An Electronic Data Capture Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01134445
• Date of registration: 05/03/2010
• Prospective Registration: No
• Primary sponsor: DePuy International
• Public title: An Electronic Data Capture Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement
• Scientific title: Prospective, International Multi-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of the DePuy PROXIMA™ Hip in Subjects With Indications Suitable for a Primary Total Hip Arthroplasty
• Date of first enrolment: February 1, 2010
• Target sample size: 42
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01134445
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Czech Republic, France, Portugal, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female subjects between 18 and 70 years of age.

- Subjects who are able to give voluntary, written informed consent to participate in
this investigation and from whom consent has been obtained.

- Subjects who, in the opinion of the Investigator, are able to understand this
investigation, co-operate with the investigational procedures and agree to return to
the hospital for all the required post-operative follow-ups.

- Subjects who are scheduled to undergo a primary THR whom the surgeon considers to be
suitable for the DePuy PROXIMATM hip femoral prosthesis.

Exclusion Criteria:

- Subjects with active local or systemic infection

- Subjects with loss of musculature, neuromuscular compromise or vascular deficiency in
the affected limb rendering the procedure unjustified.

- Subjects 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 fracture of the femoral shaft and/or the lack of adequate bone to support
the implant(s).

- Subjects with Charcot's or Paget's disease.

- Subjects with hip dysplasia with severe neck anteversion or severe dysplasia of the
proximal femur.

- Subjects with severe osteoporosis.

- Subjects with previous proximal femoral fractures.

- Subjects who, in the opinion of the Investigator, have an existing
condition/co-morbidity or infection that would compromise their long-term
participation and follow-up in this study.

- Women who are pregnant.

- Subjects who are known drug or alcohol abusers or with psychological disorders that
could affect follow-up care or treatment outcomes.

- Subjects who have participated in a clinical study with an investigational product in
the last 6 month(s).

- Subjects who are currently involved in any injury litigation claims.

- Subjects for whom the surgical procedure is a revision of a previous THR,
hemi-arthroplasty or hip resurfacing

- Subjects who have previously undergone osteotomy or arthrodesis of the hip.

- Subjects undergoing a simultaneous bilateral hip operation.

- Subjects undergoing the second stage of a staged bilateral for whom the contralateral
hip is part of this clinical investigation.

- Subjects undergoing the second stage of a staged bilateral for whom the contralateral
hip was implanted less than six months previously or is not performing satisfactorily



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Post-traumatic Arthritis

Rheumatoid Arthritis

Traumatic Femoral Fractures

Congenital Hip Dysplasia

Osteoarthritis

Avascular Necrosis

Intervention(s)

Device: DePuy Proxima™ Hip

Primary Outcome(s)

Kaplan-Meier survivorship calculated at the five-year time-point [Time Frame: 5yrs post surgery]

Secondary Outcome(s)

Annual Kaplan-Meier survivorship calculations [Time Frame: 10yrs post-surgery]

Annual Kaplan-Meier survivorship calculations [Time Frame: 15yrs post-surgery]

Annual Kaplan-Meier survivorship calculations [Time Frame: 7yrs post-surgery]

EuroQol EQ-5D [Time Frame: 10yrs post-surgery]

EuroQol EQ-5D [Time Frame: 15yrs post-surgery]

EuroQol EQ-5D [Time Frame: 6mths post-surgery]

EuroQol EQ-5D [Time Frame: 12yrs post-surgery]

EuroQol EQ-5D [Time Frame: 14yrs post-surgery]

EuroQol EQ-5D [Time Frame: 4yrs post-surgery]

Hip Outcome Score [Time Frame: 1yr post-surgery]

EuroQol EQ-5D [Time Frame: 7yrs post-surgery]

Harris Hip Score [Time Frame: 10yrs post-surgery]

Hip Outcome Score [Time Frame: 6yrs post-surgery]

Oxford Hip Score [Time Frame: 12yrs post-surgery]

Harris Hip Score [Time Frame: 15yrs post-surgery]

Harris Hip Score [Time Frame: 6mths post-surgery]

Annual Kaplan-Meier survivorship calculations [Time Frame: 9yrs post-surgery]

EuroQol EQ-5D [Time Frame: 3mths post-surgery]

Radiographic Analysis [Time Frame: 6mths post-surgery]

UCLA Activity Score [Time Frame: 10yrs post-surgery]

Hip Outcome Score [Time Frame: 2yrs post-surgery]

Hip Outcome Score [Time Frame: 9yrs post-surgery]

Annual Kaplan-Meier survivorship calculations [Time Frame: 6yrs post-surgery]

EuroQol EQ-5D [Time Frame: 13yrs post-surgery]

Annual Kaplan-Meier survivorship calculations [Time Frame: 2yrs post-surgery]

EuroQol EQ-5D [Time Frame: 9yrs post-surgery]

EuroQol EQ-5D [Time Frame: 2yrs post-surgery]

EuroQol EQ-5D [Time Frame: 3yrs post-surgery]

