Trial Outcomes & Findings for The Assessment of Patient Specific Instrumentation for Unicompartmental Knee Replacement (NCT NCT02748096)

NCT ID: NCT02748096

Last Updated: 2021-11-16

Results Overview

Radiological assessment of component positioning and alignment based on post-operative knee radiographs.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: Within a weeks after surgery
• Results posted on: 2021-11-16

Participant Flow

Participant milestones

Measure	Patient Specific Instrumentation Patients undergoing unicompartmental knee replacement with the additional aid of patient specific instrumentation. Patient Specific Instrumentation: Patients will undergo a medial unicompartmental knee replacement. This knee replacement is implanted using patient specific cutting guides that have been produced based on the patient's individual anatomy (using plans from pre-operative MRI scans of the patient's knee).	Conventional Instrumentation Patients undergoing unicompartmental knee replacement using standard instrumentation. Conventional Instrumentation: Patients will undergo a medial unicompartmental knee replacement using standard conventional instruments.
Overall Study STARTED	23	22
Overall Study COMPLETED	23	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Assessment of Patient Specific Instrumentation for Unicompartmental Knee Replacement

Baseline characteristics by cohort

Measure	Patient Specific Instrumentation n=23 Participants Patients undergoing unicompartmental knee replacement with the additional aid of patient specific instrumentation. Patient Specific Instrumentation: Patients will undergo a medial unicompartmental knee replacement. This knee replacement is implanted using patient specific cutting guides that have been produced based on the patient's individual anatomy (using plans from pre-operative MRI scans of the patient's knee).	Conventional Instrumentation n=22 Participants Patients undergoing unicompartmental knee replacement using standard instrumentation. Conventional Instrumentation: Patients will undergo a medial unicompartmental knee replacement using standard conventional instruments.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Age, Continuous	66.80 years STANDARD_DEVIATION 7.17 • n=5 Participants	68.18 years STANDARD_DEVIATION 10.40 • n=7 Participants	67.50 years STANDARD_DEVIATION 8.82 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United Kingdom	23 participants n=5 Participants	22 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: Within a weeks after surgery

Radiological assessment of component positioning and alignment based on post-operative knee radiographs.

Outcome measures

Measure	Patient Specific Instrumentation n=23 Participants Patients undergoing unicompartmental knee replacement with the additional aid of patient specific instrumentation. Patient Specific Instrumentation: Patients will undergo a medial unicompartmental knee replacement. This knee replacement is implanted using patient specific cutting guides that have been produced based on the patient's individual anatomy (using plans from pre-operative MRI scans of the patient's knee).	Conventional Instrumentation n=22 Participants Patients undergoing unicompartmental knee replacement using standard instrumentation. Conventional Instrumentation: Patients will undergo a medial unicompartmental knee replacement using standard conventional instruments.
Radiological Assessment of Component Positioning Femur: varus/valgus angle	0.9 Degrees Standard Deviation 4.0	1.8 Degrees Standard Deviation 3.0
Radiological Assessment of Component Positioning Femur: flexion/extension angle	9.1 Degrees Standard Deviation 3.0	8.8 Degrees Standard Deviation 4.8
Radiological Assessment of Component Positioning Tibia: varus/valgus angle	3.5 Degrees Standard Deviation 2.9	8.8 Degrees Standard Deviation 4.8
Radiological Assessment of Component Positioning Tibia:posterior tilt angle	3.5 Degrees Standard Deviation 2.9	4 Degrees Standard Deviation 2.1
Radiological Assessment of Component Positioning Tibia: posterior tilt angle	1.8 Degrees Standard Deviation 2.8	3.7 Degrees Standard Deviation 2.1
Radiological Assessment of Component Positioning Tibia: medial fit	0 Degrees Standard Deviation 1.0	1.0 Degrees Standard Deviation 1.3
Radiological Assessment of Component Positioning Tibia: anterior fit	1.0 Degrees Standard Deviation 0.9	1.0 Degrees Standard Deviation 0.7
Radiological Assessment of Component Positioning Tibia: posterior fit	0 Degrees Standard Deviation 0.8	0 Degrees Standard Deviation 0.9

SECONDARY outcome

Timeframe: One year after surgery

Use of the patient reported outcome tool (Oxford Knee Score) to determine functional outcome at one year following surgery.

Total score is 48. Minimum score 0 and Maximum score 48 with higher score indicating better function.

Scores on a scale

Outcome measures

Measure	Patient Specific Instrumentation n=23 Participants Patients undergoing unicompartmental knee replacement with the additional aid of patient specific instrumentation. Patient Specific Instrumentation: Patients will undergo a medial unicompartmental knee replacement. This knee replacement is implanted using patient specific cutting guides that have been produced based on the patient's individual anatomy (using plans from pre-operative MRI scans of the patient's knee).	Conventional Instrumentation n=22 Participants Patients undergoing unicompartmental knee replacement using standard instrumentation. Conventional Instrumentation: Patients will undergo a medial unicompartmental knee replacement using standard conventional instruments.
Assessment of Functional Outcome	18.3 score on a scale Interval 4.0 to 31.0	18.2 score on a scale Interval 5.0 to 31.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Within the first 48 hours after surgery

Population: Mean drop in post-operative Haemoglobin

Change in haemoglobin levels between baseline and 48 hours after surgery will be determined

Outcome measures

Measure	Patient Specific Instrumentation n=23 Participants Patients undergoing unicompartmental knee replacement with the additional aid of patient specific instrumentation. Patient Specific Instrumentation: Patients will undergo a medial unicompartmental knee replacement. This knee replacement is implanted using patient specific cutting guides that have been produced based on the patient's individual anatomy (using plans from pre-operative MRI scans of the patient's knee).	Conventional Instrumentation n=22 Participants Patients undergoing unicompartmental knee replacement using standard instrumentation. Conventional Instrumentation: Patients will undergo a medial unicompartmental knee replacement using standard conventional instruments.
Post-operative Change in Haemoglobin Between Baseline Baseline and 48 Hours After Surgery	1.66 g/dl Standard Deviation 0.79	1.80 g/dl Standard Deviation 0.59

OTHER_PRE_SPECIFIED outcome

Timeframe: Within the first 48 hours after surgery

Number of Participants with The Need for Blood Transfusion within 48 hours of Surgery

Outcome measures

Measure	Patient Specific Instrumentation n=23 Participants Patients undergoing unicompartmental knee replacement with the additional aid of patient specific instrumentation. Patient Specific Instrumentation: Patients will undergo a medial unicompartmental knee replacement. This knee replacement is implanted using patient specific cutting guides that have been produced based on the patient's individual anatomy (using plans from pre-operative MRI scans of the patient's knee).	Conventional Instrumentation n=22 Participants Patients undergoing unicompartmental knee replacement using standard instrumentation. Conventional Instrumentation: Patients will undergo a medial unicompartmental knee replacement using standard conventional instruments.
Number of Participants With The Need for Blood Transfusion Following Surgery	0 Participants	0 Participants

Adverse Events

Patient Specific Instrumentation

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Instrumentation

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Patient Specific Instrumentation n=23 participants at risk Patients undergoing unicompartmental knee replacement with the additional aid of patient specific instrumentation. Patient Specific Instrumentation: Patients will undergo a medial unicompartmental knee replacement. This knee replacement is implanted using patient specific cutting guides that have been produced based on the patient's individual anatomy (using plans from pre-operative MRI scans of the patient's knee).	Conventional Instrumentation n=22 participants at risk Patients undergoing unicompartmental knee replacement using standard instrumentation. Conventional Instrumentation: Patients will undergo a medial unicompartmental knee replacement using standard conventional instruments.
Musculoskeletal and connective tissue disorders Superficial wound infection	4.3% 1/23 • Number of events 1	4.5% 1/22 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Professor Anrew Price

University of Oxford

Phone: +44 1865 223421

Email: andrew.price@ndorms.ox.ac.uk

Results disclosure agreements

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