Computer-assisted Minimally Invasive Total Hip Surgery: a randomized controlled trial into the effectiveness compared to traditional Total Hip Arthroplasty.

Computer-assisted Minimally Invasive Total Hip Surgery: a randomized controlled trial into the effectiveness compared to traditional Total Hip Arthroplasty. - MIS-study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29885

Enrollment

132

Registered

2006-10-04

Start date

2007-04-01

Completion date

Unknown

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoarthrosis total hip arthroplasty

Interventions

Patients in the MIS group will have surgery using the minimally invasive single-incision anterior approach. Using special retractors, reamers and insertion handles it is possible to perform this pro

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Primary or secondary osteoarthrosis A minimum age of 18 years A maximum age of 75 years Admitted for a cementless total hip arthroplasty

Exclusion criteria

Exclusion criteria: Inflammatory polyarthritis Previous surgery on the affected hip Dementia Not able to fill in questionnaires in the Dutch language

Design outcomes

Primary

Measure	Time frame
Does computer-assisted MIS lead to a better recovery during the early postoperative period (3 months), and at 6 months postoperatively to a recovery at least as good as THA with a traditional incision technique? In this study, recovery is operationalized as the amount of limping during walking as objectified by gait analysis, and as the self-reported functional status and health-related quality of life.	—

Measure

Time frame

Does computer-assisted MIS lead to a better recovery during the early postoperative period (3 months), and at 6 months postoperatively to a recovery at least as good as THA with a traditional incision technique? In this study, recovery is operationalized as the amount of limping during walking as objectified by gait analysis, and as the self-reported functional status and health-related quality of life.

—

Secondary

Measure	Time frame
Does computer-assisted MIS result in a decreased length of hospital stay compared to THA with a traditional incision technique? Does computer-assisted MIS lead to the same or even better positioning of the prosthesis compared to THA with a traditional incision technique as measured by means of radiographic evaluation? Does computer-assisted MIS lead to a decrease in perioperative complications compared to THA with a standard incision technique? Are there indications that computer-assisted MIS potentially saves costs compared to a traditional incision technique?	—

Measure

Time frame

Does computer-assisted MIS result in a decreased length of hospital stay compared to THA with a traditional incision technique? Does computer-assisted MIS lead to the same or even better positioning of the prosthesis compared to THA with a traditional incision technique as measured by means of radiographic evaluation? Does computer-assisted MIS lead to a decrease in perioperative complications compared to THA with a standard incision technique? Are there indications that computer-assisted MIS potentially saves costs compared to a traditional incision technique?

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)