Trial Outcomes & Findings for A Study to Compare the Press Fit Condylar (P.F.C.) Sigma Rotating-platform High-flexion (RP-F) Versus the Press Fit Condylar (P.F.C.) Sigma Rotating-platform (RP) Knee Implants (NCT NCT00733369)

Results Overview

Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

106 participants

Primary outcome timeframe

1 year

Results posted on

2016-09-13

Participant Flow

2 sites enrolled 106 knees in 98 subjects who were then randomized into 2 groups, 50 into the PFC Sigma RP-F group and 56 into the PFC Sigma RP group.

Study protocol was designed and executed on using 'knees' as study units.

Participant milestones

Participant milestones
Measure	PFC Sigma RP-F PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing	PFC Sigma RP PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Study STARTED	50	56
Overall Study COMPLETED	40	47
Overall Study NOT COMPLETED	10	9

Reasons for withdrawal

Reasons for withdrawal
Measure	PFC Sigma RP-F PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing	PFC Sigma RP PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Study Lost to Follow-up	2	1
Overall Study Adverse Event	4	4
Overall Study Protocol Violation	4	4

Baseline Characteristics

A Study to Compare the Press Fit Condylar (P.F.C.) Sigma Rotating-platform High-flexion (RP-F) Versus the Press Fit Condylar (P.F.C.) Sigma Rotating-platform (RP) Knee Implants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PFC Sigma RP-F n=50 Participants 125 patients to be allocated to this arm according to blinding envelopes PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing	PFC Sigma RP n=56 Participants 125 patients to be allocated to this arm according to blinding envelopes PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing	Total n=106 Participants Total of all reporting groups
Age, Continuous	65.2 years STANDARD_DEVIATION 7.2 • n=5 Participants	66.3 years STANDARD_DEVIATION 6.4 • n=7 Participants	65.8 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	42 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment Spain	48 participants n=5 Participants	52 participants n=7 Participants	100 participants n=5 Participants
Region of Enrollment United Kingdom	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: 106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths + 8 Protocol Violations(bilaterals accrued at site where bilateral not allowed, used first knee operated upon: 4 investigational \&4 control) + 2 lost to follow up (1 Inv \& 1 Contr) + 1 missing outcome (1 Inv \& 0 Contr)}

Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.

Outcome measures

Outcome measures
Measure	PFC Sigma RP-F n=44 Number of Knees PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing	PFC Sigma RP n=51 Number of Knees PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Change From Pre-op to 1 Year Range of Motion.	13.11 Degrees Standard Deviation 14.89	10.71 Degrees Standard Deviation 14.38

SECONDARY outcome

Timeframe: 3-6 months

Population: 106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv \& 4Contr)+1 Lost to follow up(1Inv \& 0Contr)+2 Missing outcome(1Inv \& 1Contr)}

The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).

Outcome measures

Outcome measures
Measure	PFC Sigma RP-F n=44 Number of Knees PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing	PFC Sigma RP n=51 Number of Knees PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
To Compare the Change in KOOS Pain Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	39.7 Points Standard Deviation 21.7	46.5 Points Standard Deviation 18.0

SECONDARY outcome

Timeframe: 1 year

Population: 106 enrolled knees, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (Bilaterals accrued at site where bilaterals are not allowed, used 1st knee operated upon: 4 investigational\&4control)+ 2 lost to follow up (1 Inv, 1 Contr)+ 1 missing outcome (0Inv, 1 Contr)}

The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).

Outcome measures

Outcome measures
Measure	PFC Sigma RP-F n=45 Number of Knees PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing	PFC Sigma RP n=50 Number of Knees PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
To Compare the Change in KOOS Pain Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	45.0 Points Standard Deviation 20.5	48.9 Points Standard Deviation 19.4

SECONDARY outcome

Timeframe: 2 years

Population: 106 enrolled knees, 15 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violation (4 Inv, 4 Contr) + 4 Revisions (1 Inv, 3 Contr) + 3 Lost to follow up (2 Inv, 1 Contr)}

The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).

Outcome measures

Outcome measures
Measure	PFC Sigma RP-F n=43 Number of Knees PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing	PFC Sigma RP n=48 Number of Knees PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
To Compare the Change in KOOS Pain Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	43.3 Points Standard Deviation 21.3	47.8 Points Standard Deviation 20.1

Adverse Events

PFC Sigma RP-F

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

PFC Sigma RP

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PFC Sigma RP-F n=50 participants at risk PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing	PFC Sigma RP n=56 participants at risk PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Cardiac disorders Cardiac disorder	0.00% 0/50 • The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early. Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.	1.8% 1/56 • Number of events 1 • The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early. Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/50 • The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early. Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.	1.8% 1/56 • Number of events 1 • The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early. Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.
Musculoskeletal and connective tissue disorders Joint crepitation	6.0% 3/50 • Number of events 3 • The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early. Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.	3.6% 2/56 • Number of events 2 • The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early. Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.
Injury, poisoning and procedural complications Joint dislocations	0.00% 0/50 • The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early. Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.	3.6% 2/56 • Number of events 2 • The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early. Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Malignant	6.0% 3/50 • Number of events 3 • The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early. Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.	1.8% 1/56 • Number of events 1 • The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early. Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.
General disorders Pain	8.0% 4/50 • Number of events 4 • The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early. Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.	3.6% 2/56 • Number of events 2 • The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early. Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.
Immune system disorders Allergy to metals	2.0% 1/50 • Number of events 1 • The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early. Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.	0.00% 0/56 • The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early. Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.
Infections and infestations Infection	2.0% 1/50 • Number of events 1 • The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early. Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.	0.00% 0/56 • The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early. Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.

Other adverse events

Adverse event data not reported

Additional Information

Kimberly Dwyer, PhD, CCRA

DePuy Ortho Joint US

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee DePuy reserves the right to review the contents of publications in advance.The PI may freely disclose the trial results only after DePuy has been given the opportunity of reviewing the proposed results communications at least 30 days prior to the intended release.DePuy will advise the PI of any perceived errors,omissions or corrections but the PI will retain final editorial control.In case of disagreement,DePuy and the PI will make every effort to meet in order to discuss and resolve any issues.
Publication restrictions are in place

Restriction type: OTHER