Squeaking in Ceramic-on-Ceramic Total Hip Arthroplasty Using Delta TT Cup

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04594564
• Collaborator: LIMA Korea (Other)
• Enrollment: 270
• Location: 1
• Anticipated Duration (Months): 39
• Patients Per Site Per Month: 6.9

Study Details

Study Description

Brief Summary

This study will evaluate clinical outcome on patients who undergo ceramic on ceramic (CoC) bearing total hip arthroplasty (THA) using Delta TT cup.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Hip; Osteonecrosis of Femoral Head; Femoral Neck Fractures; Rheumatoid Arthritis of Hip; Posttraumatic Arthropathy	Procedure: Total hip arthroplasty with Delta TT cup

Detailed Description

This study will evaluate clinical outcome on patients who undergo ceramic on ceramic (CoC) bearing total hip arthroplasty (THA) using Delta TT cup. Specifically the study intends to address the following research topics:

1. The incidence of squeaking after CoC THA using Delta TT cup.

2. The dislocation rate and survival rate of CoC THA using Delta TT cup.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 270 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Squeaking in Ceramic-on-Ceramic Total Hip Arthroplasty Using Delta TT Cup
• Actual Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2023

Outcome Measures

Primary Outcome Measures

1. Squeaking [6 weeks]

   Rate of any noise after THA

2. Squeaking [3 months]

   Rate of any noise after THA

3. Squeaking [6 months]

   Rate of any noise after THA

4. Squeaking [9 months]

   Rate of any noise after THA

5. Squeaking [12 months]

   Rate of any noise after THA

6. Squeaking [24 months]

   Rate of any noise after THA

Secondary Outcome Measures

1. Dislocation [6 weeks]

   Dislocation rate after THA

2. Dislocation [3 months]

   Dislocation rate after THA

3. Dislocation [6 months]

   Dislocation rate after THA

4. Dislocation [9 months]

   Dislocation rate after THA

5. Dislocation [12 months]

   Dislocation rate after THA

6. Dislocation [24 months]

   Dislocation rate after THA

Other Outcome Measures

1. Range of motion [24 months]

   Change of range of motion after THA

2. Survivorship of implant [24 months]

   Survival rate of prosthesis

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Older than 18 years old

• Non-inflammatory degenerative joint disease such as osteoarthritis or avascular necrosis

• Rheumatoid arthritis

• Post-traumatic arthritis

• Fractures of femoral neck

Exclusion Criteria:

• Local or systemic infection

• Septicaemia

• Persistent acute or chronic osteomyelitis

• Confirmed nerve or muscle lesion compromising hip joint function

• Unstable medical illness

• Rapidly progressive neurological disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do	Korea, Republic of	13620

Sponsors and Collaborators

• Seoul National University Hospital
• LIMA Korea

Investigators

• Principal Investigator: Young-Kyun Lee, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Young-Kyun Lee, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04594564
• Other Study ID Numbers: Delta TT cup
• First Posted: Oct 20, 2020
• Last Update Posted: Nov 9, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Young-Kyun Lee, Professor, Seoul National University Hospital: Total hip arhtroplasty; Squeaking; Dislocation; Ceramic bearings
• Additional relevant MeSH terms: Osteonecrosis; Osteoarthritis, Hip; Femoral Neck Fractures

Study Results

No Results Posted as of Nov 9, 2021