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Comparison of TAM for two relative motion extension orthotic programs (RME full time v RME during the day and a night resting orthosis) following extensor tendon repair in zones V-VI: A randomised pilot study

Analysis of two relative motion extension orthotic programs in patients who have undergone extensor tendon repair in zones V-VI: A randomised pilot study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001241123
Enrollment
5
Registered
2019-09-09
Start date
2019-03-07
Completion date
2020-03-31
Last updated
2019-09-30

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

Conditions

None listed

Brief summary

To prevent rupture of any surgically repaired extensor tendon of the fingers, at least 3 to 6 weeks of splint protection is necessary. The RME finger splint positions the injured metacarpophalangeal joint(s) in greater extension than the neighbouring uninjured metacarpophalangeal joint(s). This restricts motion in the repaired finger tendons to a safe range whilst allowing motion in the intact neighbouring fingers. The aim of this study is to compare two relative motion extension (RME) approaches, with the hypothesis that there are no differences between the groups outcomes: (1) RME splint for daywear and a resting splint overnight for the first 4 weeks post repair (RME +), and (2) use of the RME splint only full time for first 4 weeks post repair (RME-only).

Interventions

The relative motion extension (RME) finger splint positions the injured metacarpophalangeal joint(s) in greater extension than the neighbouring uninjured metacarpophalangeal joint(s). This restricts motion in the repaired finger tendons to a safe range whilst allowing motion in the intact neighbouring fingers. Within the first 10 days after surgery a one-on-one appointment is made with an Occupational Therapist (OT) or Physiotherapist (PT) working in the area of hand therapy with a minimum of 1

The relative motion extension (RME) finger splint positions the injured metacarpophalangeal joint(s) in greater extension than the neighbouring uninjured metacarpophalangeal joint(s). This restricts motion in the repaired finger tendons to a safe range whilst allowing motion in the intact neighbouring fingers. Within the first 10 days after surgery a one-on-one appointment is made with an Occupational Therapist (OT) or Physiotherapist (PT) working in the area of hand therapy with a minimum of 1 years experience in the specialty at the hand therapy clinic. After randomization into one of the two treatment groups, the pre-selected splint(s) [RME or RME plus a night resting splint) will be fabricated by the treating therapist and participants will be asked to attend OT or PT (hand therapy) appointments as per standard postoperative care. Although the splint(s) are worn continuously for the first 4 weeks, patients are supervised in one-on-one therapy for exercise (active flexion and extension of the digits) and instruction to “wean” their use of the splints for 8 to 12 weeks postoperatively.Therapy sessions are booked for 15-30 minutes each (one-one-one) with frequency determined based on progress. It is not uncommon to have the initial session, followed by a review the following week, and then therapy sessions every 2-4 weeks thereafter depending on progress up to approximately 12 weeks after surgery. Outcomes measured during the therapy sessions include range of motion, grip strength, hand function, adherence via patient questionnaire and self-report, and satisfaction.

Sponsors

Austin Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Zone V and/or VI EDC and/or EIP and/or EDM 50-100% tendon laceration with repair The surgeon or surgical team member has deemed the repair suitable for early mobilisation (i.e. repair not tight or fragile, no unrepaired partial tendon lacerations) Repair of 3 or fewer fingers 10 or fewer days since surgical repair of the tendon(s) With or without MCP joint capsular repair Hand fractures assessed by the surgeon or surgical team member as appropriate for early active motion Adult (aged 18 or over) Ability to give written consent and to participate in English

Exclusion criteria

Repair to 4 fingers Repair to extensor pollicis longus Concomitant flexor tendon repair Tenuous tendon repair as assessed by the surgeon or surgical team member Hand fractures deemed unsuitable for early active motion as assessed by the surgeon or surgical team member Inability to give informed consent Unable to understand English Has a condition that will hinder the participant’s ability to comply with the study protocol (e.g. cognitive impairment) Has a condition that may hinder healing (e.g. Diabetes, undergoing cancer treatment)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026