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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Oxford Partial Knee Comparative Instrument Pilot Study
Scientific title
A Comparison of Signature Guides and Conventional Instrumentation With the Oxford Partial Knee System Pilot Study
Secondary ID [1] 0 0
ORTHO.CR.GK1 (407)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0

Study type
Description of intervention(s) / exposure
Treatment: Surgery - Conventional Instrumentation
Treatment: Surgery - Signature Custom Guides

Active Comparator: Conventional Oxford instrumentation - Patients who receive an Oxford Partial Knee with Conventional instrumentation.

Experimental: Signature Guides Oxford - Patients who receive an Oxford Partial Knee with Signature Custom Guides

Treatment: Surgery: Conventional Instrumentation
Standard Oxford surgical instruments

Treatment: Surgery: Signature Custom Guides
Signature Custom Guides used with Instruments in surgical technique

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Oxford Knee Score - The Oxford Knee Score is a patient administered questionnaire about how they are functioning and feel about their knee.
Timepoint [1] 0 0
Two Years
Secondary outcome [1] 0 0
Average Operative Time - From incision to incision closure.
Timepoint [1] 0 0
1 Year

Key inclusion criteria
Outside the United States:

-The Oxford Partial Knee System is intended for use in individuals with osteoarthritis or
avascular necrosis limited to the medial compartment of the knee and is intended to be
implanted with bone cement (in the United States). Use of cementless femoral fixation is
permitted outside of the United States only (if it complies with all local, state, and/or
national and international regulations), however the same technique must be used
consistently throughout the course of the study (cemented or cementless).
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- The exclusion criteria will include the same contraindications stated in the FDA
approved labeling for the device (approved in PMA P010014). These contraindications

- Infection, sepsis, and osteomyelitis

- Use in the lateral compartment of the knee

- Rheumatoid arthritis or other forms of inflammatory joint disease

- Revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic
arthritis after tibial plateau fracture

- Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would
preclude stability of the device

- Disease or damage to the lateral compartment of the knee

- Uncooperative patient or patient with neurologic disorders who is incapable of
following directions

- Osteoporosis

- Metabolic disorders which may impair bone formation

- Osteomalacia

- Distant foci of infections which may spread to the implant site

- Rapid joint destruction, marked bone loss, or bone resorption apparent on

- Vascular insufficiency, muscular atrophy, neuromuscular disease

- Incomplete or deficient soft tissue surrounding the knee

- Charcot's disease

- A fixed varus deformity (not passively correctable) of greater than 15 degrees

- A flexion deformity greater than 15 degrees

Study design
Purpose of the study
Basic Science
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Zimmer Biomet

Ethics approval
Ethics application status

Brief summary
The purpose of this prospective clinical data-collection is to document the performance and
clinical outcomes of the Oxford Partial Knee System using Signature Custom Guides and
Conventional Instrumentation.
Trial website
Trial related presentations / publications
Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.
Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg Br. 1998 Jan;80(1):63-9.
Public notes

Principal investigator
Name 0 0
Rod Maxwell
Address 0 0
Canterbury Orthopaedic Services
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications