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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24337

Enrollment

132

Registered

2006-09-08

Start date

2007-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Computer-assisted minimally invasive total hip surgery versus traditional total hip surgery.

Interventions

Treatment of intervention group Patients in the MIS group will have surgery using the minimally invasive single-incision anterior approach (Rachbauer et al., 2004). The anterior approach is one of th

Eligibility

Inclusion criteria

Inclusion criteria: Patients with a minimum age of 18 years and a maximum of 75 years of age who are admitted for primary cementless unilateral THA, due to primary or secondary osteoarthrosis, will be included. Prior to providing informed consent, patients will be made aware that they will be blinded to the size of the incision for the duration of the hospital stay.

Exclusion criteria

Exclusion criteria: Patients with inflammatory polyarthritis or with a history of previous surgery on the affected hip will be excluded. Additionally patients with dementia and patients who are 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 operationalised as the the proportion of subjects with normal gait (no 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 operationalised as the the proportion of subjects with normal gait (no limping during walking) as objectified by gait analysis, and as the self-reported functional status and health-related quality of life.

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Secondary

Measure	Time frame
1. Does computer-assisted MIS result in a decreased length of hospital stay compared to THA with a traditional incision technique? 2. 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? 3. Does computer-assisted MIS lead to a decrease in perioperative complications compared to THA with a traditional incision technique? 4. Are there indications that computer-assisted MIS potentially saves costs compared to a traditional incision technique?	—

Measure

Time frame

1. Does computer-assisted MIS result in a decreased length of hospital stay compared to THA with a traditional incision technique? 2. 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? 3. Does computer-assisted MIS lead to a decrease in perioperative complications compared to THA with a traditional incision technique? 4. Are there indications that computer-assisted MIS potentially saves costs compared to a traditional incision technique?

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Contacts

Public ContactR. Wagenmakers

University Medical Center Groningen (UMCG) Department of Orthopaedic Surgery P.O. Box 30001

r.wagenmakers@orth.umcg.nl+31 (0)50 3610553

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)