rehabilitation. Standard hospital care for knee arthroplasty patients is for them to return to the hospital for a post-operative review at 6 weeks and then 1 year after operation. Study participants will also be asked to attend the GJNH for one additional research specific appointment at two years post-operatively.

During the standard care appointments, patients will be reviewed by a member of the arthroplasty team who will collect routine data on the clinical and functional outcomes and implant stability. These data include the Oxford Knee Score (OKS), EURO Quality of life questionnaire (EQ-5D 5L), patient satisfaction and standard radiographic assessment of the implant.

Detailed radiographic analysis will be carried out on radiographs collected as standard practice and computed tomography (CT) scans taken specifically for the study. Radiographs will be taken pre-operatively, post-operation at day one (standard), 1 year (standard) and the 2 year (study) time points. Patients will have a CT scan pre-operatively and 6 weeks post-operatively. The post-operative scan will be performed instead of the radiographs usually take at this time point. The pre-operative scan will be performed in addition to the pre-operative radiographs.

Study participants will also have two sessions of specialised functional assessment using clinical movement analysis before surgery and 1 year after surgery during their standard pre- and post-operative visits. Biomechanical movement analysis will be carried out in an on-site movement analysis laboratory. Study participants will be required to wear suitable clothing (e.g. tee shirt and shorts) and be barefoot. A number of reflective markers will be attached to specific locations on the body (using suitable double sided tape) which will be tracked by a number of infrared cameras. Participants will be asked to perform the following tasks; level walking, incline walking, decline walking, stand-to-sit-to-stand, step ascent and descent and single leg balance. Each task will be performed at least three times to enable the collection of three good sets of data. In addition, the two stepping tasks will be repeated for each limb. The single leg balance will be performed once for each leg and data will be collected for 30 seconds per limb. A motion capture system will collect limb and torso movements during the task performances while force plates will collect ground reaction forces.

After the two year follow-up appointment the patients involvement in the study will be complete.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Uni-condylar knee arthroplasty

A cohort of patients who will undergo uni-condylar knee replacement surgery with the Univation X system and have biomechanical anaylsis

Uni-condylar knee arthroplasty

Intervention Type PROCEDURE

Surgical replacement of medial compartment of arthritic knee with an implant

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Uni-condylar knee arthroplasty

Surgical replacement of medial compartment of arthritic knee with an implant

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

uni-condylar knee replacement

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients having medial uni-compartmental knee arthroplasty Functionally intact anterior cruciate ligament Able to give informed consent Able to return to GJNH for follow-up BMI under 40

Exclusion Criteria

* Inflammatory joint disease e.g. rheumatoid arthritis Previous hip procedure in the last twelve months Previous knee surgery other than arthroscopy and medial menisectomy Previous ankle surgery Symptomatic foot, hip or spinal pathology Any medical condition limiting normal ambulation e.g. stroke, Charcot-Marie-Tooth disease, severe lymphedema, advanced cardiac disease

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No