Optihip: Optimys Femoral Stem for Total Hip Replacement

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Completed
• CT.gov ID: NCT03951948
• Collaborator: (none)
• Enrollment: 453
• Location: 1
• Actual Duration (Months): 25.8
• Patients Per Site Per Month: 17.6

Study Details

Study Description

Brief Summary

This retrospective observational study analyses the surgical performance, clinical and radiologic outcome as well as the rate of infections with a main focus on revision surgeries after primary implantation of the Optimys short stem femoral prosthesis.

Condition or Disease	Intervention/Treatment	Phase
Short Stem Prosthesis; Optimys Femoral Stem	Other: retrospective analysis of surgical performance, clinical and radiologic outcome

Study Design

• Study Type: Observational
• Actual Enrollment: 453 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Optimys Femoral Stem for Total Hip Replacement - a Clinical and Radiologic Follow-up of Minimum One Year
• Actual Study Start Date: Apr 16, 2019
• Actual Primary Completion Date: Jun 9, 2021
• Actual Study Completion Date: Jun 9, 2021

Outcome Measures

Primary Outcome Measures

1. rate of reoperations [one year follow-up period after Optimys femoral stem surgery]

   rate of reoperations after primary implantation of the Optimys short stem prosthesis

Secondary Outcome Measures

1. rate of cortical hypertrophy [at one year follow-up after Optimys femoral stem surgery]

   rate of cortical hypertrophy

2. rate of fractures [one year follow-up period after Optimys femoral stem surgery]

   rate of fractures after the implantation of short stem femoral implants

3. rate of infections [one year follow-up period after Optimys femoral stem surgery]

   rate of infections after the implantation of short stem femoral implants

4. anatomic alignment on anterior-posterior (ap) view in Degree° [at one year follow-up after Optimys femoral stem surgery]

   radiologic outcome defined by preciseness of the anatomic alignment compared to the contralateral side

5. subsidence [at one year follow-up after Optimys femoral stem surgery]

   radiologic outcome defined by rate of subsidence after the implantation of short stem femoral implants (mm)

6. pain at rest (yes/no) [at one year follow-up after Optimys femoral stem surgery]

   clinical outcome defined by pain at rest (yes/no)

7. pain under stress (yes/no) [at one year follow-up after Optimys femoral stem surgery]

   clinical outcome defined by pain under stress (yes/no)

8. use of analgetics (yes/no) [at one year follow-up after Optimys femoral stem surgery]

   clinical outcome defined by use of analgetics (yes/no)

9. use of walking aids [at one year follow-up after Optimys femoral stem surgery]

   clinical outcome defined by use of walking aids

10. extent of periarticular ossification (PAO) according to Brooker classification system [at one year follow-up after Optimys femoral stem surgery]

    Brooker classification system divides severity of PAO into 4 types: A: islands of bone within the soft tissues about the hip B: bone spurs originating from the pelvis or proximal end of the femur, leaving at least 1 cm between opposing bone surfaces C: bone spurs originating from the pelvis or proximal end of the femur, reducing the space between opposing bone surfaces to less than 1 cm D: bone ankylosis of the hip

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients treated with an Optimys femoral component at the University Hospital Basel between 29.10.2013 and 29.10.2018

Exclusion Criteria:

• Clinical follow up at another Institution

• Documented dissent in study participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Orthopaedics and Trauma Surgery (DOTS).	Basel		Switzerland	4031

Sponsors and Collaborators

• University Hospital, Basel, Switzerland

Investigators

• Principal Investigator: Martin Clauss, Dr. med, University Hospital, Basel, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT03951948
• Other Study ID Numbers: 2019-00563; ch19Saxer
• First Posted: May 16, 2019
• Last Update Posted: Jun 15, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Basel, Switzerland: total hip replacement

Study Results

No Results Posted as of Jun 15, 2021