Condition category
Musculoskeletal Diseases
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
23/11/2006
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R Wagenmakers

ORCID ID

Contact details

University Medical Center Groningen
Department of Orthopaedic Surgery
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 3610553
r.wagenmakers@orth.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

MIS-study

Study hypothesis

It is our hypothesis that Minimally Invasive total hip Surgery (MIS) will lead to better recovery compared to traditional total hip surgery during the early postoperative period (three months), and at least as good at six months postoperatively.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hip diseases

Intervention

Treatment of intervention group:
Patients in the MIS group will have surgery using the minimally invasive single-incision anterior approach. The anterior approach is one of the several possible approaches to the hip joint. Using special retractors, reamers and insertion handles it is possible to perform this procedure in a minimally invasive way, limiting the skin incision from about 15 cm to about 8 cm.

The advantage of the anterior approach is the possibility of using inter-muscular planes, avoiding muscle damage by cutting or detaching muscles and adding to the minimally invasive character of the approach. An anterior incision centred over the hip joint is made in a supine patient. After division of skin and subcutis, the interval between the m. tensor fasciae lata and the m. sartorius is identified and the overlying fascia is opened. In this part of the operation care must be taken to avoid damaging the n. cutaneous femoris lateralis, supplying the skin on the lateral part of the thigh. The intermuscular plane between the m. tensor fasciae lata and the m. sartorius is developed further down to the hip capsule. Subsequently the hip capsule is opened, allowing access to the hip joint.

Preparation of the hip for implantation of a hip prosthesis can take place now, by in situ performance of the collum osteotomy, removal of the femoral head and reaming of the acetabulum, followed by insertion of an uncemented acetabular cup. After reaming of the femur an uncemented femoral component can be placed, followed by placement of a head on the femoral component, repositioning of the joint and closure in layers.

To optimise placement of the acetabular and femoral components of the total hip prosthesis, computer navigation will be used. In order to use computer navigation it is necessary to place two trackers on the patient, which are used by the computer for referencing. These trackers are temporarily fixed on the patient by a small anchoring pin in the pelvis (spina iliaca anterior superior) and in the distal femur.

Treatment of control group:
The minimally invasive technique will be compared to the traditional posterolateral approach, in which the patient is placed in a lateral position. After trans-section of the subcutis, the facia latae and glutae are split. Next, the short external rotators are cut at the level of their insertion at the greater trochanter, so this approach is not muscle-sparing. In this phase of the procedure, caution is advised with the sciatic nerve, the main nerve for the lower leg.

After retraction of the short external rotators backwards, the hip capsule becomes visible and can be incised, allowing access to the hip joint. The rest of the operation will essentially take place in the same manner as the minimally invasive surgical technique.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Does computer-assisted MIS lead to a better recovery during the early postoperative period (three months), and at six months postoperatively to a recovery at least as good as THA with a traditional incision technique?

In this study, recovery is operationalised as 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.

Secondary outcome measures

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?

Overall trial start date

01/01/2007

Overall trial end date

01/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Minimum age of 18 years and maximum of 75 years of age
2. Admitted for primary cement-less unilateral Total Hip Arthroplasty (THA), due to primary or secondary osteoarthrosis

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.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

132

Participant exclusion criteria

1. Inflammatory polyarthritis
2. A history of previous surgery on the affected hip
3. Dementia
4. Not able to fill in questionnaires in the Dutch language

Recruitment start date

01/01/2007

Recruitment end date

01/01/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (UMCG) (The Netherlands)

Sponsor details

Department Orthopaedic Surgery
P.O. Box 30001
Groningen
9700 RB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes