NCT02854189

Brief Summary

The purpose of this study is to explore the effects of the Oxford unicompartmental knee arthroplasty on two groups of patients, namely one with genu recurvatum before the procedure and one without. Specifically, this study compare the number of occurrences of postoperative genu recurvatum and the postoperative hyperextension angles among the patients. Additionally, the knee scores, the pain scores, and the functional scores for the two groups of patients are compared. Materials and methods: This study prospectively followed 104 patients (114 knees) who had been treated with cemented minimally invasive surgery unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up. The patients were divided into two groups: those without preoperative genu recurvatum (85 patients; 94 knees) and those with preoperative genu recurvatum (19 patients; 20 knees). The incidence of the postoperative genu recurvatum, the postoperative hyperextension angles, the knee scores, the pain scores, and the functional scores were recorded and compared between two groups..

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
Last Updated

June 4, 2020

Status Verified

July 1, 2016

Enrollment Period

2.2 years

First QC Date

June 6, 2016

Last Update Submit

June 1, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • hyperextension angle, the incidence of postoperative genu recurvatum

    hyperextension angle, the incidence of postoperative genu recurvatum

    2 years

Study Arms (2)

patients with genu recurvatum

OTHER

The medial osteoarthritis knees with genu recurvatum were included in this study. Patients had been treated with cemented minimally invasive surgery Oxford unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up.The incidence of postoperative genu recurvatum, postoperative hyperextension angle, and the knee society score were recorded.

Device: Oxford unicompartmental knee arthroplasty

patients without genu recurvatum

OTHER

The medial osteoarthritis knees without genu recurvatum were included in this study. Patients had been treated with cemented minimally invasive surgery Oxford unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up.The incidence of postoperative genu recurvatum, postoperative hyperextension angle, and the knee society score were recorded.

Device: Oxford unicompartmental knee arthroplasty

Interventions

The Oxford unicompartmental knee arthroplasty was applied in all patients with medial osteoarthritis knee.The Oxford unicompartmental knee arthroplasty is mobile bearing unicompartmental knee arthroplasty.

patients with genu recurvatumpatients without genu recurvatum

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The medial OA knee with older than 40 years of age, ROM greater than 90°, varus deformity less than 25°, and flexion contractures less than 20°

You may not qualify if:

  • patients who were diagnosed spontaneous osteonecrosis of knee (SPONK), patients with intraoperative ACL insufficiency, post traumatic arthritis, gouty arthritis, inflammatory joints.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 6, 2016

First Posted

August 3, 2016

Study Start

January 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2015

Last Updated

June 4, 2020

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share