A model-based Roentgen Stereophotogrammetry Analysis (RSA) Randomized Control Trial to evaluate the stability of the cementless Taperloc hip stem in four different treatment groups

Completed

• Conditions: Osteoarthritis, rheumatoid arthritis, avascular necrosis

• Registration Number: NL-OMON23873
• Lead Sponsor: Haaglanden Medical Center, The Hague

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Noninflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis.
- Correction of functional deformity.
- > 18 and < 75 years of age
- Subjects willing to return for follow-up evaluations.
- Subjects able to read and understand Dutch language.

Exclusion Criteria

- lnfection
- Sepsis
- Osteomyelitis
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- Osteoporosis or Osteomalacia
- Metabolic disorders which may impair bone formation
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy or neuromuscular disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint is implant stability at 2 years follow-up. Implant stability is measured with measured with Model-based RSA and reported as subsidence, retroversion and maximum total point motion of the prosthesis.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are implant stability and development (early or late ingrowth) during the pre-defined follow-up periods, standard radiographic parameters which include qualitative femoral and acetabular findings as well as position of the stem and cup, clinical outcomes measured with patient reported outcomes. Other clinical data about the procedure intraoperative/surgical data, survivorship and adverse events will be routinely monitored.<br>