## Protocol Section
### Identification Module
**NCT ID:** NCT00966979

**Acronym:** PKR

**Brief Title:** Triathlon® Partial Knee Replacement (PKR) Outcomes Study

**Official Title:** A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Partial Knee Resurfacing (PKR) Unicondylar Knee System

#### Organization Study ID Info
**ID:** 66
#### Organization
**Class:** INDUSTRY
**Full Name:** Stryker Orthopaedics
### Status Module
#### Completion Date
**Date:** 2023-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-09-13

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-16

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2022-09

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-09-13

**Type:** ACTUAL

**Results First Submit Date:** 2023-07-10

**Results First Submit QC Date:** 2023-08-16

#### Start Date
**Date:** 2010-01

**Type:** ACTUAL

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2009-08-27
**Type:** ESTIMATED
**Study First Submit Date:** 2009-08-25
**Study First Submit QC Date:** 2009-08-25
**Why Stopped:** Enrollment goals not being met.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Stryker Orthopaedics

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to compare the 10-year Knee Society Score (KSS) functional results of the Triathlon PKR Unicondylar Knee to the 10-year Knee Society Score (KSS) functional results of the Triathlon Cruciate Retaining (CR) Total Knee.

### Conditions Module

**Conditions:**

- Arthroplasty, Replacement, Knee

**Keywords:**

- Osteoarthritis, Post-traumatic arthritis

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 111

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All subjects enrolled will receive the Triathlon PKR device.

**Intervention Names:**

- Device: Triathlon PKR

**Label:** Triathlon PKR

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Triathlon PKR

**Description:** Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee.

**Name:** Triathlon PKR

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The Knee Society Score (KSS) consists of two distinct sub-scores: one for pain, range of motion, joint stability and alignment (Pain/Motion KSS) and one for distance walked, stair climbing and walking aids (Functional KSS).

This outcome measure was only for the KSS Function Score at 10-years. The KSS Function score subscale is 0-100, with 100 representing a better outcome. Although the specific scores are not distinguished as "excellent", "good", "fair", or "poor", a higher value represents a better outcome.

**Measure:** Investigation of Clinical Performance and Patient Outcome With the Functional Knee Society Score (KSS).

**Time Frame:** 10 years

#### Secondary Outcomes

**Description:** For the purpose of this study the Kaplan-Meier survival curves are a statistical method to estimate the survival function from lifetime data of a knee replacement after treatment. Survivorship is defined as a percentage of knees free of any component revision for any reason.

**Measure:** 10-years Kaplan Meier Survival Analysis

**Time Frame:** 10-years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* The subject is a male or non-pregnant female 21-75 years of age at the time of enrollment.
* The subject requires a primary cemented unicompartmental knee replacement.
* The subject has a diagnosis of osteoarthritis (OA) or posttraumatic arthritis (TA).
* The subject has clinically intact cruciate and collateral ligaments and no ligamentous instability is present.
* The subject has less than 10 degrees of flexion contracture and greater than 90 degrees of flexion.
* The subject's preoperative mechanical alignment is less than 15 degrees of varus and 15 degrees of valgus.
* The subject has signed the Institutional Review Board (IRB) approved study specific Informed Patient Consent Form.
* The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

* The subject has inflammatory arthritis or avascular necrosis(AVN).
* The subject is obese, BMI \> 35.
* The subject has a history of total or unicompartmental (contralateral compartment and/or patellofemoral joint) reconstruction of the affected joint.
* The subject has a history of anterior cruciate ligament (ACL) reconstruction.
* The subject has had a high distal femoral, or proximal tibial osteotomy.
* The subject has a mental, neuromuscular or neurosensory disorder, which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in post-operative care and/or limit the ability to assess the performance of the device.
* The subject has a systemic or metabolic disorder leading to progressive bone deterioration that the surgeon feels would affect the overall outcome of the study.
* The subject is immunologically suppressed, or is receiving chronic steroids (\>30 days duration).
* The subject has a known sensitivity to device materials.
* The subject's bone stock is compromised by disease and/or infection which cannot provide adequate support and/or fixation to the prosthesis.
* The subject's bone stock is compromised by a prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
* The subject has an active or suspected latent infection in or about the knee joint.
* The subject is a prisoner.

**Maximum Age:** 75 Years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Jacksonville

**Country:** United States

**Facility:** Heekin Orthopaedic Institute for Research, Inc.

**State:** Florida

**Zip:** 32204

**Location 2:**

**City:** Egg Harbor Township

**Country:** United States

**Facility:** Rothman Institute

**State:** New Jersey

**Zip:** 08234

**Location 3:**

**City:** Buffalo

**Country:** United States

**Facility:** Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital

**State:** New York

**Zip:** 14203

**Location 4:**

**City:** Syracuse

**Country:** United States

**Facility:** Syracuse Orthopedic Specialists

**State:** New York

**Zip:** 13214

**Location 5:**

**City:** Media

**Country:** United States

**Facility:** Rothman Institute

**State:** Pennsylvania

**Zip:** 19063

**Location 6:**

**City:** Morrisville

**Country:** United States

**Facility:** Mansfield Orthopaedics

**State:** Vermont

**Zip:** 05661

**Location 7:**

**City:** Stollberg

**Country:** Germany

**Facility:** Praxisklinik Stollberg und Arthro. Zentrum GmbH

**Zip:** 09366

**Location 8:**

**City:** Alessandria

**Country:** Italy

**Facility:** Presidlo Ospedaliero Civile Santi Antonio e Biagio

**Zip:** 15100

**Location 9:**

**City:** Hässleholm

**Country:** Sweden

**Facility:** Hassleholm Sygehus Ortopaedkirurgisk afd. Esplanadgatan

#### Overall Officials

**Official 1:**

**Affiliation:** St. Vincent's Medical Center

**Name:** R. David Heekin, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Praxisklinik Stollberg

**Name:** Marco Tinius, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Presidlo Ospedaliero Civile Santi Antonio e Biagio

**Name:** Marco Schiraldi, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** Mansfield Orthopaedics

**Name:** Brian Aros, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 5:**

**Affiliation:** Rothman Institute

**Name:** Fabio Orozco, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 6:**

**Affiliation:** Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital

**Name:** Matthew Phillips, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 7:**

**Affiliation:** Bonutti Clinic

**Name:** Peter Bonutti, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 8:**

**Affiliation:** Hassleholm Sygehus Ortopaedkirurgisk afd.

**Name:** Soren Toksvig-Larsen, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 9:**

**Affiliation:** Syracuse Orthopedic Specialists

**Name:** Brett Greenky, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 10:**

**Affiliation:** Oklahoma Sports Science and Orthopaedics

**Name:** Paul Jacob, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2019-09-26

- Filename: Prot_SAP_ICF_000.pdf

- Has ICF: True

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

- Size: 15048969

- Type Abbrev: Prot_SAP_ICF

- Upload Date: 2023-06-06T13:49

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: LOW

- As Found: Unknown

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.

#### Event Groups

**Group ID:** EG000

**Title:** Operative Adverse Events

**Deaths Num At Risk:** 89

**Description:** Operative site adverse events are reported by knee because in the case of bilateral participants (this is when one participant has both knees enrolled in the study), an event can occur in one knee, both knees or the same knee at different times and are counted separately for this reason.

**ID:** EG000

**Other Num Affected:** 26

**Other Num at Risk:** 89

**Serious Number Affected:** 11

**Serious Number At Risk:** 89

**Title:** Operative Adverse Events

**Group ID:** EG001

**Title:** Non-Operative Adverse Events

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 88

**Description:** Non-operative site adverse events are reported by participant.

**ID:** EG001

**Other Num at Risk:** 88

**Serious Number Affected:** 20

**Serious Number At Risk:** 88

**Title:** Non-Operative Adverse Events

**Frequency Threshold:** 5

#### Other Events

**Term:** Operative

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA

#### Serious Events

**Term:** Non-operative

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA

##### Stats

**Group ID:** EG000

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 88

**Num Events:** 6

**Term:** Non-operative

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA

##### Stats

**Group ID:** EG000

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 88

**Num Events:** 3

**Term:** Non-operative

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA

##### Stats

**Group ID:** EG000

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 88

**Num Events:** 2

**Term:** Operative site

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 89

**Num Events:** 1

**Group ID:** EG001

**Term:** Operative site

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA

##### Stats

**Group ID:** EG000

**Num Affected:** 10

**Num At Risk:** 89

**Num Events:** 10

**Group ID:** EG001

**Term:** Non-operative

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA

##### Stats

**Group ID:** EG000

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 88

**Num Events:** 4

**Term:** Non-operative site

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA

##### Stats

**Group ID:** EG000

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 88

**Num Events:** 1

**Term:** Non-operative

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA

##### Stats

**Group ID:** EG000

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 88

**Num Events:** 2

**Term:** Non-operative

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA

##### Stats

**Group ID:** EG000

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 88

**Num Events:** 1

**Term:** Non-operative

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA

##### Stats

**Group ID:** EG000

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 88

**Num Events:** 1

**Time Frame:** This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 88

**Units:** Participants

### Group

**ID:** BG000

**Title:** Triathlon PKR

**Description:** All subjects enrolled will receive the Triathlon PKR device.

Triathlon PKR: Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee.

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 44

**Upper Limit:** 76

**Value:** 61.83

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 39

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 49

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 86

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** There is an agreement between Principal Investigators and the Sponsor (or its agents) that requires Investigators to allow Sponsor at least 60 days to review material intended for publications to ensure that confidential information is not disclosed and that the data is accurately represented. The investigators can submit publication proposals prior to the study completion date for Sponsor consideration and for up to 7 years after study completion.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** After 13-years the enrollment goal was not met. This led to a protocol amendment to include retrospective cases. These cases were combined with the initial prospective cases and followed prospectively for the planned observation time. This study does not compare prospective to retrospective cases. The retrospectively enrolled cases were followed prospectively and there were no retrospective cases that reached the 10-year time point, only 12 prospective cases had 10-year data.
### Point of Contact
**Email:** StrykerJRClinical@stryker.com
**Organization:** Stryker Orthopaedics
**Phone:** 201-831-5000
**Title:** Stryker JR Clinical Research
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.77
- **Upper Limit:** 
- **Value:** 98.33
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 80.12
- **Spread:** 
- **Upper Limit:** 96.37
- **Value:** 91.35
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The Knee Society Score (KSS) consists of two distinct sub-scores: one for pain, range of motion, joint stability and alignment (Pain/Motion KSS) and one for distance walked, stair climbing and walking aids (Functional KSS).

This outcome measure was only for the KSS Function Score at 10-years. The KSS Function score subscale is 0-100, with 100 representing a better outcome. Although the specific scores are not distinguished as "excellent", "good", "fair", or "poor", a higher value represents a better outcome.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Due to early study termination the primary outcome was only reached for a minimal number of participants (12) reaching 10 years. These only included prospective cases. No retrospective cases reached the 10-year time interval.
**Reporting Status:** POSTED
**Time Frame:** 10 years
**Title:** Investigation of Clinical Performance and Patient Outcome With the Functional Knee Society Score (KSS).
**Type:** PRIMARY
**Type Units Analyzed:** Knees
**Unit of Measure:** units on a scale
##### Group
**Description:** All subjects enrolled will receive the Triathlon PKR device.

Triathlon PKR: Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee for a primary replacement indication.
**ID:** OG000
**Title:** Triathlon PKR Unicompartmental Knee
#### Outcome Measure 2
**Description:** For the purpose of this study the Kaplan-Meier survival curves are a statistical method to estimate the survival function from lifetime data of a knee replacement after treatment. Survivorship is defined as a percentage of knees free of any component revision for any reason.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** This primary outcome measure at 10 years is a statistical estimation based on 80 prospective knees as per the protocol.
**Reporting Status:** POSTED
**Time Frame:** 10-years
**Title:** 10-years Kaplan Meier Survival Analysis
**Type:** SECONDARY
**Type Units Analyzed:** Knees
**Unit of Measure:** percentage of knees
##### Group
**Description:** All subjects enrolled will receive the Triathlon PKR device.

Triathlon PKR: Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee for a primary replacement indication.
**ID:** OG000
**Title:** Triathlon PKR Unicompartmental Knee
### Participant Flow Module
#### Group
**Description:** All subjects enrolled will receive the Triathlon PKR device.

Triathlon PKR: Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee for a primary replacement indication.
**ID:** FG000
**Title:** Triathlon PKR Unicompartmental Knee
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 6
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 14
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
##### Withdraw
**Type:** Sponsor terminated early
###### Reason
**Group ID:** FG000
**Number of Subjects:** 49
##### Withdraw
**Type:** Censored because surgery not done
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Withdraw
**Type:** Censored because study device was not implanted
###### Reason
**Group ID:** FG000
**Number of Subjects:** 14
##### Withdraw
**Type:** Censored because of Inclusion/exclusion violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 111
**Number of Units:** 112
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
**Number of Units:** 13
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 98
**Number of Units:** 99
**Pre-Assignment Details:** Of the 111 participants enrolled, there were 23 cases that were censored due to not having the study device, surgery canceled or an inclusion exclusion violation. Therefore, 89 knees in 88 participants are followed who did receive the study device and met protocol criteria. Those applicable data are reflected in this record.
**Recruitment Details:** There were 112 knees in 111 patients that were enrolled in the study (one bilateral case).
**Type Units Analyzed:** Knees
**Has Results:** True