Frontlight ResearchEarly access
CompletedNo phase
Continuation of Patient Follow-up to 2 Years for the Pinnacle RSA and Pinnacle DM RSA Clinical Trials
Key facts
- Who runs it
- Canadian Radiostereometric Analysis Network
- Where
- Canada2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 82 people enrolled
- Started
- 2 May 2023
- Ended
- 30 May 2025
- Type of study
- Interventional, 2 groups
- Treatments tested
- Pinnacle Gription Acetabular Cup
- Pinnacle Dual Mobility
- Record updated
- 10 December 2025
Who can take part
- Age
- 21 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Individuals who were enrolled on the DSJ_2018_02 and DSJ_2019_02
Who cannot take part
- Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of bone fracture and/or the lack of adequate bone to support the implant(s)
- Individuals who have had a contralateral hip that was implanted less than 6 months prior to the time of consent into this study or individuals that expect to have a contralateral hip implanted in the 6 months following the time of consent into this study. Individuals that have amputations in either leg that would impact rehabilitation following surgery
- Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months
- Individuals have active local or systemic infection
- Individuals with Charcot's or Paget's disease
- Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements
- Individuals diagnosed and taking prescription medications to treat a muscular disorder that limits mobility due to sever stiffness and pain such as fibromyalgia or polymyalgia
- Subject has a medical condition with less than 2 years life expectancy
- Individuals who have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified
- Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA
- Women who are pregnant or lactating
- Individuals who are bedridden per the Investigators determination
- Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims
- Individual has a BMI >45 kg/m2
- DSJ-2019-02 only: Individuals who require revision arthroplasty and have a well-fixed non-DePuy Synthes femoral stem or a well-fixed DePuy Synthes femoral stem that does not have a polished neck
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The proposed study is a continuation of two prospective, multi-centre, non-controlled studies of the Pinnacle and Pinnacle Dual Mobility total hip arthroplasty systems, originally initiated by DePuy Synthes (DSJ_2018_02 and DJS_2019_02, respectively).
The 2 groups in the trial
- Pinnacle GriptionOther group
Pinnacle Gription Acetabular Cup
Treatment: Pinnacle Gription Acetabular Cup
- Pinnacle Dual MobilityOther group
Pinnacle Dual Mobility System
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 10 December 2025