Post Market Clinical Follow-Up of Plasmafit® Cup

• Sponsor: Aesculap AG (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02019849
• Collaborator: (none)
• Enrollment: 100
• Locations: 2
• Anticipated Duration (Months): 137
• Patients Per Site: 50
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Twelve months follow-up of implant survival and clinical and radiological follow-up of Plasmafit® Cup.

Condition or Disease	Intervention/Treatment	Phase
Total Hip Arthroplasty	Device: Plasmafit® Total Hip Arthroplasty

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Actual Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Dec 1, 2012
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Plasmafit® Total Hip Arthroplasty	Device: Plasmafit® Total Hip Arthroplasty

Outcome Measures

Primary Outcome Measures

1. Implant Survival Rates [10 years]

   Implant survival is analysed at follow-up examinations at 3 months, 12 months, 5 years and 10 years

Secondary Outcome Measures

1. Osteolysis [3 months, 12 months, 5 years, 10 years]

   Radiological Outcome

2. Ossifications [3 months, 12 months, 5 years, 10 years]

   Radiological Outcome

3. Implant Position [3 months, 12 months, 5 years, 10 years]

   Radiological Outcome

4. Migration of Plasmafit® [3 months, 12 months, 5 years, 10 years]

   Radiological Outcome

5. Clinical Outcome [3 months, 12 months, 5 years, 10 years]

   Harris Hip Score

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Minimum age 18 years

• Indication for cementless total hip arthroplasty

• Patient consent for study participation

• Physical and mental willingness to participate at clinical and radiological follow-up

Exclusion Criteria:

• Patient not available for follow-up

• Increased anesthetics risks according to the "American Society of Anesthesiology": ASA IV

• Tumor

• Alcohol or drug abuse

• Permanent cortisone therapy

• Clinically relevant infection

• Pregnancy or planned pregnancy

• Prior interventions like osteotomy, fracture treatment or prior THA at the concerned hip

• Acute fracture at the concerned hip

• Patients needing a cemented hip arthroplasty

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vulpius-Klinik Bad Rappenau	Bad Rappenau		Germany
2	Diakonie-Klinikum Stuttgart	Stuttgart		Germany

Sponsors and Collaborators

• Aesculap AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aesculap AG
• ClinicalTrials.gov Identifier: NCT02019849
• Other Study ID Numbers: AAG-O-H-1213
• First Posted: Dec 24, 2013
• Last Update Posted: May 10, 2022
• Last Verified: May 1, 2022

• Keywords provided by Aesculap AG: THA, Plasmafit®

Study Results

No Results Posted as of May 10, 2022