Cemented Versus Cementless Unicompartmental Knee Arthroplasty

NCT05935878 | Completed Results FDA Device

• 1 other identifier: PID7088
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

Unicompartmental knee replacement for selected cases of osteoarthritis is less invasive than total knee replacement. It gives better range of movement; patients stay for shorter time in the hospital and have a more natural feel than total knee replacement. Usually, the implant is fixed in the bone using bone cement. However, there are potential disadvantages of using bone cement. The operation takes longer; cement can get squeezed out into the surrounding tissues and may interfere with function. To avoid these problems, the implant can be fixed without cement. Cementless components have a special coating to encourage bone in-growth and fixation. Although the investigators believe cementless fixation will be at least as good as cemented fixation, there is a risk that it could be worse and might result in loosening. The aim of this study is therefore to compare the outcome of cemented and cementless unicompartmental knee replacement.

Conditions

Osteoarthritis, Knee

Keywords

Knee Arthroplasty; Unicompartmental; Fixation; Radiostereometric Analysis

Outcome Measures

Primary Outcomes (27)

• Radiostereometric Analysis Examination - Translations

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral * Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior * Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior

  Patients will be examined 3 months post surgery.

• Radiostereometric Analysis Examination - Translations

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral * Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior * Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior

  Patients will be examined 6 months post surgery.

• Radiostereometric Analysis Examination - Translations

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral * Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior * Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior

  Patients will be examined 12 months post surgery.

• Radiostereometric Analysis Examination - Translations

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral * Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior * Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior

  Patients will be examined 24 months post surgery.

• Radiostereometric Analysis Examination - Translations

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres.

  Patients will be examined 60 months post surgery.

• Radiostereometric Analysis Examination - Translations

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral * Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior * Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior

  Patients will be examined 120 months post surgery.

• Radiostereometric Analysis Examination - Rotations

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: \*For the Femoral Component\* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus \*For the Tibial Component\* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus

  Patients will be examined at 3 months post surgery.

• Radiostereometric Analysis Examination - Rotations

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * For the Femoral Component\* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus * For the Tibial Component\* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus

  Patients will be examined at 6 months post surgery.

• Radiostereometric Analysis Examination - Rotations

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * For the Femoral Component\* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus * For the Tibial Component\* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus

  Patients will be examined at 12 months post surgery.

• Radiostereometric Analysis Examination - Rotations

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * For the Femoral Component\* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus * For the Tibial Component\* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus

  Patients will be examined at 24 months post surgery.

• Radiostereometric Analysis Examination - Rotations

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * For the Femoral Component\* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus * For the Tibial Component\* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus

  Patients will be examined at 60 months post surgery.

• Radiostereometric Analysis Examination - Rotations

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * For the Femoral Component\* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus * For the Tibial Component\* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus

  Patients will be examined at 120 months post surgery.

• Radiostereometric Analysis Examination - Maximum Total Point Motion

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.

  Patients will be examined at 3 months post surgery.

• Radiostereometric Analysis Examination - Maximum Total Point Motion

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.

  Patients will be examined at 12 months post surgery.

• Radiostereometric Analysis Examination - Maximum Total Point Motion

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.

  Patients will be examined at 24 months post surgery.

• Radiostereometric Analysis Examination - Maximum Total Point Motion

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.

  Patients will be examined at 60 months post surgery.

• Radiostereometric Analysis Examination - Maximum Total Point Motion

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.

  Patients will be examined at 120 months post surgery.

• Radiographic Examination

  Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'.

  Patients will be examined at 12 months post surgery.

• Radiographic Examination

  Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'.

  Patients will be examined at 24 months post surgery.

• Radiographic Examination

  Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'.

  Patients will be examined at 60 months post surgery.

• Radiographic Examination

  Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'.

  Patients will be examined at 120 months post surgery.

• Clinical Assessment

  Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).

  Patients will be assessed pre-operatively.

• Clinical Assessment

  Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).

  Patients will be assessed at 12 months post surgery.

• Clinical Assessment

  Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).

  Patients will be assessed at 24 months post surgery.

• Clinical Assessment

  Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).

  Patients will be assessed at 60 months post surgery.

• Clinical Assessment

  Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).

  Patients will be assessed at 120 months post surgery.

• Radiostereometric Analysis Examination - Maximum Total Point Motion

  Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.

  Patients will be assessed at 6 months post surgery.

Study Arms (2)

Cementless Oxford Unicompartmental Knee Arthroplasty

EXPERIMENTAL

Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)

Device: Cementless Oxford Unicompartmental Knee Arthroplasty

Cemented Oxford Unicompartmental Knee Arthroplasty

ACTIVE COMPARATOR

Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)

Device: Cemented Oxford Unicompartmental Knee Arthroplasty

Interventions

Cementless Oxford Unicompartmental Knee Arthroplasty DEVICE

All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.

Also known as: Cementless Oxford Unicompartmental Knee Replacement

Cementless Oxford Unicompartmental Knee Arthroplasty

Cemented Oxford Unicompartmental Knee Arthroplasty DEVICE

All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.

Also known as: Cemented Oxford Unicompartmental Knee Replacement

Cemented Oxford Unicompartmental Knee Arthroplasty

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Subjects with osteoarthritis of knee fulfilling the standard indications for an Oxford Unicompartmental Knee Replacement.
• American Society of Anaesthesiologists (ASA) Score of 1 to 3.

You may not qualify if:

• Subjects with severe limiting systemic illness (i.e. ASA \> 3).
• Subjects who are too large for radiostereometric analysis to be carried out.
• Subjects who have had previous open surgery or anterior cruciate ligament (ACL) reconstruction on the same knee.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Related Publications (2)

• Kendrick BJ, Kaptein BL, Valstar ER, Gill HS, Jackson WF, Dodd CA, Price AJ, Murray DW. Cemented versus cementless Oxford unicompartmental knee arthroplasty using radiostereometric analysis: a randomised controlled trial. Bone Joint J. 2015 Feb;97-B(2):185-91. doi: 10.1302/0301-620X.97B2.34331.

  PMID: 25628280 RESULT

• Campi S, Kendrick BJL, Kaptein BL, Valstar ER, Jackson WFM, Dodd CAF, Price AJ, Murray DW. Five-year results of a randomised controlled trial comparing cemented and cementless Oxford unicompartmental knee replacement using radiostereometric analysis. Knee. 2021 Jan;28:383-390. doi: 10.1016/j.knee.2020.09.003. Epub 2021 Jan 4.

  PMID: 33408039 RESULT

Related Links

• Publication of 2-year results
• Abstract of the (partial) 10-year results

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

At 10 years, loss to follow-up meant there were less than 16 knees in each group required by the power calculation for the study. Maximum Total Point Motion (MTPM) was used as an overall indicator of migration, however the utility of MTPM is limited as it compounds measurement errors so tends to overestimate migration. As the study was powered to detect differences in migration using RSA, the patient numbers were too small to detect differences in clinical outcome.

Results Point of Contact

• Title: Professor David W Murray
• Organization: University of Oxford, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences

david.murray@ndorms.ox.ac.uk

+44 01865 27457

Study Officials

• David W Murray, MA, MD, FRCS

  University of Oxford

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: Patients will be randomised to receive either a cementless or cemented Oxford Unicompartmental Knee Arthroplasty.

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: July 7, 2023
• Study Start: November 8, 2002
• Primary Completion: March 11, 2022
• Study Completion: March 11, 2022
• Last Updated: September 23, 2024
• Results First Posted: February 16, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share