SCORPIO™: Posterior Cruciate Retaining (PCR) Versus Posterior Cruciate Substituting (PCS) Total Knee Arthroplasty (TKA)

• Sponsor: University of Alberta (Other)
• Overall Status: Completed
• CT.gov ID: NCT02429856
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 170.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This randomized clinical trial (RCT) examined 10 year outcomes comparing SCORPIO™ Posterior Cruciate Substituting (PCS) versus Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) as the primary outcome.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty, Replacement, Knee; Knee Arthroplasty, Total	Device: SCORPIO™	Phase 4

Detailed Description

RCT of 100 subjects undergoing primary TKA who were randomized to received either a SCORPIO™ PCS or PCR TKA.

Subjects were evaluated pre-operatively and at 2 and 10 years post-operatively using the Western Ontario (WOMAC) Osteoarthritis Index, the RAND-36 and knee range of motion (2 years only). Complication and revision rates were also evaluated.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: SCORPIO™ Posterior Stabilized Versus Posterior Retained Total Knee Arthroplasties: Long-term Functional and Radiographic Outcome
• Study Start Date: Feb 1, 1999
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PCS SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis	Device: SCORPIO™; subjects randomized at surgery to receive 1 of the 2 specified implants
Active Comparator: PCR SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis	Device: SCORPIO™; subjects randomized at surgery to receive 1 of the 2 specified implants

Outcome Measures

Primary Outcome Measures

1. Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain [10 years postoperative]

   disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores

2. WOMAC Osteoarthritis Index Function [10 years]

   disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores

Secondary Outcome Measures

1. RAND -36 Health Survey [10 years postoperative]

   generic patient reported health related quality of life measure with 8 dimensions of health - we report the physical function dimension only with scores ranging from 0-100 where higher scores indicate better physical function.

2. Revision Rate [within 10 years of surgery]

   number of participants with revision surgery (ie another surgery on the same knee) for any cause data obtained from patient report and regional administrative databases

3. Number of Complications [within 10 years of surgery]

4. Knee Range of Motion [knee ROM at 2 years postoperative]

   Knee Range of Motion measured as a calculated total of knee flexion + knee extension; measured in degrees

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• scheduled for primary TKA

• non-inflammatory arthritis

• intact Posterior Cruciate Ligament at the time of surgery

Exclusion Criteria:

• required bone grafting of either the femur or tibia

• varus or valgus deformity of > 15 degrees

• previous high tibial osteotomy

• unable to understand or comply with the study requirements

• unable to provide signed informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alberta Health Services - Edmonton zone	Edmonton	Alberta	Canada	TG6 2B7

Sponsors and Collaborators

• University of Alberta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Alberta
• ClinicalTrials.gov Identifier: NCT02429856
• Other Study ID Numbers: Pro00002407
• First Posted: Apr 29, 2015
• Last Update Posted: Jul 27, 2021
• Last Verified: Jul 1, 2021

Study Results

Participant Flow

Arm/Group Title	PCS Group	PCR Group
Arm/Group Description	SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants	SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants
Period Title: Overall Study
STARTED	49	51
COMPLETED	30	32
NOT COMPLETED	19	19

Baseline Characteristics

Arm/Group Title	PCS Group	PCR Group	Total
Arm/Group Description	SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants	SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants	Total of all reporting groups
Overall Participants	49	51	100
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	49 100%	51 100%	100 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.2 (8.4)	69.2 (9.1)	69.7 (8.6)
Sex: Female, Male (Count of Participants)
Female	22 44.9%	27 52.9%	49 49%
Male	27 55.1%	24 47.1%	51 51%
Region of Enrollment (Count of Participants)
Canada	49 100%	51 100%	100 100%

Outcome Measures

1. Primary Outcome

Title	Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain
Description	disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores
Time Frame	10 years postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCS Group	PCR Group
Arm/Group Description	SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants	SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants
Measure Participants	30	32
Mean (Standard Deviation) [units on a scale]	84.0 (19.8)	78.3 (24.5)

2. Primary Outcome

Title	WOMAC Osteoarthritis Index Function
Description	disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCS Group	PCR Group
Arm/Group Description	SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants	SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants
Measure Participants	26	30
Mean (Standard Deviation) [units on a scale]	67.9 (25.6)	72.7 (23.3)

3. Secondary Outcome

Title	RAND -36 Health Survey
Description	generic patient reported health related quality of life measure with 8 dimensions of health - we report the physical function dimension only with scores ranging from 0-100 where higher scores indicate better physical function.
Time Frame	10 years postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCS Group	PCR Group
Arm/Group Description	SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants	SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants
Measure Participants	30	32
Mean (Standard Deviation) [units on a scale]	42.4 (28.7)	50.3 (29.3)

4. Secondary Outcome

Title	Revision Rate
Description	number of participants with revision surgery (ie another surgery on the same knee) for any cause data obtained from patient report and regional administrative databases
Time Frame	within 10 years of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCS Group	PCR Group
Arm/Group Description	SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants	SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants
Measure Participants	30	32
Count of Participants [Participants]	5 10.2%	2 3.9%

5. Secondary Outcome

Title	Number of Complications
Time Frame	within 10 years of surgery

Outcome Measure Data

Analysis Population Description

These complications include the revisions already recorded.

Arm/Group Title	PCS Group	PCR Group
Arm/Group Description	SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants	SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants
Measure Participants	32	30
Count of Participants [Participants]	6 12.2%	2 3.9%

6. Secondary Outcome

Title	Knee Range of Motion
Description	Knee Range of Motion measured as a calculated total of knee flexion + knee extension; measured in degrees
Time Frame	knee ROM at 2 years postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCS Group	PCR Group
Arm/Group Description	SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants	SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants
Measure Participants	38	40
Mean (Standard Deviation) [degrees]	105.8 (13.5)	105.9 (13.0)

Adverse Events

Arm/Group Title	PCS Group		PCR Group
Arm/Group Description	SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants		SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants
All Cause Mortality
	PCS Group		PCR Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	PCS Group		PCR Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/49 (10.2%)		2/51 (3.9%)
Musculoskeletal and connective tissue disorders
Revision of TKA	5/49 (10.2%)	5	2/51 (3.9%)	2
Other (Not Including Serious) Adverse Events
	PCS Group		PCR Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/51 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.