Hip Outcome Score [Time Frame: 10yrs post-surgery]

Hip Outcome Score [Time Frame: 11yrs post-surgery]

Annual Kaplan-Meier survivorship calculations [Time Frame: 14yrs post-surgery]

Annual Kaplan-Meier survivorship calculations [Time Frame: 1yr post-surgery]

EuroQol EQ-5D [Time Frame: 1yr post-surgery]

Hip Outcome Score [Time Frame: 15yrs post-surgery]

Oxford Hip Score [Time Frame: 6yrs post-surgery]

Oxford Hip Score [Time Frame: 9yrs post surgery]

Hip Outcome Score [Time Frame: 6mths post-surgery]

Oxford Hip Score [Time Frame: 10yrs post-surgery]

Hip Outcome Score [Time Frame: 13yrs post-surgery]

Hip Outcome Score [Time Frame: 3mths post-surgery]

Hip Outcome Score [Time Frame: 12yrs post-surgery]

Hip Outcome Score [Time Frame: 14yrs post-surgery]

Oxford Hip Score [Time Frame: 14yrs post-surgery]

Oxford Hip Score [Time Frame: 4yrs post-surgery]

Radiographic Analysis [Time Frame: 1yr post-surgery]

UCLA Activity Score [Time Frame: 4yrs post-surgery]

Harris Hip Score [Time Frame: 2yrs post-surgery]

Harris Hip Score [Time Frame: 5yrs post-surgery]

Oxford Hip Score [Time Frame: 1yr post-sugery]

Oxford Hip Score [Time Frame: 2yrs post-surgery]

Oxford Hip Score [Time Frame: 3mths post-surgery]

Oxford Hip Score [Time Frame: 7yrs post-surgery]

Annual Kaplan-Meier survivorship calculations [Time Frame: 3yrs post-surgery]

Annual Kaplan-Meier survivorship calculations [Time Frame: 4yrs post-surgery]

Radiographic Analysis [Time Frame: 5yrs post-surgery]

UCLA Activity Score [Time Frame: 11yrs post-surgery]

UCLA Activity Score [Time Frame: 1yr post-surgery]

UCLA Activity Score [Time Frame: 6yrs post-surgery]

UCLA Activity Score [Time Frame: 8yrs post-surgery]

EuroQol EQ-5D [Time Frame: 5yrs post-surgery]

EuroQol EQ-5D [Time Frame: 8yrs post-surgery]

Hip Outcome Score [Time Frame: 7yrs post-surgery]

Hip Outcome Score [Time Frame: 8yrs post-surgery]

Oxford Hip Score [Time Frame: 3yrs post-surgery]

Oxford Hip Score [Time Frame: 5yrs post-surgery]

Radiographic Analysis [Time Frame: 10yrs post-surgery]

Radiographic Analysis [Time Frame: 15 yrs post-surgery]

Radiographic Analysis [Time Frame: 2yrs post-surgery]

Radiographic Analysis [Time Frame: 3mths post-surgery]

UCLA Activity Score [Time Frame: 12yrs post-surgery]

UCLA Activity Score [Time Frame: 14yrs post-surgery]

UCLA Activity Score [Time Frame: 15yrs post-surgery]

UCLA Activity Score [Time Frame: 6mths post-surgery]

UCLA Activity Score [Time Frame: 13yrs post-surgery]

UCLA Activity Score [Time Frame: 7yrs post-surgery]

UCLA Activity Score [Time Frame: 9yrs post-surgery]

UCLA Activity Score [Time Frame: 5yrs post-surgery]

Annual Kaplan-Meier survivorship calculations [Time Frame: 11yrs post-surgery]

Annual Kaplan-Meier survivorship calculations [Time Frame: 12yrs post-surgery]

Annual Kaplan-Meier survivorship calculations [Time Frame: 13yrs post-surgery]

Annual Kaplan-Meier survivorship calculations [Time Frame: 8yrs post-surgery]

EuroQol EQ-5D [Time Frame: 11yrs post-surgery]

EuroQol EQ-5D [Time Frame: 6yrs post-surgery]

Harris Hip Score [Time Frame: 1yr post-surgery]

Hip Outcome Score [Time Frame: 3yrs post-surgery]

Hip Outcome Score [Time Frame: 4yrs post-surgery]

Hip Outcome Score [Time Frame: 5yrs post-surgery]

Oxford Hip Score [Time Frame: 11yrs post-surgery]

Oxford Hip Score [Time Frame: 13yrs post-sugery]

Oxford Hip Score [Time Frame: 15yrs post-surgery]

Oxford Hip Score [Time Frame: 6mths post-surgery]

Oxford Hip Score [Time Frame: 8yrs post-surgery]

UCLA Activity Score [Time Frame: 2yrs post-surgery]

UCLA Activity Score [Time Frame: 3mths post-surgery]

UCLA Activity Score [Time Frame: 3yrs post-surgery]

Secondary ID(s)

CT07/02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors