Active, not recruitingNCT02525601TriathlonRSAUpdated May 7, 2026

Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. Uncemented

An interventional study of Triathlon CR cemented and Triathlon CR uncemented in Arthroplasty, Replacement, Knee, sponsored by Region Skane. Active, not recruiting at 1 site in Sweden. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by Region Skane · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 6 years 3 months after the study started (first participant enrolled Mar 2009, registered Jun 2015).

Phase: Not applicable
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study summary

The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.

Read the detailed description

The evaluation is carried out by a prospective randomised RSA-study with Triathlon CR cemented vs. uncemented.

Conditions studied

Arthroplasty, Replacement, Knee

In context

Lead sponsor

Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients suffering exclusively from osteo arthritis, Stage II-V [Ahlbäck Trauma Score, 1968 391] will be operated.
Patients requiring knee prosthesis, suitable for the use of Duracon and Triathlon knee system
Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographical evaluations and the prescribed rehabilitation.
Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.

Exclusion criteria

Exclusion Criteria:

Previous major knee surgery
Other significant disabling problems from the muscular-skeletal system than in the knees
Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI above 35).
Patients with active or suspected infection.
Patients with malignancy - active malignancy.
Patients with severe osteoporosis, Paget's disease, renal osteodystrophy.
Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.
Female patients planning a pregnancy during the course of the study.
Patients with systemic or metabolic disorders leading to progressive bone deterioration.
Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
Patients with other severe concurrent joint involvements, which can affect their outcome.
Patients with other concurrent illnesses, which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis.
Patients under the protection of law (e.g. guardianship).

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 60 participants (actual)

Study arms

Active comparator
Triathlon CR cemented
Triathlon Cruciate Retaining knee with cemented fixation randomised versus Triathlon Cruciated Retaining knee with uncemented fixation. The aim with this study is to evaluate the uncemented Peri-Apatite (PA) knee fixation and migration properties versus the cemented version.
Device: Triathlon CR cemented
Active comparator
Triathlon CR uncemented
Triathlon Cruciate Retaining knee with cemented fixation randomised versus Triathlon Cruciated Retaining knee with uncemented fixation. The aim with this study is to evaluate the uncemented PA knee fixation and migration properties versus the cemented version.
Device: Triathlon CR uncemented

Interventions

DeviceTriathlon CR cemented
Implantation of Knee Prosthesis
DeviceTriathlon CR uncemented
Implantation of Knee Prosthesis

What researchers measure

Primary outcomes

Assessment of fixation and stability of the Triathlon total knee prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)
Assessment of fixation and stability of the Triathlon total knee prosthesis by Roentgen Stereophotogrammetric as a predictor of late mechanical loosening.
Time frame: 10 years follow-up; UPDATE: time frame extended up to 15 years outcomes

Secondary outcomes

Investigation of patient outcome with radiographic analysis
Plain radiographs will be obtained for assessment of fixation of the device.
Time frame: 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years
Investigation of clinical performance and patient outcome with Knee Society Score (KSS)
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, Range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years
Investigation of clinical performance and patient outcome with Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire
KOOS consists of 5 subscales: Pain, other symptoms, function in daily living, function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years
Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire
The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years

Study locations

1 site

Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm
Hässleholm, Skåne County 281 38, Sweden

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02525601
Lead sponsor: Region Skane
Responsible party: Sponsor
First posted: Aug 17, 2015
Start date: Mar 2009
Primary completion: Dec 1, 2026 (estimated)
Completion: Dec 2026 (estimated)
Last update: May 7, 2026

Study contacts

Sören Toksvig-Larsen, MD

principal investigator · Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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