Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty

A Prospective Randomized Controlled 4-arm Study for the Evaluation of 4 Surgical Techniques in Primary Total Hip Arthroplasty

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01031732

Enrollment

120

Registered

2009-12-15

Start date

2009-11-30

Completion date

2013-12-31

Last updated

2010-05-31

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

Conditions

Arthroplasty, Replacement, Hip

Keywords

Minimally invasive, Total hip arthroplasty, Functional outcome, To compare the surgical results of 4 MIS THA techniques, To investigate the functional outcomes of 4 MIS THA techniques, To study the biochemical parameters after the MIS surgeries.

Brief summary

Current Minimally Invasive THR includes: (1) Minimally Invasive Two-Incision THR (MIS-2), (2) Minimally Invasive Modified Watson-Jones THR (MIS-WJ). In contrast, mini-incision utilizes smaller incision (\< 10 cm in definition) to perform the THR which can further be divided into mini-anterolateral (Mini-AL) and mini-posterolateral (Mini-PL).The purpose of this study is to investigate how MIS THR can affect the results of THR by a prospective randomized clinical trial. It is hoped that some new standards could be established for the total hip replacement surgery.

Detailed description

The prospective randomized study will be performed in patients after obtaining patient's consent. Envelop drawing based on random table will decide the choice of approach. (1) Group 1: MIS-2, 30 cases (2) Group 2: MIS-WJ, 30 cases (3) Group 3: Mini-AL, 30 cases (4) Group 4: Mini-PL, 30 cases. Only the unilateral coxarthrosis will be recruited for the study. Analytical methods include (1) gait analysis (2) cybex study (3) balance test and obstacle crossing test (4) bone densitometry (5) PETS oxygen consumption and glucose utilization tests (6) inflammatory markers (7) clinical assessment (8) X-ray studies. Patients will be scheduled for specified examinations preoperatively, postoperatively and within 5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, and 36 months.

Interventions

PROCEDUREMIS-2 THA

MIS two-incision THA

PROCEDUREMIS-WJ

MIS-Watson Jones THA

PROCEDUREMIS-AL THA

Transgluteal approach

PROCEDUREMIS-PL THA

Posterolateral approach

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Unilateral hip disease that is indicated for primary total hip arthroplasty.

Exclusion criteria

* A previous THA on the contralateral hip. * Any condition contraindicated for primary total hip arthroplasty. * Refuse to be randomized in the study arms.

Design outcomes

Primary

Measure	Time frame
Pain and Harris hip score	5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months

Secondary

Measure	Time frame
Functional outcomes assessment	6 weeks, 3 months, 6 months, 12 months, 24 months

Countries

Taiwan

Contacts

Primary ContactMel S Lee, MD, PhD

mellee@adm.cgmh.org.tw886-968372599

Backup ContactChihling Chou, RN

chihling0930@yahoo.com886-968419384

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026