Trial Outcomes & Findings for Time-dependent Improvement of Functional Outcome Following Oxford Medial Unicondylar Knee Replacement (NCT NCT01032538)

NCT ID: NCT01032538

Last Updated: 2023-12-01

Results Overview

Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best.

• Recruitment status: COMPLETED
• Target enrollment: 99 participants
• Primary outcome timeframe: Preoperative until 2 years postoperatively
• Results posted on: 2023-12-01

Participant Flow

All recruited from Martina Hansens Hospitals patients

Participant milestones

Measure	Patients With Knee Osteoarthritis Patients eglible for unicondylar knee replacement
Overall Study STARTED	99
Overall Study COMPLETED	99
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Time-dependent Improvement of Functional Outcome Following Oxford Medial Unicondylar Knee Replacement

Baseline characteristics by cohort

Measure	Patients With Knee Osteoarthritis n=96 Participants Patients eglible for medial unicompartmental knee replacement
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants
Age, Categorical >=65 years	54 Participants n=5 Participants
Age, Continuous	65 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Region of Enrollment Norway	96 participants n=5 Participants

PRIMARY outcome

Timeframe: Preoperative until 2 years postoperatively

Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best.

Outcome measures

Measure	KOOS Pain 2 Years n=96 Participants Knee pain score, one of 5 subscores of KOOS	KOOS ADL 2 Years n=96 Participants Activities of dayly living score
Knee Injury and Osteoarthritis Outcome Score	85.5 units on a scale Interval 82.0 to 89.0	88.2 units on a scale Interval 85.0 to 91.0

SECONDARY outcome

Timeframe: Preoperative until 2 years postoperatively

Outcome measures

Measure	KOOS Pain 2 Years n=96 Participants Knee pain score, one of 5 subscores of KOOS	KOOS ADL 2 Years Activities of dayly living score
Range of Motion	128 degrees Interval 123.0 to 130.0	—

SECONDARY outcome

Timeframe: Preoperative until 2 years postoperatively

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Preoperative until 2 years postoperatively

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 years postoperatively

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 years postoperatively

Outcome measures

Outcome data not reported

Adverse Events

Patients With Knee Osteoarthritis

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Patients With Knee Osteoarthritis n=96 participants at risk Patients eglible for unicompartmental knee replacement
Musculoskeletal and connective tissue disorders Revision to total knee arthroplasty	5.2% 5/96 • Number of events 5 96 patients with 99 knees included in the study

Other adverse events

Adverse event data not reported

Additional Information

Tor Kjetil Nerhus

Martina Hansens Hospital

Phone: +47 93409934

Email: kjnerhus@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place