Osteoarthritis
Conditions
Keywords
Unicondylar Knee Replacement
Brief summary
The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first six years following Oxford Medial Unicondylar Knee prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest.
Detailed description
The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first six years following Oxford Medial Unicondylar Knee prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest. Thats it!
Interventions
None listed
Sponsors
South-Eastern Norway Regional Health Authority
Vestre Viken Hospital Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients with medial knee osteoarthritis * admitted for unicondylar knee replacement * age 50-80 years
Exclusion criteria
* rheumatoid arthritis * previous knee infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score | Preoperative until 2 years postoperatively | Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best. |
Secondary
| Measure | Time frame |
|---|---|
| Range of Motion | Preoperative until 2 years postoperatively |
| Oxford Knee Score | Preoperative until 2 years postoperatively |
| UCLA Score | Preoperative until 2 years postoperatively |
| Knee Injury and Osteoarthritis Outcome Score | 10 years postoperatively |
Countries
Norway
Participant flow
Recruitment details
All recruited from Martina Hansens Hospitals patients
Participants by arm
| Arm | Count |
|---|---|
| Patients With Knee Osteoarthritis Patients eglible for medial unicompartmental knee replacement | 96 |
| Total | 96 |
Baseline characteristics
| Characteristic | Patients With Knee Osteoarthritis |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 54 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 6.5 |
| Region of Enrollment Norway | 96 participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 96 |
| serious Total, serious adverse events | 5 / 96 |
Outcome results
Primary
Knee Injury and Osteoarthritis Outcome Score
Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best.
Time frame: Preoperative until 2 years postoperatively
| Arm | Measure | Value (MEAN) |
|---|---|---|
| KOOS Pain 2 Years | Knee Injury and Osteoarthritis Outcome Score | 85.5 units on a scale |
| KOOS ADL 2 Years | Knee Injury and Osteoarthritis Outcome Score | 88.2 units on a scale |
Secondary
Knee Injury and Osteoarthritis Outcome Score
Time frame: 10 years postoperatively
Secondary
Oxford Knee Score
Time frame: Preoperative until 2 years postoperatively
Secondary
Oxford Knee Score
Time frame: 10 years postoperatively
Secondary
Range of Motion
Time frame: Preoperative until 2 years postoperatively
| Arm | Measure | Value (MEAN) |
|---|---|---|
| KOOS Pain 2 Years | Range of Motion | 128 degrees |
Secondary
UCLA Score
Time frame: Preoperative until 2 years postoperatively